Friday, May 25, 2018

Scientists Develop New Technique to Detect Chikungunya Virus

Conventionally, Chikungunya is detected through RT-PCR (Real-time polymerase chain reaction) from serum samples or by determination of serum antibodies. These methods are time consuming and the procedure is cumbersome. Thus, there was a need for a rapid and point-of-care diagnostic tool.

Indian scientists have developed a biosensor technique which can be potentially help in detecting Chikungunya virus. According to the scientists, the technique can be used to develop a point of care device for rapid identification of the dreaded disease.

This technique used molybdenum disulphide nanosheets. The researchers synthesized the nanosheets by chemical route and characterized them by using scanning electron microscopy, transmission electron microscopy, UV-visible spectroscopy, Raman spectroscopy and X-ray Diffraction.

Molybdenum disulphide nanosheets were then subjected to physical adsorption onto the screen printed gold electrodes and then employed for the detection of chikungunya virus DNA using electrochemical voltammetric techniques.

This study has been jointly carried out by researchers of Amity University, Noida, Jamia Millia Islamia University, Delhi and Maharishi Dayanand University, Rohtak. The research team has published a report on the study in the recent issue of research journal Scientific Reports.

Conventionally, Chikungunya is detected through RT-PCR (Real-time polymerase chain reaction) from serum samples or by determination of serum antibodies. These methods are time consuming and the procedure is cumbersome. Thus, there was a need for a rapid and point-of-care diagnostic tool.

“Advantages like rapid response time and suitability for mass production associated with detection of DNA hybridization have triggered development of DNA-based electrochemical biosensors. These advantages motivated the present work. A practical advantage of electrochemical detection could have future implications in translating to cheap assays using single-use screen-printed electrodes, which is an ideal tool due to their low cost, disposability and design flexibility as compared to traditional electrode materials,” said the researchers.

However, some other experts felt that the technique was not a new idea as it was used commonly for developing biosensors.

The research team consisted of Dr. Chaitali Singhal, Manika Khanuja, Nahid Chaudhary, C.S. Pundir and Jagriti Narang reports India Science Wire.

Viral-Bacterial Blood Test Company MeMed Gets Comparative Vote of Confidence

A study by Israeli medical researchers compared the company’s automated test to similar ones and found it has the potential to reduce antibiotic overuse by almost 90%.

srael-based automated medical diagnosis startup MeMed Diagnostics Ltd. has received a vote of confidence for the accuracy of its viral-bacterial blood testing device from a team of Israeli medical researchers, the company announced Tuesday. Some of the authors of the article that details the results are MeMed employees.

MeMed, founded in 2009, develops and markets an automated blood testing device capable of diagnosing whether an infection is bacterial or viral—both often presenting with similar symptoms—based on the presence of specific proteins in the blood. Antibiotics are only used for treating bacteria, not viruses, and incorrect prescription can not only cause harm to patients and have a steep price tag, but also lead to the creation of antibiotic-resistant bacteria, also known as “superbugs.”

According to MeMed, its first generation device can provide highly accurate answers within minutes to hours, compared to traditional tests that can take days. The company is currently developing a second generation device that will not necessitate lab access. MeMed raised around $30 million in equity investments so far, and over $25 million in grants from governmental entities, including the U.S. Department of Defense and the European Commission.

MeMed’s device, which is certified in the European Union, has been previously validated in two double-blinded studies. The current team, composed of researchers from Israeli Schneider Children's Medical Center studied the test specifically for patients with respiratory infection (both upper and lower) and fever without source. Based on 314 patients, they compared MeMed’s protein-based test to other methods that use biological markers to test for infection, and to clinical prediction rules.

According to the study, published in April in European Journal of Clinical Microbiology & Infectious Diseases, MeMed’s test was more accurate than any other method tested, including standard laboratory parameters used for patients with infections. MeMed’s analysis also identified 50 out of 57 patients that were already given a prescription for antibiotics as suffering from a viral infection, “suggesting potential to reduce antibiotic overuse by 88%,” according to the study.

"Rapid and actionable diagnostic tools can help physicians make better informed antibiotic treatment decisions,” said in a statement Liat Ashkenazi-Hoffnung of Schneider Children's Medical Center, a co-lead researcher. “The demonstrated potential to reduce unwarranted antibiotic prescription by almost 90% is a key finding."

WHO Publishes First-Ever Essential Tests List

The World Health Organisation has published its first-ever list of essential tests to improve diagnosis and treatment of diseases.

 “An accurate diagnosis is the first step to getting effective treatment,” says Dr Tedros Adhanom Ghebreyesus, WHO director-general.

“No one should suffer or die because of a lack of diagnostic services, or because the right tests were not available.”

The Essential Diagnostic Lists targets common diseases as well as a number of global priority diseases.

It concentrates on in vitro tests—tests of human specimens like blood and urine. EDL also contains 113 products: 58 tests are listed for detection and diagnosis of a wide range of common conditions, providing an essential package that can form the basis for screening and management of patients.
The remaining 55 tests are designed for the detection, diagnosis and monitoring of “priority” diseases such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus and syphilis.

The list comes amidst growing concern that many people are unable to get tested for disease because they cannot access diagnostic service. Many are incorrectly diagnosed and either do not receive the treatment they need or receive the wrong treatment.

Nearly one in two adults with Type 2 diabetes around the global are undiagnosed, risking serious health complications and higher health costs, WHO estimates.

Late diagnosis of infectious diseases such as HIV and tuberculosis increases the risk of spread and makes them more difficult to treat.

Primary health care-suitable

Some of the tests particularly target low-resource settings such as primary health care facilities where laboratory testing is often inadequate or absent.

In such settings, rapid diagnostic kits can detect malaria and glucometers can test for diabetes.
Other tests are more sophisticated and therefore intended for larger medical facilities—from district to regional and onto to national reference labs.

“Our aim is to provide a tool that can be useful to all countries, to test and treat better, but also to use health funds more efficiently by concentrating on the truly essential tests,” says Mariângela Simão, WHO assistant director-general for access to medicines, vaccines and pharmaceuticals.
“Our other goal is to signal to countries and developers that the tests in the list must be of good quality, safe and affordable.”

For each category of test, the Essential Diagnostics List specifies the type of test and intended use, format, and if appropriate for primary health care or for health facilities with laboratories.
The list also provides links to WHO Guidelines or publications and, when available, to prequalified products.

The list, similar to the four-decades-old Essential Medicines Lists, is intended to serve as a reference for countries to update or develop their own list of essential tests.

In order to truly benefit patients, national governments will need to ensure appropriate and quality-assured supplies, training of health care workers and safe use. To that end, WHO will provide support to countries as they adapt the list to the local context.

Smartphones to Become Detectors for Foodborne Illnesses

Foodborne illnesses have received significant publicity recently, whether it’s Salmonella in infant formula or E. coli in flour. Researchers from Purdue University may have found a way to limit the prevalence of these outbreaks by turning smartphones into on-the-spot detectors.

The Food and Drug Administration estimates there are about 48 million cases of foodborne illness annually in the US, and the most recent to gain public attention was the deadly outbreak of E. coli O157:H7 linked to romaine lettuce. As of 8 May 2018, it has infected 172 people from 32 states and so far has caused one death in California.

A number of emerging technologies have investigated ways to deliver quicker and easier detection of these pathogens to ensure greater food safety. Using a downloadable app and a smartphone cradle, the new technology from Purdue researchers allows the phone to be used as an on-site luminometer, an instrument used to measure light.

Rinsing the lettuce or other produce with an enrichment liquid containing a modified phage, a virus for bacteria, would infect harmful foodborne bacteria, causing them to emit a light when a substrate is added. This light is detected by the smartphone’s camera through the app and a green dot appears on the screen. The researchers said the cradle on the phone maximises the photon collection by using diffusive reflection material to help capture a maximum amount of light, which may not be visible to the naked eye.

“This technology could be used on a farm or in a food processing factory to provide on-the-spot detection,” said Euiwon Bae, a Senior Research Scientist in the Purdue School of Mechanical Engineering, who developed the technology along with Bruce Applegate, a Professor in the Purdue Department of Food Science. “This rapid detection is critical for getting safe produce to consumers.”

While current detection methods require sending a physical sample off to the lab — which can take several days to return results — the smartphone technology and phage can test food samples much quicker.

Applegate, the developer of the phage technology, compared it to reprogramming a computer. He stated: “We take the technology and manipulate it to detect various harmful pathogens that are present.”

According to the researchers, the technology is not only useful in detecting strains of E. coli such as the one responsible for the US outbreak. It can also detect other foodborne pathogens that cause Listeria and Salmonella infection outbreaks, and contaminants in water.

The technology is commercialised by Phicrobe, a Purdue University-affiliated start-up founded by Applegate.

NECE’s Project Sea Raven Delivers Cutting-Edge Pathogen Detection Technology to the Fleet

In support of Pacific Partnership 2018, the entomologists and civilian staff of the Navy Entomology Center of Excellence (NECE) delivered cutting-edge technology for disease surveillance to the crew of the USNS Mercy (T-AH 19).

While the ship was docked in Trincomalee, Sri Lanka, NECE connected with the Mercy’s microbiology division to provide a newly-developed pathogen detection kit as well as the training to put it to use.

Pathogens are basically any disease-causing agent, such as viruses, bacteria, or fungi. Identifying pathogens for Sailors and Marines is crucial to ensuring the health and mission readiness of our nation’s warfighters.

The mission was part of NECE’s Project Sea Raven, an effort that is based on providing a highly mobile, complete pathogen surveillance and warfighter protection kit that can deploy to anywhere in the world with our Sailors and Marines. Project Sea Raven’s capabilities are not limited to just insects – it can test anything from blood to soil and water.

The NECE team consisted of Lt. Cmdr. Ian Sutherland, Lt. Matthew Montgomery and Mr. Alden Estep, all of whom have been at the forefront of incorporating the kit into Navy medicine’s capabilities.

Lt. Cmdr. Sutherland, NECE’s technical director, devised Project Sea Raven as a way to increase disease detection capabilities during deployments where new pathogens are frequently encountered and in conditions that make traditional laboratory equipment and methods unworkable.

The kit was presented to Lt. Rebecca Pavlicek, the USNS Mercy’s microbiology division officer, and her division, which is responsible for the study of bacterial, viral, fungal and parasitic pathogens that could affect mission readiness in addition to helping Pacific Partnership nations improve their disease response capabilities.

Funded through a grant from the Defense Health Agency’s (DHA) Global Emerging Infections Surveillance (GEIS) Program, Project Sea Raven is modeled after the MinION system, which is a DNA and RNA sequencing kit.

Built for deployments and field settings, MinION is incredibly light and portable – the entire kit consists of a laptop computer and a small USB device, approximately the size of a cellphone, into which the individual testing cells are inserted. The system works by running purified DNA through an electric current that generates a complete sequence for all genetic information contained in a sample.

Similar to MinION, Project Sea Raven brings rapid results (pathogens can be identified in as little as four hours) and a broader range of pathogens, which can be identified through sequencing.

“The major difference is that Project Sea Raven’s use of sequencing gives us the ability to see so much more than traditional testing,” said Sutherland. “Beyond simple detection, a single sample can be probed numerous times for known and emerging pathogens. You can find multiple viruses, bacteria and fungi from a single sample. You can even look for genetic markers for drug resistance and other important characteristics in those pathogens.”

The joint NECE and Pacific Partnership exercise demonstrated the technology’s ease of use and broad detection abilities.

By the end of the first day of training, the USNS Mercy’s microbiology division was running actual samples from the ship’s medical ward. Because the kit does not require refrigeration or even an internet connection, Project Sea Raven is ideal for shipboard disease surveillance.

For Hospital Corpsman 3rd Class Julian Taylor, medical laboratory technician, the biggest improvement was the amount of time needed to prepare a sample.

“It used to take hours to prepare a sample for testing, but with this, it’s about 15 minutes,” said Taylor.

Project Sea Raven is now an integral part of the ship’s microbiology capacity. As Pacific Partnership 2018 continues, the USNS Mercy will take its new pathogen surveillance capabilities to Vietnam and wherever the ship will provide medical assistance.

For the Sea Raven team, this endeavor represents a culmination of NECE’s commitment to pushing the latest in disease detection technology to the fleet and warfighter.

“This is just the beginning of getting the best disease detection tools to our Fleet’s medical departments,” said Sutherland.

Thursday, May 24, 2018

Rapid, Portable Malaria Diagnostic Tool Developed

Researchers have developed a new portable diagnostic instrument that can screen for all malaria strains within minutes.

The portable optical diagnostics system (PODS) prototype detects a byproduct generated by all species of the malaria parasite.

"With PODS, we can do rapid, broad population screening for malaria in low-resource environments," said Andrea Armani from the University of Southern California (USC) in the US.

"When combined with currently available therapeutics, this could represent a tipping point in the global fight against malaria," said Armani.

The PODS instrument was designed to solve the challenges limiting current systems, researchers said.

To minimise size, weight, and power requirements without sacrificing performance, every aspect was considered, they said.

The current prototype weighs fewer than 4.5kg, is 12 by 10 inches (the size of a large shoebox) and can be powered by a battery for eight hours.

In addition, PODS was designed to require minimal sample processing and handling, as well as eliminate the need for secondary chemicals with strict storage requirements.

This makes the device particularly suited to low-resource environments, researchers said.

The prototype can analyse an unprocessed, whole blood sample in 10-15 minutes.

With only 500 microlitres of blood (five to seven drops), it can achieve sensitivity levels needed for an early-stage diagnosis.

Malaria-infected mosquitoes infect human hosts with the parasite. Its primary nutrient source is hemoglobin, a component of red blood cells.

As the parasite digests hemoglobin, it creates what is known as heme as a byproduct.

"While heme is highly toxic to both the parasite and its host, the parasite has figured out a 'loophole' around this by aggregating heme into an insoluble nanocrystal known as hemozoin," said Samantha McBirney, a PhD graduate at USC.

PODS has three primary components: a laser, a detector (to detect light), and a magnet.

When a sample of blood is placed between the laser and the detector, the amount of light that makes it to the detector decreases as the blood blocks it.

If hemozoin is present, even less light shines through, researchers said.

At high concentrations even in blood, it is readily apparent if hemozoin is present because the nanocrystal is very good at blocking light, they said.

Chembio Diagnostics to Sell Rapid Tests for Zika and Other Viruses in Brazil

Chembio Diagnostics Inc. plans to sell rapid tests for Zika and other viruses in Brazil, executives said Thursday. The company developed the tests with a government agency there.

The Medford-based manufacturer of diagnostic tests for HIV, syphilis and fever illnesses said it has signed a long-term agreement with Bio-Manguinhos in Brazil to commercialize the tests for Zika, dengue and chikungunya in the country.

Bio-Manguinhos is a division of the Oswaldo Cruz Foundation, an agency that develops and produces tests, vaccines and medicine for Brazil’s national health system. It has worked with Chembio for 14 years.

Since 2016, Chembio and Bio-Manguinhos have been working on stand-alone tests for Zika, dengue and chikungunya and tests where more than one illness can be detected. The products have undergone clinical trials and some have won governmental approvals in Brazil, the United States and Europe.

Separately in November, Chembio announced that it had signed a contract valued at up to $4.9 million with UNICEF to provide the Zika test and a companion results reader for use primarily in Africa.

Since 2015 there have been Zika outbreaks in more than 80 countries, including in the United States. The virus takes its name from the Ugandan forest where it was first identified in 1947.

Zika causes the birth defect microcephaly, in which infants have smaller-than-normal heads.

“Despite improved prevention measures to combat the viruses, the risk of incipient epidemic remains in many parts of Brazil,” Chembio CEO John J. Sperzel said Thursday. The company’s tests “can become important tools to discriminate among the viruses and identify co-infected patients, as we battle these debilitating and often life-threatening viruses,” he said.

Wednesday, May 09, 2018

New Early-Warning Device To Detect Infection In Dialysis Patients Completes Successful Clinical Pilot In Manchester

An innovative solution designed to identify infection in dialysis patients has completed a successful pilot clinical investigation following a funding award from Health Innovation Manchester.

Manchester-based medical device company Microbiosensor, secured £50,000 from the Energise Innovation Fund in 2016 to pilot their PD Safe device in Manchester.

The PD Safe is aimed at those on peritoneal dialysis therapy (PD) and acts as an early warning system for peritonitis, an infection that can prove fatal if left untreated.

PD is the lowest cost and least lifestyle compromising form of renal dialysis available in the UK, however less than 10 per cent of patients on renal replacement therapy are on PD, with an average therapy duration of only five years.

Recurrent infections are a major cause of technique failure of PD and current best practice relies on patient’s self-reporting possible symptoms of infection — abdominal pain, fever and visually checking a clear plastic waste bag for signs of cloudiness in their PD waste.

However, as the symptoms are not specific and not detectable until an infection has become well-established, patients can find making a judgement stressful and difficult – leading to a delay in time to diagnosis and treatment.

The PD Safe aims to overcome this issue by plugging into existing PD waste fluid tubing and flagging an emerging infection at a pre-symptomatic stage via a simple colour change in a readout window.

The device uses a small dialysis waste sample from the patient to fill a series of reaction chambers containing chemicals which can detect bacteria and provide a rapid, clear colour change to alert the user to the infection.

Following the funding award, Microbiosensor have completed a successful pilot clinical investigation of the PD Safe device at the Manchester Royal Infirmary renal centre, working with Consultant Nephrologist Dr Anand Vardhan at the PD clinic.

The device successfully acted as an early warning system for infection, detecting bacteria within samples from patients, including one who was admitted to A&E within a few days as they went on to develop peritonitis.

Ben Bridgewater, CEO of Health Innovation Manchester, said: “The PD-Safe device is an excellent example of the solutions Health Innovation Manchester aims to support in their journey to market.

“The successful pilot clinical investigation in Greater Manchester marks a great leap forward in the project which has the potential to meet the needs of local people and patients.

“It is vital that products like the PD-Safe are given support in order to transform health and social care and Health Innovation Manchester is uniquely placed to champion these innovations and connect researches, academics, business and the NHS in Greater Manchester.”

Gordon Barker, CEO of Microbiosensor, said: “The Energise funding from Health Innovation Manchester helped Microbiosensor improve its understanding of clinical trial management at a major NHS Trust and strengthen the design of a subsequent larger study at Manchester Royal Infirmary.

“It has made a significant contribution to Microbiosensor efforts to bring its novel medical device technology to market.”

Microbiosensor has also secured a £1.4million Series-A co-investment from the Northern Powerhouse Investment Fund (managed by Maven Capital Partners) and the Greater Manchester and Cheshire Fund (managed by Catapult Ventures) to support the company through it final product development stages.

Karius Announces Launch of Quantitative, Broad-Based Infectious Disease Diagnostic Test Using Microbial Cell-Free DNA

Karius, the leading U.S. infectious disease genomics company, announced today that the new version of its proprietary Karius Test can now quantify the abundance of pathogens detected. The test uses next-generation sequencing of microbial cell-free DNA (cfDNA) to identify over 1,000 pathogens from a single blood sample. Results are typically delivered the next day*. Karius is announcing its latest advances at the first annual HLTH “The Future of Healthcare” conference and is making the test immediately orderable to physicians nationwide**.

The Karius Test uses next-generation sequencing (NGS) to enable broad and rapid detection of bacteria, DNA viruses, fungi and protozoa in one broad-based test for infectious diseases. With a standard blood draw, the test identifies cell-free DNA (cfDNA) fragments left by microbes in a patient’s bloodstream, even when living organisms are no longer detectable in the blood or when patients have been pre-treated with antibiotics. Karius reports the presence and abundance of microbial cfDNA to physicians when statistically significant levels are detected above background.

“The new quantitative capabilities we added to our test give clinicians even greater insight – now not only delivering answers on which pathogens are present, but also the extent of the infection, enabling doctors to make more informed treatment decisions,” said Karius CEO Mickey Kertesz, Ph.D. “We are committed to delivering the highest quality service for clinicians to more rapidly diagnose infectious diseases, helping save lives in the most challenging diagnostic dilemmas including immunocompromised patients, complicated pneumonia, culture-negative bloodstream infections and invasive fungal infections.”

The Karius Test has been commercially available for over a year and has helped clinicians accurately detect pathogens in diagnostically challenging situations, including sepsis, endocarditis, fever of unknown origin, and in patients who have received antibiotic pre-treatment. It has also been useful for hematologist-oncologists who actively monitor immunocompromised patients susceptible to a broad range of pathogens, including stem-cell transplant recipients.

Dr. Kertesz will participate in the “Next Gen Genomics” panel discussion at HLTH on May 8, moderated by Jon Shieber, senior editor at TechCrunch. The panelists will discuss the immense potential of genomics and areas within the field that need further development.

HLTH is a leading event for innovation in healthcare that is creating a dialogue focused on disruptive innovation across the healthcare ecosystem. The HLTH agenda for 2018 will feature over 300 speakers from today’s most successful and innovative companies and thought leaders in the industry.

*From receipt for about 80% of samples received by 8:30 a.m. Monday to Friday.
**Karius is not yet a New York State-approved clinical laboratory, thus it cannot accept orders for patients in that state without an exemption.

Monday, May 07, 2018

Cepheid Receives FDA Clearance and CLIA Waiver for Xpert Xpress Strep A

Cepheid announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and waiver under the Clinical Laboratory Improvement Amendments (CLIA) for the Xpert® Xpress Strep A test. The test can be performed in near-patient settings by untrained users, to provide rapid and accurate molecular detection of Streptococcus pyogenes (i.e., Group A Strep) in as little as18 minutes.1

"The rapid results provided by Xpert Xpress Strep A test can facilitate antimicrobial stewardship in the outpatient setting consistent with renewed healthcare provider focus on the reduction of unnecessary antibiotic use in ambulatory care settings. It also leverages the versatility of our platform to improve patient care," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.

Xpert Xpress Strep A utilizes automated real-time polymerase chain reaction -PCR- to detect Streptococcus pyogenes DNA. The on board reagents deliver high-performance specifications with no requirements for culture confirmation of negative results unless clinical symptoms persist or there is an outbreak of acute rheumatic fever.

Mologic Signs Agreements with Two Medical Companies for Distribution of Point-of-Care Test

Mologic (developer of personalised diagnostics) has signed agreements with two medical companies, Medisur and Peripal, for the distribution of a rapid point-of-care (POC) test for the detection of infection in patients on peritoneal dialysis (PD) — PERiPLEX.

Both medical companies involved in this agreement specialise in the development and distribution of products that enable patient self-management. Under the terms of the agreement, they will supply PERiPLEX as part of a product portfolio in key European markets including France, Germany, Italy, The Netherlands, Austria and Switzerland.

PD is becoming widely accepted as a preferred method for managing end-stage renal disease as it offers greater patient mobility and independence compared to other dialysis options, as well as being gentler to residual kidney function in early-stage disease. Recurring infection, or peritonitis, is a major issue for PD patients especially as there is no effective diagnostic test that can provide early indication of infection. Using current methods, diagnosis of infection can take more than 24 hours, which risks damage to the peritoneal membrane, or the formation of scar tissue, preventing long-term use of PD.

The rapid POC test detects two critical biomarkers of infection in PD waste fluid using a lateral flow immunoassay system and provides a visual result within 10 minutes. A positive result indicates to patients that there is an infection and therefore can be used to initiate contact with their healthcare provider for antibiotic therapy.

Earlier identification of infection can enable pre-emptive antibiotic therapy, resulting in improved management of infection and prevention of infection-related damage to the peritoneal membrane.

“Establishing a global distribution network is integral to Mologic’s product commercialisation strategy,” commented Mark Davis, co-founder and CEO at Mologic. “With the appointment of distributors across Europe we will ensure PERiPLEX is available to more patients, giving them greater choice and the confidence to monitor their dialysis at home. Medisur and Peripal share our mission to improve the lives of patients by bringing diagnostics and treatment closer to home, and with highly complementary product portfolios, we look forward to working together.”

The PERiPLEX technology was developed following a collaborative project with Cardiff University Medical School, funded by the National Institute of Health Research (NIHR).

New Technique Allows Quick Detection of Virus in Bodily Fluids

Broad Institute of MIT and Harvard researchers have created a new tool that better prepares the CRISPR-based diagnostic tool, SHERLOCK, for rapid response to viral outbreaks.

The updates allow clinicians to quickly and cheaply diagnose patient samples and track epidemic spread directly in bodily fluids, eliminating the need for excessive lab equipment and allow more rapid efforts to be conducted in the field. SHERLOCK has also been updated to better distinguish between related viral species, allowing it to identify mutations.

“Rapid and sensitive tools are critical for diagnosing, surveilling, and characterizing an infection,” Pardis Sabeti, an institute member at Broad, a professor at Harvard University, and Howard Hughes Medical Investigator, as well as senior study author, said. “We’ve taken the SHERLOCK technology and optimized it in the context of these very applied biological scenarios.”

Sabeti’s team hopes to build on this further and seeks to test SHERLOCK with Nigerian collaborators, as a means of addressing their recent Lassa fever outbreak. The recent effort was led by Harvard graduate student Catherine Freije and postdoctoral scientist Cameron Myhrvold, who developed a simpler method for an enzyme involved in the platform to detect its target directly in bodily fluid samples.

“In places like South America, many similar viruses co-circulate, and having a diagnostic that can quickly tell the difference is critical,” Freije said. “With this new assay, a patient can give a single blood or urine sample, it can be analyzed in just a few reactions to determine which virus it contains, and then that patient can get started on the right treatment.”

Already, the team has shown SHERLOCK’s sensitivity to mutations that occur in something as small as a single nucleotide and designed assays that could identify Zika virus mutations associated with microcephaly. Broad hopes to make the SHERLOCK diagnostic platform easily accessible in the developing world.

PositiveID’s ExcitePCR FireflyDX Prototype Successfully Detects E. Coli in Less Than 30 Minutes

PositiveID Corporation announced today that the FireflyDX breadboard prototype pathogen detection system can accurately detect the E. coli bacterium in less than 30 minutes. Further, the Company commented on the importance of its rapid, portable pathogen detection products, currently under development, to prevent increasingly frequent foodborne disease outbreaks.

In scenarios where containment is key to preventing widespread accidental or bioterror-driven health disasters, immediate action can mean the difference between single digit and hundreds of cases, as seen in recent instances.

FireflyDX is designed to detect E. coli and other pathogens at the point of need, eliminating the delays that result from having to transport samples for off-site lab testing to receive potentially life-saving results.

The recent multi-state outbreak is the worst outbreak of E. coli since 2006 when illnesses traced to spinach killed three people and sickened more than 270, creating millions of dollars in legal liability.

The ability to rapidly and accurately diagnose pathogenic E. coli at the point of need gives health care providers information required for correct treatment protocols and for public information campaigns.

Further, millions of dollars in legal awards are paid annually due to foodborne illness. Through implementation of on-site detection at local food processing facilities, legal liability for outbreaks can be significantly minimized. PositiveID believes that completion and commercialization of FireflyDX could be a solution that enables such prevention.

FireflyDX Evidence

The graph below shows FireflyDX successful detection of E. coli using its own assay:

“FireflyDX is being developed to prevent and more effectively respond to disease outbreaks and minimize the spread of infection,” commented Lyle L. Probst, ExcitePCR President and CEO. “Use of FireflyDX at the farm, food processing facility, or the restaurant level, can equip health care professionals with an unprecedented level of information to stop such food safety issues before they become a public health concern.”

E. coli is a bacterium commonly found in the lower intestine of warm-blooded animals.  Most E. coli strains are harmless, but some kinds, like E. coli O157:H7, can cause serious disease in humans including bloody diarrhea and hemolytic uremic syndrome, a type of kidney failure. Food contamination can occur when food products come into contact with fecal material in soil, water, or contaminated surfaces.  This contamination can cause food poisoning in humans and result in serious illness and costly product recalls.

PositiveID expects that FireflyDX vertical markets will include human clinical, such as infectious disease, and hospital acquired infections, global food and agricultural, and biothreat defense.