Machine-Learning and Mass Spectrometer at the Heart of UC Davis COVID-19 Rapid Test

UC Davis Health, in partnership with SpectraPass, is evaluating a new type of rapid COVID-19 test. The research will involve about 2,000 people in Sacramento and Las Vegas.

The idea behind the new platform is a scalable system that can quickly and accurately perform on-site tests for hundreds or potentially thousands of people.

Nam Tran is a professor of clinical pathology in the UC Davis School of Medicine and a co-developer of the novel testing platform with SpectraPass, a Las Vegas-based startup.

Tran explained that the system doesn’t look for the SARS-CoV-2 virus like a PCR test does. Instead, it detects an infection by analyzing the body’s response to it. When ill, the body produces differing protein profiles in response to infection. These profiles may indicate different types of infection, which can be detected by machine learning.

“The goal of this study is to have enough COVID-19 positive and negative individuals to train our machine learning algorithm to identify patients infected by SARS-CoV-2,” said Tran.

A study published by Tran and his colleagues earlier this year in Nature Scientific Reports found the novel method to be 98.3% accurate for positive COVID-19 tests and 96% for negative tests. 

In addition to identifying positive cases of COVID-19, the platform also uses next-generation sequencing to confirm multiple respiratory pathogens like the flu and the common cold.

The sequencing panel at UC Davis Health can detect over 280 respiratory pathogens, including SARS-CoV-2 and related variants — allowing the study to train the machine-learning algorithms to differentiate COVID-19 from other respiratory diseases.

So far, the study has not seen any participants with the new omicron variant.

“Our team has tested the system with samples from patients infected with delta and other variants of the SARS-CoV-2 virus. We are fairly certain that omicron will be detected as well, but we won’t know for sure until we encounter a study participant with the variant,” Tran said.

The Emergency Department (ED) at the UC Davis Medical Center is conducting the testing in Sacramento. Collection for testing in Las Vegas is conducted at multiple businesses and locations.

The team expects the study will continue until the end of winter. The results from the new study will be used to seek emergency use authorization (EUA) from the Food and Drug Administration.

Testing system builds on MILO

The novel testing system uses an analytical instrument known as a mass spectrometer. It’s paired with machine learning algorithms produced by software called the Machine Intelligence Learning Optimizer or MILO. MILO was developed by Tran, Hooman Rashidi, a professor in the Department of Pathology and Laboratory Medicine, and Samer Albahra, assistant professor and medical director of pathology artificial intelligence in the Department of Pathology and Laboratory Medicine.

As with many other COVID-19 tests, a nasal swab is used to collect a sample. Proteins from the nasal sample are ionized with the mass spectrometer’s laser, then measured and analyzed by the MILO machine learning algorithms to generate a positive or negative result.

In addition to conducting the mass spectrometry testing, UC Davis serves as a reference site for the study, performing droplet digital PCR (ddPCR) tests, the “gold standard” for COVID-19 testing, to assess the accuracy of the mass spectrometry tests.

University-industry partnership formed in 2020

The project originated with Maurice J. Gallagher, Jr., chairman and CEO of Allegiant Travel Company and founder of SpectraPass. Gallagher is also a UC Davis alumnus and a longtime supporter of innovation and entrepreneurship at UC Davis.  

In 2020, when the COVID-19 pandemic brought the travel and hospitality industries almost to a standstill, Gallagher began conceptualizing approaches to allow people to gather again safely. He teamed with researchers at UC Davis Health to develop the new platform and launched SpectraPass.

In addition to the novel testing solution, SpectraPass is also developing digital systems to accompany the testing technology. Those include tools to authenticate and track verified test results from the system so an individual can access and use them. The goal is to facilitate accurate, large-scale rapid testing that will help keep businesses and the economy open through the current and any future pandemics.

“The official start of our multi-center study across multiple locations marks an important milestone in our journey at SpectraPass. We are excited to test and generate data on a broader scale. Our goal is to move the platform from a promising new technology to a proven solution that can ultimately benefit the broader population,” said Greg Ourednik, president of SpectraPass.

Source: UC Davis Newsroom 

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SMART Researchers Develop Method for Early Detection of Bacterial Infection in Crops

Researchers from the Disruptive and Sustainable Technologies for Agricultural Precision (DiSTAP) Interdisciplinary Research Group (IRG) of Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, and their local collaborators from Temasek Life Sciences Laboratory (TLL), have developed a rapid Raman spectroscopy-based method for detecting and quantifying early bacterial infection in crops. The Raman spectral biomarkers and diagnostic algorithm enable the noninvasive and early diagnosis of bacterial infections in crop plants, which can be critical for the progress of plant disease management and agricultural productivity.

Due to the increasing demand for global food supply and security, there is a growing need to improve agricultural production systems and increase crop productivity. Globally, bacterial pathogen infection in crop plants is one of the major contributors to agricultural yield losses. Climate change also adds to the problem by accelerating the spread of plant diseases. Hence, developing methods for rapid and early detection of pathogen-infected crops is important to improve plant disease management and reduce crop loss.

The breakthrough by SMART and TLL researchers offers a faster and more accurate method to detect bacterial infection in crop plants at an earlier stage, as compared to existing techniques. The new results appear in a paper titled “Rapid detection and quantification of plant innate immunity response using Raman spectroscopy” published in the journal Frontiers in Plant Science.

“The early detection of pathogen-infected crop plants is a significant step to improve plant disease management,” says Chua Nam Hai, DiSTAP co-lead principal investigator, professor, TLL deputy chair, and co-corresponding author. “It will allow the fast and selective removal of pathogen load and curb the further spread of disease to other neighboring crops.”

Traditionally, plant disease diagnosis involves a simple visual inspection of plants for disease symptoms and severity. “Visual inspection methods are often ineffective, as disease symptoms usually manifest only at relatively later stages of infection, when the pathogen load is already high and reparative measures are limited. Hence, new methods are required for rapid and early detection of bacterial infection. The idea would be akin to having medical tests to identify human diseases at an early stage, instead of waiting for visual symptoms to show, so that early intervention or treatment can be applied,” says MIT Professor Rajeev Ram, who is a DiSTAP principal investigator and co-corresponding author on the paper.

While existing techniques, such as current molecular detection methods, can detect bacterial infection in plants, they are often limited in their use. Molecular detection methods largely depend on the availability of pathogen-specific gene sequences or antibodies to identify bacterial infection in crops; the implementation is also time-consuming and nonadaptable for on-site field application due to the high cost and bulky equipment required, making it impractical for use in agricultural farms.

“At DiSTAP, we have developed a quantitative Raman spectroscopy-based algorithm that can help farmers to identify bacterial infection rapidly. The developed diagnostic algorithm makes use of Raman spectral biomarkers and can be easily implemented in cloud-based computing and prediction platforms. It is more effective than existing techniques as it enables accurate identification and early detection of bacterial infection, both of which are crucial to saving crop plants that would otherwise be destroyed,” explains Gajendra Pratap Singh, scientific director and principal investigator at DiSTAP and co-lead author.

A portable Raman system can be used on farms and provides farmers with an accurate and simple yes-or-no response when used to test for the presence of bacterial infections in crops. The development of this rapid and noninvasive method could improve plant disease management and have a transformative impact on agricultural farms by efficiently reducing agricultural yield loss and increasing productivity.

“Using the diagnostic algorithm method, we experimented on several edible plants such as choy sum,” says DiSTAP and TLL principal investigator and co-corresponding author Rajani Sarojam. “The results showed that the Raman spectroscopy-based method can swiftly detect and quantify innate immunity response in plants infected with bacterial pathogens. We believe that this technology will be beneficial for agricultural farms to increase their productivity by reducing their yield loss due to plant diseases.”

The researchers are currently working on the development of high-throughput, custom-made portable or hand-held Raman spectrometers that will allow Raman spectral analysis to be quickly and easily performed on field-grown crops.

SMART and TLL developed and discovered the diagnostic algorithm and Raman spectral biomarkers. TLL also confirmed and validated the detection method through mutant plants. The research is carried out by SMART and supported by the National Research Foundation of Singapore under its Campus for Research Excellence And Technological Enterprise (CREATE) program.

SMART was established by MIT and the NRF in 2007. The first entity in CREATE developed by NRF, SMART serves as an intellectual and innovation hub for research interactions between MIT and Singapore, undertaking cutting-edge research projects in areas of interest to both Singapore and MIT. SMART currently comprises an Innovation Center and five IRGs: Antimicrobial Resistance, Critical Analytics for Manufacturing Personalized-Medicine, DiSTAP, Future Urban Mobility, and Low Energy Electronic Systems. SMART research is funded by the NRF under the CREATE program.

Led by Professor Michael Strano of MIT and Professor Chua Nam Hai of Temasek Lifesciences Laboratory, the DiSTAP program addresses deep problems in food production in Singapore and the world by developing a suite of impactful and novel analytical, genetic, and biomaterial technologies. The goal is to fundamentally change how plant biosynthetic pathways are discovered, monitored, engineered, and ultimately translated to meet the global demand for food and nutrients. Scientists from MIT, TTL, Nanyang Technological University, and National University of Singapore are collaboratively developing new tools for the continuous measurement of important plant metabolites and hormones for novel discovery, deeper understanding and control of plant biosynthetic pathways in ways not yet possible, especially in the context of green leafy vegetables; leveraging these new techniques to engineer plants with highly desirable properties for global food security, including high-yield density production, and drought and pathogen resistance; and applying these technologies to improve urban farming.

Source: MIT News 

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New Carbon Nanotube-Based Sensor Can Detect SARS-CoV-2 Proteins

As part of a sponsored research collaboration with InnoTech Precision Medicine, researchers from MIT have developed novel nanosensors for the detection of nucleocapsid and spike protein of the SARS-CoV-2 virus in an unprecedented short timeframe, within 10 days. This work was supported by a National Institute of Health, RADx-rad award to Dr. Roya Khosravi-Far, CEO and co-founder of InnoTech Precision Medicine and MIT research team, led by Dr. Michael Strano, the Carbon P. Dubbs Professor of Chemical Engineering.

Work published on October 26, 2021 in Analytical Chemistry describes the optimized and rapid work-flow for development of these innovative antibody-free sensors. Using single-walled carbon nanotubes and polymers, the team has developed Corona Phase Molecular Recognition (CoPhMoRe) sensors for SARS-CoV-2 proteins. These carbon nanotube sensors provide the platform for fast development of rapid and accurate diagnostic, monitoring and surveillance tests for detection of current pathogens as well as for our preparedness for detection of emergent pathogens.

A major drawback of current diagnostic technologies is long development time for antibody-based sensors, which is especially problematic in the case of a new emergent pathogen like COVID-19. “New technologies using innovative material and strategies are key for quick and efficient diagnosis and disease control. Conventional diagnostics are expensive, specialized, and slow to develop; we need to modernize our diagnostic tests to drive robust public health response to existing and emerging threats,” said Dr. Roya Khosravi-Far, Chief Executive Officer and co-founder of InnoTech Precision Medicine.

Reference:

Antibody-Free Rapid Detection of SARS-CoV-2 Proteins Using Corona Phase Molecular Recognition to Accelerate Development Time. Soo-Yeon Cho, Xiaojia Jin,  Xun Gong, Sungyun Yang, Jianqiao Cui, Michael S Strano. Anal Chem. 2021 Nov 9;93(44):14685-14693.  doi: 10.1021/acs.analchem.1c02889. Epub 2021 Oct 26.

LINK: https://pubmed.ncbi.nlm.nih.gov/34698489/

Abstract:

To develop better analytical approaches for future global pandemics, it is widely recognized that sensing materials are necessary that enable molecular recognition and sensor assay development on a much faster scale than currently possible. Previously developed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) point-of-care devices are based on the specific molecular recognition using subunit protein antibodies and protein receptors that selectively capture the viral proteins. However, these necessarily involve complex and lengthy development and processing times and are notoriously prone to a loss of biological activity upon sensor immobilization and device interfacing, potentially limiting their use in applications at scale. Here, we report a synthetic strategy for nanoparticle corona interfaces that enables the molecular recognition of SARS-CoV-2 proteins without any antibody and receptor design. Our nanosensor constructs consist of poly(ethylene glycol) (PEG)─phospholipid heteropolymers adsorbed onto near-infrared (nIR) fluorescent single-walled carbon nanotubes (SWCNTs) that recognize the nucleocapsid (N) and spike (S) protein of SARS-CoV-2 using unique three-dimensional (3D) nanosensor interfaces. This results in rapid and label-free nIR fluorescence detection. This antibody-free nanosensor shows up to 50% sensor responses within 5 min of viral protein injections with limit of detection (LOD) values of 48 fM and 350 pM for N and S proteins, respectively. Finally, we demonstrate instrumentation based on a fiber-optic platform that interfaces the advantages of antibody-free molecular recognition and biofluid compatibility in human saliva conditions.

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HKBU Scientists Develop Barcode Cell Sensor

Research scientists at Hong Kong Baptist University (HKBU) have developed a cell sensor with barcode -like micro-channel structure that allows rapid and low-cost screening of drug-resistant bacteria.

The barcode cell sensor could potentially be used on a large-scale in resource-limited situations such as frequent safety screenings of water, food and public facilities, as well as urgent surveys of massive samples during an infectious disease outbreak, particularly in developing countries.

"Our barcode testing system is a promising new tool in the fight against antimicrobial resistance. We hope
that it will benefit the routine screening of drug-resistant bacteria in the food industry, public areas and healthcare facilities as it does not require advanced clinical facilities or professional testing skills," said Dr. Ren Kangning, associate professor of the Department of Chemistry at HKBU.

Dr. Ren led the research team that designed a fully automatic, microscope-free antimicrobial susceptibility testing (AST) system.  Apart from researchers from HKBU's Department of Chemistry, the research team of the "barcode" cell sensor also included scientists from the Department of Computer Science at HKBU and the School of Medicine at Stanford University.

The team has applied a patent for their invention.

Rapid yet low-cost approach to identifying drug-resistant bacteria

The  overuse and misuse of antibiotics have resulted to drug-resistant bacteria. AST is used to determine which antibiotics can effectively inhibit the growth of a certain type of bacteria effectively.

However, conventional AST methods are too slow, as they require 16 to 24 hours for results, while modern rapid ASTs are expensive and require elaborated laboratory equipment. A rapid and cost-effective strategy is therefore needed to screen bacterial samples onsite, with advanced laboratory testing arranged only for those suspected of containing drug-resistant bacteria.

The barcode cell sensor developed by HKBU enables rapid and low-cost screening of drug-resistant bacteria by scanning the "barcode" on the cell sensor with a mobile app. It is a fully automatic, microscope-free AST system comprising of  two main parts: a cell culture zone and a "barcode" cell sensor.

The cell culture zone consists of a set of micro-channels filled with fluids that contain cell culture media as well as different concentrations of the antibiotic. The "barcode" cell sensor contains an array of "adaptive linear filters" arranged in parallel that resembles a "barcode" structure.

Users can finish the onsite screening within three hours by scanning the "barcode" with a mobile app. Furthermore,  the barcode cell sensor has a  low production cost, estimated at under US$1 per piece.

“We plan to develop our invention into a portable AST instrument, and ultimately, we hope it can be used in resource-limited regions," said Dr. Ren.

How the barcode cell sensor works

When conducting AST with the system, bacterial samples will be injected into and incubated in the cell culture zone. Bacteria in the test sample inside the micro-channels show different proliferation rates depending on different concentrations of the antibiotic.

After completion of the culture period, the bacterial cells will flow through the "adaptive linear filters". The cells will not accumulate around the nanopores on the sidewalls of the micro-channels, instead they will be driven down by the fluid and be collected from the end of the micro-channels. The accumulated cells will then form visible vertical bars, the lengths of which are proportional to the quantity of bacteria cells cultured under the different concentrations of the antibiotic.

A cell phone equipped with a macro-lens can then be used to photograph the "barcode" created by the AST. The image will be analysed automatically by the mobile app.

After the culture period, if all the "bars" of the cell sensor have similar lengths, it means the tested antibiotic cannot inhibit the growth of the bacteria, and thus the bacterial sample is resistant to the tested antibiotic. If the length of the "bars" is in general inversely proportional to the concentration of the antibiotic in the micro-channels, it shows that the tested antibiotic is generally effective at prohibiting the growth of the bacteria, and thus the bacteria is not drug-resistant. When two adjacent "bars" show a sharp difference in terms of length, it indicates that the antimicrobial effect of the antibiotic leaps when its concentration reaches a particular level.

The HKBU  research team tested E. coli and S. aureus with the "barcode" cell sensor and the results were consistent with those of the conventional AST. The test can be completed in three hours, which is much faster than the conventional AST. Microfluidic approaches developed by other researchers can also attain comparable speed, but they rely on expensive instruments for analysis in general. 

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Penn State Researchers Developing Genomic Resources to Identify Novel Pathogens

To enhance the early detection of novel infectious bacteria that could cause outbreaks of infectious disease and public health emergencies, a team of researchers in Penn State's College of Agricultural Sciences will sequence the genomes of 700 Bacilli bacteria — near relatives of the biothreat pathogen that causes anthrax.

Funded by a $1.2 million grant from the U.S. Centers for Disease Control and Prevention, the research will support the development of genomic resources and DNA sequence databases for the federal agency to increase its capacity for rapidly detecting novel pathogens, according to team leader Jasna Kovac, assistant professor of food science and Lester Earl and Veronica Casida Career Development Professor of Food Safety.

"You may have heard of the 2001 bioterrorist attacks in which spores of the bacteria Bacillus anthracis that cause anthrax were circulated in the mail," she said. "People who inhale these spores can get sick with anthrax, which is often fatal."

From a biodefense standpoint, it is important to understand the diversity of environmental Bacilli that could become novel biothreats such as anthrax, added Kovac, who has extensive experience with the genomics of Bacilli.

"There are known examples among Bacillus cereus group bacteria where 'benign' environmental strains have acquired anthrax-causing capabilities," she said. "We are interested in detecting and characterizing similar strains of Bacilli that have both the characteristics of known biothreats and harmless environmental microorganisms."

If emerging pathogens or biothreats are detected early on, they are more likely to be contained effectively to prevent a public health emergency, Kovac noted. "We are partnering with the CDC to create a large database of Bacilli to support its development of rapid laboratory methods for the detection of novel, naturally occurring or engineered pathogens and potential emerging biothreats," she said.

The databases will enhance and strengthen existing genomics approaches and bioinformatics pipelines developed by the CDC's Division of Preparedness and Emerging Infections group. This will allow for the rapid detection of genomic markers associated with increased biothreat risk, Kovac pointed out.

"We are uniquely positioned to complete the proposed work and support CDC's expansion of reference databases for the detection of novel, emerging infectious diseases," she said. "Here in Penn State's Department of Food Science, we have microbiology and genomic expertise and access to a large number of unique, environmental and food Bacilli, deposited in the Food Microbe Tracker culture collection and database curated by our collaborators at Cornell University."

Also on the research team are Xiaoyuan Wei, postdoctoral scholar; Taejung Chung, doctoral student; Jared Pavlock, research assistant; and Grant Harm, undergraduate research assistant.

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AAD, BARDA Partner to Seek Earlier Detection of Sepsis

AAD, developer of rapid diagnostic and data systems, announced that it has been awarded a federal contract for the development of an innovative system for the earlier detection of severe infection, including sepsis. The easy-to-use system is designed for use at point of care in urgent care clinics, doctors' offices and other prehospital settings, and could result in critical earlier intervention and improved patient outcomes.

AAD's QScout® RLD+ system is being developed as an easy-to-use, rapid-result hematology analyzer to capture a 7-part leukocyte differential, including quantification of band neutrophils and other immature granulocytes (IG). In serious infections, bands are released after mature neutrophils are depleted, and then IGs are released. Having automated band counts and the simultaneous availability of IG counts would be a first in medicine and will enable earlier identification of infection, including sepsis.

The QScout RLD+ system is designed to deliver laboratory-grade results in two minutes, in almost any setting, compared to the approximately two hours required of a traditional manual hospital testing procedure. Each hour delayed for the onset of antibiotic treatment of septic shock can increase mortality nearly 8%.

"According to the CDC, the vast majority of sepsis cases — 87 percent — begin outside of a hospital," said Joy Parr Drach, CEO of AAD. "Having a test system that in about two minutes can give results patient-side that are typically only available in a hospital setting would provide critical information and allow faster intervention for the patient. This new test system represents AAD doing things not before possible in places not before possible."

The development of AAD's new system is being funded in part with federal funds from the Biomedical Advanced Research and Development Authority's (BARDA) Division of Research, Innovation and Ventures under contract number 75A50121C00089; BARDA is part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.

According to the Centers for the Disease Prevention and Control (CDC), sepsis is a life-threatening medical emergency that happens when an infection a person already has triggers a chain reaction throughout the body. Infections that lead to sepsis most often start in the lung, urinary tract, skin, or gastrointestinal tract, although almost any infection can trigger sepsis, in which a localized infection progresses to severe infection throughout the body.

In a typical year, at least 1.7 million adults in the United States develop sepsis, and nearly 270,000 die as a result. A 2020 study estimated that sepsis caused approximately 11 million deaths worldwide in 2017 — or nearly 20 percent of all deaths in that year. Other studies show sepsis is the leading pediatric killer and leading cause of hospital deaths in the U.S.

About Advanced Animal Diagnostics

AAD (Advanced Animal Diagnostics) provides rapid point-of-care diagnostic and data systems for fast health care decisions. The company's QScout® line of rapid diagnostic tests empowers more precise care of animals and humans so they live healthier, more productive lives. Its diagnostic offerings inform real-time decisions that increase productivity, prevent losses, protect the food supply, and improve human and animal health well-being.

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New Device Can Diagnose COVID-19 From Saliva Samples

Engineers at MIT and Harvard University have designed a small tabletop device that can detect SARS-CoV-2 from a saliva sample in about an hour. In a new study, they showed that the diagnostic is just as accurate as the PCR tests now used.

The device can also be used to detect specific viral mutations linked to some of the SARS-CoV-2 variants that are now circulating. This result can also be obtained within an hour, potentially making it much easier to track different variants of the virus, especially in regions that don’t have access to genetic sequencing facilities.

“We demonstrated that our platform can be programmed to detect new variants that emerge, and that we could repurpose it quite quickly,” says James Collins, the Termeer Professor of Medical Engineering and Science in MIT’s Institute for Medical Engineering and Science (IMES) and Department of Biological Engineering. “In this study, we targeted the U.K., South African, and Brazilian variants, but you could readily adapt the diagnostic platform to address the Delta variant and other ones that are emerging.”

The new diagnostic, which relies on CRISPR technology, can be assembled for about $15, but those costs could come down significantly if the devices were produced at large scale, the researchers say.

Collins is the senior author of the new study, which appears in Science Advances. The paper’s lead authors are Helena de Puig, a postdoc at Harvard University’s Wyss Institute for Biologically Inspired Engineering; Rose Lee, an instructor in pediatrics at Boston Children’s Hospital and Beth Israel Deaconess Medical Center and a visiting fellow at the Wyss Institute; Devora Najjar, a graduate student in MIT’s Media Lab; and Xiao Tan, a clinical fellow at the Wyss Institute and an instructor in gastroenterology at Massachusetts General Hospital.

A self-contained diagnostic

The new diagnostic is based on SHERLOCK, a CRISPR-based tool that Collins and others first reported in 2017. Components of the system include an RNA guide strand that allows detection of specific target RNA sequences, and Cas enzymes that cleave those sequences and produce a fluorescent signal. All of these molecular components can be freeze-dried for long-term storage and reactivated upon exposure to water.

Last year, Collins’ lab began working on adapting this technology to detect the SARS-CoV-2 virus, hoping that they could design a diagnostic device that could yield rapid results and be operated with little or no expertise. They also wanted it to work with saliva samples, making it even easier for users.

To achieve that, the researchers had to incorporate a critical pre-processing step that disables enzymes called salivary nucleases, which destroy nucleic acids such as RNA. Once the sample goes into the device, the nucleases are inactivated by heat and two chemical reagents. Then, viral RNA is extracted and concentrated by passing the saliva through a membrane.

“That membrane was key to collecting the nucleic acids and concentrating them so that we can get the sensitivity that we are showing with this diagnostic,” Lee says.

This RNA sample is then exposed to freeze-dried CRISPR/Cas components, which are activated by automated puncturing of sealed water packets within the device. The one-pot reaction amplifies the RNA sample and then detects the target RNA sequence, if present.

“Our goal was to create an entirely self-contained diagnostic that requires no other equipment,” Tan says. “Essentially the patient spits into this device, and then you push down a plunger and you get an answer an hour later.”

The researchers designed the device, which they call minimally instrumented SHERLOCK (miSHERLOCK), so that it can have up to four modules that each look for a different target RNA sequence. The original module contains RNA guide strands that detect any strain of SARS-CoV-2. Other modules are specific to mutations associated with some of the variants that have arisen in the past year, including B.1.1.7, P.1, and B.1.351.

The Delta variant was not yet widespread when the researchers performed this study, but because the system is already built, they say it should be straightforward to design a new module to detect that variant. The system could also be easily programmed to monitor for new mutations that could make the virus more infectious.

“If you want to do more of a broad epidemiological survey, you can design assays before a mutation of concern appears in a population, to monitor for potentially dangerous mutations in the spike protein,” Najjar says.

Tracking variants

The researchers first tested their device with human saliva spiked with synthetic SARS-CoV-2 RNA sequences, and then with about 50 samples from patients who had tested positive for the virus. They found that the device was just as accurate as the gold standard PCR tests now used, which require nasal swabs and take more time and significantly more hardware and sample handling to yield results.

The device produces a fluorescent readout that can be seen with the naked eye, and the researchers also designed a smartphone app that can read the results and send them to public health departments for easier tracking.

The researchers believe their device could be produced at a cost as low as $2 to $3 per device. If approved by the FDA and manufactured at large scale, they envision that this kind of diagnostic could be useful either for people who want to be able to test at home, or in health care centers in areas without widespread access to PCR testing or genetic sequencing of SARS-CoV-2 variants.

“The ability to detect and track these variants is essential to effective public health, but unfortunately, variants are currently diagnosed only by nucleic acid sequencing at specialized epidemiological centers that are scarce even in resource-rich nations,” de Puig says.

Reference: de Puig H, Lee RA, Najjar D, et al. Minimally instrumented SHERLOCK (MiSHERLOCK) for CRISPR-based point-of-care diagnosis of SARS-CoV-2 and emerging variants. Sci Adv. 2021;7(32)

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Biosensors Transform the Diagnosis of Infections in Newborns

Sepsis refers to a systemic (body-wide) infection accompanied by inflammation. Newborn infants are particularly susceptible to developing sepsis, given their naïve and under-developed immune systems. The infant immune system reacts to the acquired pathogen by releasing inflammatory factors such as cytokines and free radicals. The heightened immune response mounted against the pathogen, if uncontrolled, can cause severe damage to other organs, which can be fatal for the newborn. The prevalence of neonatal sepsis and associated mortality rates are especially high in developing countries, owing to poor sanitation and the dearth of healthcare resources.

Early diagnosis is thus cardinal for effective management of the infection and decreasing neonatal mortality. Current point-of-care (POC) methods rely on conventional blood culture and molecular techniques that may be time-consuming and often detect a single parameter or biomarker. Hence, development of rapid, sensitive, and integrated diagnostic strategies is crucial to enhance detection and improve the standard of care.

In a new Clinica Chimica Acta article, researchers from Shoolini University, in collaboration with researchers from IIT Hyderabad and Amity University, Rajasthan, India, have reviewed the latest advancements in analytical devices that enable multi-analyte detection with high sensitivity and accuracy. They also describe the limitations of currently used methods and why a combinatorial approach may be better. Speaking of why this caught their attention, lead author of the study, Dr. Anupam Jyoti, says, "Developing countries like India report an increased incidence of neonatal sepsis (50–70/1000 live births) as compared to developed countries (1–5/1000 live births), with a substantial mortality rate of 11–19%. We were thus motivated to review the field of neonatal sepsis detection and propose new directions towards effective diagnosis."

Routinely used blood culture techniques often require two to five days to yield results. Meanwhile, the infection escalates, and the newborn is often pumped with unnecessary antibiotics that can lead to anti-microbial resistance. Techniques such as the polymerase chain reaction, which detects the genetic material of the pathogen, and mass spectrometry, which detects pathogen specific proteins, are more sensitive and require less time. However, they can yield false positive results and do not differentiate between viable and non-viable pathogens in the sample. While tests that detect serum biomarkers and immune factors, expressed in response to infection, may give a broad idea about the presence of sepsis, they cannot differentiate between specific pathogens. Together, the methods may however complement each other for robust diagnosis of sepsis.

Biosensing analytical technologies have emerged as a powerful tool in biomedical devices. Advanced biosensors that promise multi-analyte detection in a single platform are now being increasingly developed for rapid and sensitive diagnosis. Electrochemical sensors can detect various electrolytes and biomarkers based on their specific electrical properties. Given the minute size, stability and high binding affinity of aptamers, or single-stranded nucleic acid probes, are useful for detecting bacterial traces in the blood. Next, sensors based on the surface plasmon resonance technique can detect changes in the optical properties of the sample. They are highly sensitive with low limits of detection, thus enabling the detection of small concentrations of pathogens. Finally, microfluidic devices and chip-based sensors analyze samples based on their flow or size and can thus detect bacterial and blood cells in the samples of patients with sepsis.

In addition to these methods, integrated approaches that combine the principles of multiple techniques on a single platform are gaining popularity. Such hybrid biosensors will be capable of detecting multiple parameters in a short time from small samples at the bedside of the patient. Moreover, their wide applicability, cost-effectiveness, small size, and need for limited resources make them a practical and valuable tool for the diagnosis of neonatal sepsis.

Overall, the review sheds light on modern technologies that can help strengthen, and possibly replace conventional POC approaches in the future. "Integrated POC-based diagnosis will help reduce detection time considerably and thus translate diagnosis from bench to the bedside. An efficient POC sepsis diagnostic platform could expand health care access and impact populations worldwide," says Dr. Jyoti.

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Microwave Sensor for Rapid Antibiotic Sensitivity Testing

Researchers on the campus of the University of British Columbia Okanagan have developed a portable and economical microwave sensor that can quickly detect changes in bacterial growth to assess susceptibility to antibiotics. Using a split ring microwave resonator, the device can very significantly measure bacterial growth in the presence of different concentrations of antibiotic before there are visible changes in growth. The technology reduces the time and costs associated with these tests and could pave the way for personalized antibiotic therapy for regions with low or remote resources.

Antibiotics have revolutionized healthcare, allowing routine surgical procedures to continue without the excessive fear of devastating infections and ending a huge variety of nasty diseases that would previously have killed or disabled millions of people each year. . However, these advances are being eliminated slowly but surely by antibiotic resistance, which increases every year.

“Many types of bacteria are constantly evolving to develop antibiotic resistance. This is an urgent issue for hospitals around the world, while diagnostic and sensor technology has been slow to adapt, “Mohammad Zarifi, a researcher involved in the study, said in a press release.

The main problem is the inappropriate use of antibiotics and part of the solution is to choose the right antibiotic for each patient. After all, it is useless to prescribe an antibacterial agent for an infection caused by bacteria that are already resistant to that agent. This is where personalized antibiotic therapy comes in, which is to test a sample of disease-causing bacteria for a specific patient to determine their antibiotic susceptibility before prescribing a suitable antibiotic.

The problem is that this process is time consuming and expensive, often taking 48 hours, which is no joke if you have a serious infection. “Longer waiting times can significantly delay the treatments patients receive, which can lead to medical or even fatal complications. This method demonstrates the requirement for a reliable, fast and cost-effective screening tool,” he said. Zarifi.

This new technology is based on the detection of microwaves as a means to control the growth of the bacterial sample in the presence of different concentrations of antibiotic. The system is sensitive enough that it can detect differences in bacterial growth that are invisible to the human eye, and achieves this through a split-ring microwave resonator. The charged substances released by bacterial cells, when affected by antibiotics, can help with the measurement, but in essence, the resonant response of the split ring is affected by the growth of a bacterial sample on agar.

Ultimately, researchers hope to incorporate an element of artificial intelligence into the technology to help detect and predict personalized antibiotic treatment.

“Our ultimate goal is to reduce the inappropriate use of antibiotics and improve the quality of patient care,” Zarifi said. “The more quality tools health professionals have at their disposal, the greater their ability to fight bacteria and viruses.”

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Using Two CRISPR Enzymes, UC Berkeley Scientists Develop a 20-Minute COVID Diagnostic

While today’s gold standard COVID-19 diagnostic test, which uses qRT-PCR — quantitative reverse-transcriptase-polymerase chain reaction (PCR) — is extremely sensitive, detecting down to one copy of RNA per microliter, it requires specialized equipment, a runtime of several hours and a centralized laboratory facility. As a result, testing typically takes at least one to two days.

A research team led by scientists in the labs of Jennifer Doudna, David Savage and Patrick Hsu at the University of California, Berkeley, is aiming to develop a diagnostic test that is much faster and easier to deploy than qRT-PCR. It has now combined two different types of CRISPR enzymes to create an assay that can detect small amounts of viral RNA in less than an hour. Doudna shared the 2020 Nobel Prize in Chemistry for invention of CRISPR-Cas9 genome editing.

While the new technique is not yet at the stage where it rivals the sensitivity of qRT-PCR, which can detect just a few copies of the virus per microliter of liquid, it is already able to pick up levels of viral RNA — about 30 copies per microliter — sufficient to be used to surveil the population and limit the spread of infections.

“You don’t need the sensitivity of PCR to basically catch and diagnose COVID-19 in the community, if the test’s convenient enough and fast enough,” said co-author David Savage, professor of molecular and cell biology. “Our hope was to drive the biochemistry as far as possible to the point where you could imagine a very convenient format in a setting where you can get tested every day, say, at the entrance to work.”

The researchers will report their results online August 5 in the journal Nature Chemical Biology.

Several CRISPR-based assays have been authorized for emergency use by the Food and Drug Administration, but all require an initial step in which the viral RNA is amplified so that the detection signal — which involves release of a fluorescent molecule that glows under blue light — is bright enough to see. While this initial amplification increases the test’s sensitivity to a similar level as qRT-PCR, it also introduces steps that make the test more difficult to carry out outside of a laboratory.

The UC Berkeley-led team sought to reach a useful sensitivity and speed without sacrificing the simplicity of the assay.

“For point of care applications, you want to have a rapid response so that people can quickly know if they’re infected or not, before you get on a flight, for example, or go visit relatives,” said team leader Tina Liu, a research scientist in Doudna’s lab at the Innovative Genomics Institute (IGI), a CRISPR-focused center involving UC Berkeley and UC San Francisco scientists.

Aside from having an added step, another disadvantage of initial amplification is that, because it makes billions of copies of viral RNA, there is a greater chance of cross-contamination across patient samples. The new technique developed by the team flips this around and instead boosts the fluorescent signal, eliminating a major source of cross-contamination.

The amplification-free technique, which they term Fast Integrated Nuclease Detection In Tandem (FIND-IT), could enable quick and inexpensive diagnostic tests for many other infectious diseases.

“While we did start this project for the express purpose of impacting COVID-19, I think this particular technique could be applicable to more than just this pandemic because, ultimately, CRISPR is programable,” Liu said. “So, you could load the CRISPR enzyme with a sequence targeting flu virus or HIV virus or any type of RNA virus, and the system has the potential to work in the same way. This paper really establishes that this biochemistry is a simpler way to detect RNA and has the capability to detect that RNA in a sensitive and fast time frame that could be amenable for future applications in point of care diagnostics.”

The researchers are currently in the process of building such a diagnostic using FIND-IT, which would include steps to collect and process samples and to run the assay on a compact microfluidic device.

Employing tandem Cas proteins

To remove target amplification from the equation, the team employed a CRISPR enzyme — Cas13 — to first detect the viral RNA, and another type of Cas protein, called Csm6, to amplify the fluorescence signal.

Cas13 is a general purpose scissors for cutting RNA; once it binds to its target sequence, specified by a guide RNA, it is primed to cut a broad range of other RNA molecules. This target-triggered cutting activity can be harnessed to couple detection of a specific RNA sequence to release of a fluorescent reporter molecule. However, on its own, Cas13 can require hours to generate a detectable signal when very low amounts of target RNA are present.

Liu’s insight was to use Csm6 to amplify the effect of Cas13. Csm6 is a CRISPR enzyme that senses the presence of small rings of RNA and becomes activated to cut a broad range of RNA molecules in cells.

To boost Cas13 detection, she and her colleagues designed a specially engineered activator molecule that gets cut when Cas13 detects viral RNA. A fragment of this molecule can bind to and trigger Csm6 to cut and release a bright fluorescent molecule from a piece of RNA. Normally, the activator molecule is quickly broken down by Csm6, thus limiting the amount of fluorescent signal it can generate. Liu and her colleagues devised a way to chemically modify the activator so that it is protected from degradation and can supercharge Csm6 to repeatedly cut and release fluorescent molecules linked to RNA. This results in a sensitivity that is 100 times better than the original activator.

“When Cas13 gets activated, it cleaves this small activator, removing a segment that protects it,” Liu said. “Now that it’s liberated, it can activate lots of different molecules of that second enzyme, Csm6. And so, one target recognized by Cas13 doesn’t just lead to activation of its own RNA-cutting ability; it leads to the generation of many more active enzymes that can each then cleave even more fluorescent reporters.”

The team of researchers also incorporated an optimized combination of guide RNAs that enables more sensitive recognition of the viral RNA by Cas13. When this was combined with Csm6 and its activator, the team was able to detect down to 31 copies per microliter of SARS-CoV-2 RNA in as little as 20 minutes.

The researchers also added extracted RNA from patient samples to the FIND-IT assay in a microfluidic cartridge, to see if this assay could be adapted to run on a portable device. Using a small device with a camera, they could detect SARS-CoV-2 RNA extracted from patient samples at a sensitivity that would capture COVID-19 infections at their peak.

“This tandem nuclease approach — Cas13 plus Csm6 — combines everything into a single reaction at a single temperature, 37 degrees Celsius, so it does not require high temperature heating or multiple steps, as is necessary for other diagnostic techniques,” Liu said. “I think this opens up opportunities for faster, simpler tests that can reach a comparable sensitivity to other current techniques and could potentially reach even higher sensitivities in the future.”

The development of this amplification-free method for RNA detection resulted from a reorientation of research within IGI when the pandemic began toward problems of COVID-19 diagnosis and treatment. Ultimately, five labs at UC Berkeley and two labs at UCSF became involved in this research project, one of many within the IGI.

“When we started this, we had hopes of creating something that reached parity with PCR, but didn’t require amplification — that would be the dream,” said Savage, who was principal investigator for the project. “And from a sensitivity perspective, we had about a ten thousandfold gap to jump. We’ve made it about a thousandfold; we’ve driven it down about three orders of magnitude. So, we’re almost there. Last April, when we were really starting to map it out, that seemed almost impossible.”

The work was supported by the Defense Advanced Research Projects Agency (N66001-20-2-4033). Co-authors of the paper include members of the labs of Jennifer Doudna, David Savage, Patrick Hsu, Liana Lareau and Daniel Fletcher at UC Berkeley; Gavin Knott at Monash University in Australia; Melanie Ott and Katherine Pollard at Gladstone Institutes and UCSF; and Ming Tan at Wainamics, a research and development firm in Pleasanton, California, that produces microfluidic devices. Doudna, IGI’s founder and currently president and chair of the IGI governance board, is the Li Ka Shing Chancellor’s Chair at UC Berkeley and a professor of chemistry and of molecular and cell biology. Hsu, Lareau and Fletcher are faculty in the Department of Bioengineering.

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Immunexpress Announces SeptiCyte® RAPID Testing For Paediatric Sepsis

Immunexpress, Pty Ltd, a molecular diagnostic company founded in Brisbane, today announced that the SeptiCyte® RAPID test will be evaluated in the diagnosis of paediatric sepsis in Queensland children. 

The testing is in part funded through a Federal Government's Medical Research Future Fund Genomic Health Futures Mission grant for collaborative work between The University of Queensland and Immunexpress. One of the keys to the successful development of the SeptiCyte technology has been early investment funding through the foresight of Brian Flannery (Ilwella family office), and Australian Federal Government commercialization grants.

The work will be led by the paediatric sepsis research team working with Associate Professor Luregn Schlapbach (Child Health Research Centre - The University of Queensland) and Dr. Richard Brandon (co-founder and Chief Scientific Officer of Immunexpress) and will involve SeptiCyte® RAPID testing on a near-patient testing platform (Biocartis Idylla™).  From a small blood sample, and within approximately one hour, SeptiCyte® RAPID provides a probability of sepsis in children presenting with clinical signs of systemic inflammation, such as fever or rapid breathing. 

"Immunexpress was founded in Queensland and now SeptiCyte technology is coming home," said Dr. Brandon. "SeptiCyte LAB was FDA cleared for use in adults, while the fully automated 2nd generation product, SeptiCyte RAPID is CE marked and it is now important that we demonstrate clinical utility of SeptiCyte RAPID in children. Our collaboration with The University of Queensland is providing us with this opportunity."

Associate Professor Schlapbach said, "The results of the collaborative work will help save the lives of critically-ill children by improving diagnosis of sepsis using genomic technology. Early and accurate diagnosis of sepsis is crucial in successful management of these patients." Sepsis remains a leading cause of mortality in children worldwide. 

About SeptiCyte® RAPID

SeptiCyte® RAPID is a gene expression assay discovered and patented from Australia, which uses reverse transcription polymerase chain reaction (PCR) to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene® Blood RNA Tube. SeptiCyte® RAPID is used in conjunction with clinical assessments, vital signs and laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis. SeptiCyte® RAPID generates a score (SeptiScore®) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte® RAPID is intended for in-vitro diagnostic use and is used on the Biocartis Idylla™ System.

SeptiCyte® RAPID is CE Marked as a near-patient sample-to-answer test in European Union (EU) member countries and those harmonized with the EU IVD Directive (98/79/EC).  SeptiCyte® LAB was FDA cleared in 2019.  Australian TGA registration is expected later in 2021.

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Diagnostics Startup ID Genomics Receives NIH Grant to Develop Rapid Test for COVID-19 Variants

Diagnostics startup ID Genomics will accelerate its development of a quick test for variants of the COVID-19 virus with a new grant from the U.S. National Institutes of Health.

The Seattle-based company announced the $300,000 small business grant Tuesday for the dipstick-based test, currently dubbed CovNET. ID Genomics is also eligible for a follow-on grant of up to $3 million.

Most tests for the virus simply provide a ‘yes’ or ‘no’ answer to whether someone is infected. ID Genomics’ prototype test can also distinguish which variant an individual is infected with, and it can do so within two hours.

That’s faster than the gold-standard method, which involves sequencing the genome of the virus to detect variants. Some existing rapid tests can also pick up a single variant or a few, but CovNET stands out by distinguishing among dozens, according to ID Genomics’ co-founder Evgeni Sokurenko.

Sokurenko co-founded ID Genomics in 2014 with the goal of combining epidemiological surveillance, bioinformatics and molecular diagnostics. The 6-person company provides a variety of services to identify different microbes and their subtypes.

In addition to developing the CovNET rapid test, ID Genomics will launch a next-day sequencing service for variants within the next few weeks. The researchers showcased their sequencing approach in a recent study of a variant that emerged in California.

But the new two-hour test could ultimately be easier to deploy and potentially cheaper, aiding “real-time” monitoring of current and emerging variants, said Sokurenko, who is also a professor of microbiology at the University of Washington. The UW is the academic partner on the grant.

Sokurenko said that easy detection of variants could “help with close monitoring of pandemic dynamics, viral evolution and spread as well as timely detection and containment of local outbreaks.” In addition, better detection could support the development of treatments tailored to each version of the virus.

New variants are continually emerging, and the highly contagious delta variant is now dominant in the U.S. and many other countries. The World Health Organization has identified three other ‘Variants of Concern.’ These variants are known to be nastier than the original version of the virus, for instance transmitting more easily or making people sicker.

ID Genomics aims for an easy-to-use test that could be rapidly deployed across epidemiological surveillance labs globally. “With all stars aligned, we might start selling the test kit within months,” said Sokurenko of CovNET. “Affordability is the goal,” he added.

The prototype CovNET test uses a technique called PCR to identify variants, which show up as bands on a strip. The location and intensity of the bands can identify the predominant variant in a sample. Each double-sided strip can identify up to 24 variants and using more strips enables detection of more variants.

The company is also developing a smartphone app to rapidly decode the bands and identify which variant they correspond to.

CovNET adapts components of technology built by Bothell, Wash.-based IEH laboratories for other types of tests. IEH Laboratories is also collaborating with ID Genomics to a develop a pocket-size “nanocycler” to incubate the samples. The battery-powered device is capable of the rapid cycles of heating and cooling in the PCR portion of the test, which amplifies the genetic material of the virus.

The new grant will enable the startup to optimize the prototype test and validate it on a large number of clinical samples. ID Genomics is also working on agreements for manufacturing and distribution.

There is a growing pool of diagnostic tests for COVID-19, many tracked by Seattle-based PATH. New tests include a home-based PCR test to detect the virus from Amazon, and a test that can also tell if you’ve been infected with the virus in the past, developed by Seattle-based Adaptive Biotechnologies in partnership with Microsoft.

But there is a need for tests that can enable more efficient surveillance of variants. Washington state is currently sequencing close to 20% of virus samples for variants, but that is more than most states and many national labs.

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Sense Biodetection Raises Funding Toward Developing a New COVID-19 Test

Sense Biodetection has completed a $50 million Series B financing, with the molecular diagnostics company saying it will use the proceeds to accelerate the launch of its Veros COVID-19 test, and further develop a portfolio of instrument-free, rapid molecular tests.

Those tests will be based on Sense’s Veros platform, which is designed to detect a variety of deadly and costly diseases by applying rapid molecular amplification technology.

The platform is intended to underpin a new class of rapid molecular diagnostic tests that emulate the performance of central laboratory PCR testing, but are disposable and easy-to-use since they do not need an accompanying instrument or reader.

As a result, Sense says, Veros diagnostics can be used beyond traditional healthcare settings–enabling better access, outcomes, and value for patients and providers.

Sense’s technology is based on isothermal amplification and non-fluorescent color detection of amplified analytes on an easy-to-use device.

“This Series B round is crucial in providing us with the resources to grow our Veros platform to revolutionize decentralized point-of-care testing, and it is particularly important as we commercialize our Veros COVID-19 test,” Sense CEO Harry Lamble said Tuesday in a statement.

Koch Disruptive Technologies (KDT), a subsidiary of Koch Industries, led the Series B financing, with participation from Sense’s existing investors Cambridge Innovation Capital, Earlybird Health, Jonathan Milner and Mercia Asset Management.

Based in Abingdon, U.K., Sense was founded in 2014. Five years later, it raised £12.3 million ($17.2 million) in Series A financing, with the proceeds intended toward test development.

Koch Industries operates in more than 70 countries and generates $115 billion in revenue, making it one of the largest privately-held companies in the world.

“KDT sees huge potential for Sense’s Veros platform to transform the way medical providers and patients approach healthcare, empowering more choice, increased access, and better quality of care,” stated KDT President Chase Koch. “Sense’s talented team and its innovative Veros platform are changing the way we manage healthcare and infectious diseases, and we expect even greater applications of their technology as they continue to grow.”

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Israeli Company Develops Faster, More Comprehensive Tuberculosis Test

Israeli tech company BATM Advanced Communications Ltd. announced on Monday that they have received full funding to develop a new rapid molecular diagnostics test for Tuberculosis (TB), which is expected to begin its testing and validation phases in the second half of 2021.

The testing and validation phases will be fully funded by Stop TB Partnership, an international alliance which is comprised of over governmental and non-governmental organisations in more than 100 countries, all dedicated to eliminating the disease.

While current gold standard tests take days to return results and have issues determining antibiotic resistance, BATM's new test returns results within approximately two hours, identifying the strain and its resistance to antibiotics. 

It does this using a combination of a one-step PCR test, developed by BATM subsidiary Adaltis, with a NATlab instrument, which uses a new isothermal RCA process developed by BATM's associate company, Ador Diagnostics. 

The testing and validation of the test will take place at the University of Heidelberg, with BATM anticipating it will officially begin selling them next year.

BATM CEO Dr. Zvi Marom said the company was delighted about the new testing method and the funding and research announcements, saying they believe it "will be particularly crucial in preventing the spread of drug-resistant TB strains." 

"We also expect our solution to be more affordable and accessible than those used today," he said.

Dr. Marom elaborated, saying that "The devastating health, social and economic consequences of TB have been with us for centuries and are still here today. It is vital that we develop innovative solutions and systems that will enable this disease, which is a leading cause of death but is both preventable and curable, to be eradicated." 

He said that advances in molecular diagnostics have caused science to enter "a new era in the fight against infectious diseases." 

"I believe that BATM has an important role to play in this as we focus on developing new, innovative technologies while continuing to provide critical solutions to combat COVID-19," he concluded.

TB is one of the top 10 causes of death worldwide and the leading (non-pandemic) cause from a single infectious agent The WHO estimates that around three million cases go undiagnosed each year.

Drug-resistance, which can emerge through the prescription of incorrect treatment, in TB is an increasing public health issue and a health security threat.  TB can also cause other severe illnesses, such as meningitis, and can be an early indicator for HIV infection.

However, "with rapid and accurate diagnosis," BATM says, "TB is preventable, treatable and curable in most cases."

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MatMaCorp Launches MYRTA, a New Hand-Held Real-Time PCR Device for POC and OTC Molecular Diagnostics

MatMaCorp (Materials and Machines Corporation), a developer of comprehensive molecular diagnostic systems, today announced the launch of its new hand-held device capable of conducting polymerase chain reaction (PCR) amplification and real-time fluorescent detection, anytime, anywhere. The device, called MYRTA™ (MY Real-Time Analyzer) was developed to provide portable, PCR-based molecular diagnostic solutions for human and animal health.

“The COVID-19 pandemic has highlighted the substantial need for over-the-counter and point-of-care testing to detect viruses, like SARS-CoV-2, and other disease-causing agents, at any time and any location in the world,” said Dr. Abe Oommen, MatMaCorp founder and President. “Almost all of the current handheld molecular diagnostic solutions have focused on isothermal amplification methods, but real-time PCR is still the gold standard for diagnostics that require high sensitivity and specificity.”

Real-time PCR is the primary method to reliably detect active infection of SARS-CoV-2 (the coronavirus that causes COVID-19) in patient samples. Efforts at developing easy-to-use and affordable over-the-counter (OTC) and point-of-care (POC) devices have been constrained by the fact that RNA or DNA isolation from samples must be integrated into the PCR amplification and detection steps. This has resulted in PCR-based methods for OTC and POC devices being side-lined, regardless of the fact that real-time PCR is the benchmark by which other molecular tests are measured. MatMaCorp successfully overcame these issues in the development of MYRTA, which can simultaneously conduct PCR amplification and rapid, real-time fluorescence detection.

“The ability to detect nucleic acids in real-time while running PCR amplification directly from the sample is a game changer in molecular diagnostics,” said Dr. Oommen. “Our flexible, robust, and portable MYRTA device will enable the use of PCR in numerous situations, making point-of-care and over-the-counter PCR-based testing possible in any part of the globe. Remote hospitals and clinics, as well as the military, can use this device to monitor disease causing pathogens.”

MatMaCorp has demonstrated accurate detection of SARS-CoV-2 and influenza A and B viruses directly from samples. In addition to human health applications, the MYRTA system could also be used in animal health, as shown by its ability to detect porcine reproductive and respiratory syndrome virus (PRRSV), a virus that causes major respiratory disease in pigs.

MatMaCorp plans to submit the MYRTA system to the U.S. Food and Drug Administration’s (FDA) for consideration of Emergency Use Authorization (EUA) for COVID-19 in the coming months. The FDA previously granted EUA to MatMaCorp’s COVID-19 2SF RNA test for the detection of SARS-CoV-2 on the company’s Solas 8 portable detection system.

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binx health Receives FDA CLIA Waiver for Chlamydia and Gonorrhea Test

binx health, a population health technology company that provides convenient healthcare solutions, announced today that the US Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA) waiver for the binx io system, a first-of-its kind molecular point-of-care testing platform capable of delivering central laboratory quality results in about 30 minutes, for the detection of chlamydia (CT) and gonorrhea (NG). The platform was previously 510(k) cleared by the FDA for testing male and female samples in moderate and high-complexity locations.

"With ever increasing sexually transmitted infection (STI) rates, point-of-care and CLIA-waived platforms like the binx io are essential additions to our STI control toolbox, which will increase accessibility and decrease the burden on traditional healthcare settings," said Barbara Van Der Pol, PhD, MPH, Professor of Medicine and Public Health at University of Alabama at Birmingham.

CLIA waiver clearance allows binx to facilitate single visit testing for CT/NG in any of the more than 220,000 locations across the Unites States holding a CLIA certificate of waiver, including convenient and accessible locations such as OBGYN and primary care offices, urgent care facilities, community health clinics, STD clinics and retail settings. Single-visit diagnosis and treatment have the potential to improve treatment compliance and reduce STI transmission across communities.

"Clinicians on the front lines of sexual health and wellness have long needed options for rapid diagnostic tools to address the epidemic growth in STIs. In a healthcare landscape where consumer convenience and rapid answers are an imperative, the binx io is the first chlamydia and gonorrhea test to be used in near patient settings combining the features essential to meet these needs in a critically important area of sexual health," said Jeffrey Luber, binx Chief Executive Officer. "The io Instrument's demonstrated clinical effectiveness, ease of operation, and patient convenience make it a much-needed tool with transformative implications for public health, especially now during the COVID-19 pandemic where STI prevention services nationwide have been dramatically reduced or cut altogether as resources have been allocated to focus on the COVID response. We are grateful to the countless scientists, physicians, and key opinion leaders who played an important role in today's watershed event."

The CDC estimates that 1 in 5 people in the U.S.1 have an STI; based on CDC and USPSTF guidelines There are an estimated 108M people in the United States, for whom regular STI testing is appropriate.2 3

Today, nearly all CT/NG tests are processed at central laboratories, with a delay between diagnoses and treatment in many cases of several days or more, which often results in infected patients not returning for treatment. Data show that treatment delays may lead to onward transmission and serious health consequences particularly in women, with 10-15% of un-treated women experiencing Pelvic Inflammatory Disease and nearly 30,000 cases of infertility annually in the US related to undetected chlamydia4. Due to these delays, and potentially detrimental follow-on health effects, published data5 also show that clinicians are more likely to presumptively treat symptomatic patients with antibiotics while the patient is in the clinic rather than wait for central laboratory test results. Inappropriate antibiotic treatment can promote antimicrobial resistance and can contribute to the onward transmission of the untreated infection.

The CLIA waived status allows for expansion by permitting the binx io, through its national commercial distribution partnership with McKesson, to be placed in the over 220,000 CLIA-waived locations nationwide.

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IIT Delhi Develops Handheld Device For Early And Rapid Diagnosis Of Dengue

Dengue is a serious global health concern with a large population around the world facing the risk of getting infected. Early diagnosis of dengue is the key to prevent deterioration of a patient’s health. However, conventional diagnostic tools like nucleic acid detection using Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a time taking proess and it also requires expensive equipments and reagents for the diagnosis of dengue.

These types of common diseases require a rapid, scalable and point-of-care diagnosis to be implemented at the community level and to reduce the workload of healthcare professionals. Understanding this, the GLancing Angle Deposition (GLAD) research group at IIT Delhi’s Physics Department has developed a handheld Surface Enhanced Raman Spectroscopy (SERS) based platform for early diagnosis of dengue virus. It also gives dengue test results within one hour (rapid diagnosis).

The handheld device has been succsessfully tested on the clinical blood samples collected from hundreds of individuals in collaboration with ICMR-National Institute of Malaria Research (NIMR), New Delhi.

Principal Investigator of the project and Professor in the Department of Physics, IIT Delhi, Prof. J.P. Singh’s research group is known for the synthesis of nanoscultptured thin films using a specialized technique called GLAD. This technique was employed to fabricate silver nanorods array based SERS active biosensors in order to detect pathogens. Only 2 microlitres of a diluted serum was dropcasted on the SERS substartes and Raman spectra were collected by flashing 785 nm laser beam through the device. All the data were fed in a statistical tool principal component analyzer (PCA) software. The intergrated device was able to clearly differentiate the three sets of blood samples; dengue positive, negative and healthy. This method provides a sensitive, rapid, and field deployable diagnosis of dengue at the early stage.

The research work was funded by IMPRINT India program of the Ministry of Education with New Age Instruments and Materials Pvt Ltd as the industry partner. The research was published in the journal Analytical Chemistry 92, 2527-2534 (2020).

The detection and distinction of human immunodeficiency virus (HIV-1) was also carried out in collaboration with ICMR-National AIDS Research Institute (NARI), Pune through the handheld SERS based platform. Binding of viruses directly on Ag nanorods without using antibodies or intermediate reagents was successfully demonstrated. The SERS platform was capable of distinguishing different tropic strains of HIV-1 suggesting tropism-based detection. The SERS based platform gives HIV-1 test results within an hour.

Speaking of the hand-held device, the project’s PI, Prof. J.P. Singh, IIT Delhi said, “This ultrasensitive and handy device has wide range of applications in the early-stage on-site detection of viral diseases and can produce the final report of investigation within an hour.” The research work was published recently in journal Colloids and Surfaces B: Biointerfaces 198, 111477 (2021). 

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Ultra-sensitive and Rapid Diagnostic Developed to Detect Ebola

An interdisciplinary team of scientists at Duke University has developed a highly sensitive and rapid diagnostic test for Ebola virus (EBOV) infection. In monkeys infected with Ebola, this diagnostic, called the D4-assay, proved to be 1000 times more sensitive than the currently approved rapid diagnostic test and capable of detecting the virus a full day earlier than the gold standard polymerase chain reaction (PCR) test.

This work, which appears in Science Translational Medicine on April 7, was done by biomedical engineers, molecular biologists, and immunologists at Duke University, and the University of Texas Medical Branch in Galveston and the Galveston National Laboratory.

Ebola virus gained global notoriety in early 2014 after an outbreak began spreading across the populous capital cities in Guinea, Liberia and Sierra Leone in Western Africa. By the time the pandemic was officially declared ended in 2016, more than 28,000 people had been infected and more than 11,300 people had died of the virus.

As of March 2021, there are two ongoing Ebola outbreaks in the Democratic Republic of the Congo that have resulted in more than 2,200 deaths, and Guinea declared a new outbreak of Ebola virus disease (EVD) after a cluster of cases appeared in February.

Early treatment and contact tracing of Ebola virus disease is critical for two reasons: First, patients are highly contagious once they begin showing symptoms, and early diagnosis can help contain the spread of EVD by make contact tracing and patient isolation easier. Second, the fatality rate of EVD can be as high as 90 percent if left untreated or treated late, but can be reduced to roughly 10 percent with monoclonal antibodies if patients are treated early in the infection.

The current gold standard for detecting Ebola virus is the reverse transcriptase polymerase chain reaction (RT-PCR) test, which identifies and amplifies viral RNA. Although RT-PCR has proven to be sensitive and capable of diagnosing Ebola infection much earlier than current alternatives, it has been difficult to implement in the remote settings where EVD outbreaks frequently originate.

Recent advances in RT-PCR test design have made it easier for untrained technicians to use the platform and reduced the need for expensive equipment. However, at $22.50 per test, the platform is expensive and, because it is lab-based, can be slow. In some studies, the median time required to confirm a diagnosis in the field is 6 days, making it a suboptimal tool when dealing with a highly contagious virus.

The current alternate diagnostic option is lateral flow assays, which detect antibodies or antigens that appear during an infection. These tests are cheaper, easy to use, and typically yield results in less than 30 minutes, but the trade-off is a greatly diminished sensitivity, so there is a greater possibility of the test missing an early infection.

To help address the shortcomings of both tests, the Duke team adapted the D4 assay, an ultrasensitive, point-of-care diagnostic previously developed by the Ahsutosh Chilkoti lab, to quickly and accurately detect secreted glycoprotein (sGP), a biomarker produced by the Ebola virus during the early stages of infection.

Besides Chilkoti, the Alan L. Kaganov Distinguished Professor of Biomedical Engineering, the team included Cassio Fontes, a former graduate student and now a senior research scientist in the Chilkoti lab, Michael Gunn, MD, a professor of medicine and immunology, and Barbara Lipes, an assistant professor of medicine at the Duke University School of Medicine.

"Prior studies suggested that Ebola virus produces secreted glycoprotein at high levels early in infection to act as a decoy and distract the immune system while the virus replicates and binds to the host cells," Fontes said. "We thought that if we could detect that, we could help facilitate earlier diagnosis, containment, and treatment during Ebola outbreak."

However, antibodies against sGP were not available, so Lipes, an antibody engineering expert in the Gunn lab, created a large library of antibodies that bind to sGP and screened for the antibodies that bound most strongly.

The two labs then worked together to identify the capture-detection antibody pair that provided the greatest sensitivity on the D4 platform.

The D4 assay for Ebola is made by inkjet printing these two antibodies against secreted glycoprotein onto a glass slide: detection antibodies, which are tagged with a fluorescent marker, and capture antibodies, which are primed to bind the target antigen. When a drop of blood or a throat or nose swab is placed on the slide, the detection antibodies separate from the array and bind to the target in the sample. These antibody-biomarker complexes then attach to the capture antibodies on the slide, which glow to indicate a capture.

To further improve sensitivity, the D4 assay is printed on a stealth polymer brush coating developed by the Chilkoti lab, which prevents non-target proteins from attaching to the slide's surface. This removes any 'background noise' on the chip, making it easier to detect very low levels of the target proteins, which makes the D4 assay very sensitive.

In parallel, the Chilkoti lab also developed a cheap but highly sensitive hand-held detector -- the D4Scope -- to read the results of the D4 assay.

"Jason Liu, a graduate student in my lab, worked to develop the D4Scope, which is a low-cost, battery-powered, compact, wide-field fluorescence reader that can image microarray spots with high sensitivity," Chilkoti said. "It was specifically designed using off-the-shelf components, so that parts could easily be replaced if the reader was damaged in the field."

To test their platform, the team worked with collaborators at the University of Texas Medical Branch in Galveston, where they showed that the D4 assay could detect EBOV in non-human primates a full day earlier than the RT-PCR.

"We've put the lateral flow assay to shame, sensitivity wise," said Fontes. "This is exciting because by understanding the biology of this virus, we've shown that there may be a target to look for where immunoassays like the D4 can outperform the PCR. It's really breaking new ground."

As the team moves forward, they aim to continue to refine their platform with the goal of shortening the time to results from 60 minutes to 30 minutes. Experiments are underway using molecular evolution to increase the sensitivity of the capture and detection antibodies.

They are also improving the design of the platform to make it a fully self-contained test. This would mean that users would only need to add a drop of blood to one port of a flow cell and a buffer solution to a second port to run the test under gravity flow. These changes would also allow for improved biocontainment and biosafety when handling potentially dangerous fluids.

Once these changes are made, the team hopes to coordinate clinical experiments in the field.

"I think it's a tremendous opportunity to really change the way Ebola testing works," Gunn said.

"When controlling an outbreak, it's key to identify the infected and be able to trace their contacts very quickly, and our hope is that test would allow you to do that," Gunn said. "With such a simple and rapid assay, you can also quickly screen people who are at risk of having contracted Ebola. It seems simple, but in the grand scheme of things could represent the difference between an outbreak and a pandemic."

This research was funded by the National Institutes of Health (NIH, R01AI150888; U19AI142785; UC7AI094660), the US Special Operations Command (w81XWH- 16C-0219), the National Council for the Improvement of Higher Education and the Science Without Borders project. Partial support was provided by the Department of Health and Human Services. The team also received the support of the Biosafety Level 4 (BSL-4) lab at the Galveston National Laboratory.

Competing Interests: The underlying technology of the D4 was developed by Angus Hucknall and Ashutosh Chilkoti, and was acquired by Immucor Inc (Norcross, GA) in 2014. The other authors declare no competing financial interests.

REFERENCE

"Ultrasensitive Point-Of-Care Immunoassay for Secreted Glycoprotein Detects Ebola Infection Earlier Than PCR," Cassio Fontes, Barbara Lipes, Jason Liu, Krystle Agans, Aiwei Yan, Patricia Shi, Daniela Cruz, Garrett Kelly, Kelli Luginbuhl, Daniel Joh, Stephanie Foster, Jacob Heggestad, Angus Hucknall, Maiken Mikkelson, Carl Pieper, Roarke Horstmeyer, Thomas Geisbert, Michael Gunn, Ashutosh Chilkoti. Science Translational Medicine, April 7, 2021. DOI 10.1126/scitranslmed.abd9696

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Microtox® BT Evaluation of SARS-CoV-2 from Breath Test with Clinical Samples

DeepVerge, the environmental and life science AI company, announces initial data for ongoing Phase III clinical studies on the detection of SARS-CoV-2 on breath samples and identification of confirmed COVID19 positive patients.

Since Q3 2020, DeepVerge scientists have been working under laboratory conditions with the Spike Protein (“S-Protein”) of SARS-CoV-2 on the SARS-CoV-2 virus inside the Containment Level 3 (“CL3”) laboratories at the University of Aberdeen. In these studies, they have detected and identified the virus S-Protein in quantities at 40 femtogrami per millilitre (“Fg/mL”) at close to 100% sensitivity and specificity on DeepVerge’s Microtox® BTii nano-optofluidic chip.

In addition, under the clinical trial supervision of the Royal College of Surgeons, Ireland, 40 subjects, 16 of which were independently confirmed as COVID19 positive with PCRiii tests, provided breath samples that were tested on the Microtox® BT nano-optofluidic chip surface with Affimer® reagents (“Avacta Group”)iv and Optimers (“Aptamer Group”)v together the (“Binding Agents”).

The breath samples detected binding on the nano-optofluidic chip with a secondary antibody to the Spike Protein which was initially selected for the isolated spike protein work. Detection of the live virus was confirmed indicating 9 times increase in the digital spectrum signal on the Microtox® BT when compared to controls of nano-optofluidic chips with binding agent; and 19 times increase in signal with nano-optofluidic chips without binding agents. Additional digital background noise was indicated due to the non-specific binding of the antibody. Further data is required to confirm the same high sensitivity and specificity is achieved on breath test clinical trials which are underway.

Gerard Brandon CEO of DeepVerge plc commented:

“DeepVerge scientists have transformed its AI based water contamination detection system, developed over five years for e.coli, into the breath condensate Microtox® BT unit. Having successfully completed Phase I testing on the Spike Protein and Phase II studies with SARS-CoV-2 virus in the safety of CL3 laboratories, the initial results of Phase III real-world clinical studies in COVID19 patients have reached a major milestone with the demonstration that our Microtox® BT can deliver results in under 60 seconds from breath samples.

“The requirement for the UK Target Product Profile (“TPP”) Rapid Breath Test requires 150 confirmed positive samples and 250 confirmed negative samples. Additional supervised breath test clinical trials from a larger group is expected to provide sufficient data to meet the desired and acceptable criteria in the TPP to roll out the COVID19 and other pathogen breath tests later this year.”

Tracking progress of the stages of the infection

The Company notes the publicationvi by UK Medicines & Healthcare products Regulatory Agency (“MHRA”) of the “Target Product Profile Rapid Breath Tests for the direct and indirect detection of SARS-CoV-2”. Microtox® BT satisfies many of the “Desired” and “Acceptable” criteria within the document.

Subject to the limitations of the Binding Agents’ ability to capture the virus, the Microtox® BT breath test does or does not see the virus, eliminating false positives and enabling each test the potential to predict the following conditions:

• Asymptomatic and non-infectious,

• Asymptomatic and infectious,

• Symptomatic and infectious, and

• Symptomatic and non-infectious

Point-of-Care makes it possible to track and trace the progress of the stages of any infection, including COVID19, subject to the type of pathogen (bacteria, virus, fungi or parasite) or biomarker of a disease being targeted by the Binding Agents.

AI algorithms are designed to assess the risk of steric hindrance, in the case of SARS-CoV-2, by the capture of one S-Protein and one viral particle, blocking the binding of other viral particles in the immediate vicinity.

With ability to detect and identify the binding of individual S-Proteins at Fg/mL, the viral particle can be calculated to generate a bigger shift in the laser signal. Using AI, this relates back in Fg/mL of S-Proteins which indicates a viral load for each test subject.

The joint development program of work on the PBM-HALETM breath condensate device from PulmoBioMed is ongoing using multiplex bio-marker binding agents to analyse breath for 40 other diseases which include cancer, neurodegenerative, respiratory and metabolic conditions.

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Winers Selected in XPRIZE Rapid Covid testing Competition

XPRIZE, the world’s leader in designing and operating incentive competitions to solve humanity’s grand challenges, is pleased to announce today the five winning teams in the $6M XPRIZE Rapid Covid Testing competition, with each winner creating high-quality, affordable COVID-19 testing to help society safely reopen and return to everyday activities. 

Chosen by an independent panel of judges, the grand prize winning solutions are radically affordable compared to what is currently available on the market; and are comparable to commercial offerings at measuring sensitivity, specificity and limit of detection, with a maximum turnaround time of 12 hours from sample to result

The winning teams are: 

Reliable LFC, LLC, Antigen Testing, Carlsbad, United States

ChromaCode, RNA Testing, Carlsbad, United States

Mirimus, RNA Testing, Brooklyn, United States

La Jolla Institute for Immunology, RNA Testing, La Jolla, United States

Alveo Technologies, RNA Testing, Alameda, United States

“We are thrilled to announce the winners of the XPRIZE Rapid COVID Testing, which awarded multiple winners with unique testing solutions to help prevent future supply chain problems,” said Anousheh Ansari, CEO of XPRIZE. “We started this journey to ensure communities across the globe have access to fast, affordable, and easy-to-use COVID-19 tests. We are grateful to have the best entrepreneurial and scientific teams on board to help bring their solutions to scale so we can properly reopen schools, businesses, and other vital institutions around the world.”

Following the December finalist announcements, the 20 teams sent their testing kits and protocols to two separate laboratories, for clinical validation. The independent judges, composed of diverse experts in the healthcare and COVID-19 space, reviewed each team’s lab results, testing concepts, and proposals before deciding on the winners. 

“While vaccines are important, we cannot rely on them alone to prevent the spread of the coronavirus and future outbreaks, especially not until they are provided around the world, en masse and at-scale,” said Jeff Huber, President & Co-Founder of OpenCovidScreen. “These technological breakthroughs in rapid covid testing are providing a safety net to ensure the spread of the disease is contained and to enable a safe return to work and school, and to protect hotspots like nursing homes. These advancements are key to helping underserved, under-resourced communities get access to affordable, accurate tests and to ultimately save more lives now and in the future.”

Additionally, four other teams were selected as winners in the Open Innovation Track, whose approaches demonstrated high potential for impactful screening solutions, but could not be categorized as polymerase chain reaction (PCR), Isothermal Amplification, Next Generation Sequencing, or Antigen Detection and could not be tested through the competition rounds. 

The four winning teams in the Open Innovation Track are: 

Steradian Technologies, Inc., Houston, United States

U-smell-it, Guilford, United States

Ram Global, Zweibrücken, Germany

TeraGroup, Herzliya, Israel

The XPRIZE Rapid Covid Testing judges included:

Dr. Rick Bright, Ph.D, Immunology and Molecular Pathogenesis

Shawna Butler, R.N. M.D.A., Nurse Economist

Dr. Charity Dean, CEO and Co-Founder, The Public Health Company

Dr. Paul Drain, Associate Professor, Departments of Global Health, Medicine and Epidemiology at the University of Washington

Dr. Anita Goel, Physicist and Physician, Chairman and CEO, Nanobiosym

Dr. Michael Mina, Physician-Scientist and Assistant Professor, Epidemiology and Immunology and Infectious Diseases at the Harvard School of Public Health

Dr. Anne Wyllie, Associate Research Scientist, Yale School of Public Health

“The competition was open to all modalities of molecular testing, and the teams submitted an impressive range of ideas. The winners created innovative technologies in rapid PCR, novel antigens, and point-of-care LAMP as well as pioneering some of the first-ever olfaction and breathalyzer tests,” said Chris Mason, Leader of the Science Team and a Professor at Weill Cornell Medicine.

Launched this past July amid the COVID-19 pandemic, this prize comes out of the XPRIZE Pandemic Alliance to bring researchers, innovators, institutions, corporations, and governments together to share ideas and resources in the fight against the current and future pandemics. Since launch, 85 organizations have joined the Alliance, where they have been able to share ideas and research through its digital collaboration platform Exchange, as well as through the XPRIZE Data Collaborative, a unique platform for innovators to collaborate, share and learn from data in a broad spectrum of fields in their search for solutions. 

To amplify impact, a $50 million COVID Apollo Project led by experienced life sciences investors and company builders – including RA Capital, Bain Capital, Perceptive Advisors, Redmile Group, and Samsara Biocapital – will work with OpenCovidScreen, the XPRIZE community, and beyond to accelerate the best ideas, technologies, and innovations to market and scale them.

The Anthem Foundation and Anthem, Inc., serve as the Founding Anchor Partners of XPRIZE Rapid Covid Testing. Seven major national and regional health plans are collaborating as founding partners: Blue Shield of California, Cambia Health Solutions, Inc, Health Care Service Corporation, GuideWell Mutual Holding Corporation, Horizon Healthcare Services, Inc. (NJ), BlueCross BlueShield of South Carolina. Supporting partners include leading healthcare, laboratory and technology companies: Google, Amazon, Ilumina, Ancestry, Testing for America, Thermo Fisher Scientific, Exact Sciences, Centerview Partners, Twist Bioscience, Opentrons, HudsonAlpha Institute for Biotechnology, Weill Cornell Medicine , Biotia, Inc and Medical College of Wisconsin.

Teams will work the remainder of the year to accelerate the adoption of their solutions on a massive scale. XPRIZE will oversee the development of a multimedia playbook documenting the testing protocols,plans implemented and lessons learned at deployment sites where this incredible testing technology will be rolled out. XPRIZE is currently inviting communities like schools, offices, factories, nursing homes, homeless shelters, and other communities to apply to be part of this innovative roll-out. 

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