PRESS RELEASE: Accelerate Diagnostics Seeks FDA 510(k) Clearance for Expanded Abx Susceptibility Tests

Accelerate Diagnostics has filed a 510(k) premarket submission for a gram-negative menu expansion and breakpoint updates for its Accelerate PhenoTest BC kit used for antimicrobial susceptibility testing.

A previous version of the test and the Accelerate Pheno system received US Food and Drug Administration clearance in 2017 for rapid pathogen identification and phenotypic antibiotic susceptibility testing. In 2021, the firm began selling a new configuration of the kit in the US and secured CE marking for that configuration. The Tucson, Arizona-based firm said its recent 510(k) submission includes escalation and de-escalation agents for gram-negative organisms, additional antibiotics for treatment of Acinetobacter baumannii infection, and breakpoint updates for existing susceptibility measures. It also includes oral antibiotic options for de-escalation, which can aid patient discharge planning.

The Accelerate Pheno system and BC kit provide fully automated sample preparation and results in about seven hours direct from positive blood cultures.

Accelerate CEO Jack Phillips said in a statement that the updated PhenoTest panel "adds meaningful new antibiotic choices for clinicians to minimize time to optimal therapy for patients with bloodstream infections."

"These additions and improvements will increase the value of the Pheno system in hospitals across the country, enhancing the clinical value labs have been experiencing for the past several years," he said.

The firm said in May it plans to launch and commercialize a new system for MALDI mass spectrometry and update its Pheno platform, with clinical trials of the Pheno II instrument planned for 2023. It also entered into a commercial agreement this August with Becton Dickinson, which will sell the Accelerate Pheno system and Accelerate Arc module for antimicrobial susceptibility testing.

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PRESS RELEASE: Thermo Fisher Scientific Launches TrueMark Infectious Disease Research Panels

Thermo Fisher Scientific, the world leader in serving science, today announced the launch of the TrueMark Infectious Disease Research Panels designed to enable rapid and accurate detection and categorization for investigating microorganisms that cause respiratory, vaginal, urinary, gastrointestinal, and sexually transmitted diseases.

To effectively study outbreaks and determine disease etiology where pathogens are similar, analytically sensitive panels are needed to support laboratory research. TrueMark Infectious Disease Research Panels are analytically sensitive, real-time polymerase chain reaction (PCR) syndromic panels for the analysis of a wide range of infectious disease pathogens.

Leveraging real-time PCR technology, the predefined and customizable panel options allow researchers to choose from more than 90 different bacterial and viral strain assays to generate results within four hours from taking the samples.

“With the TrueMark Infectious Disease Research Panels, laboratories can choose either the readymade panels or create their own custom panels to suit their needs,” said Dr. Manoj Gandhi, senior medical director of Genetic Testing Solutions at Thermo Fisher Scientific. “By providing the flexibility to choose panels for researching polymicrobial infections, laboratories can now expand their testing menus using existing instrumentation and offer the benefits of PCR testing for researching a broad range of markers that can cause infectious disease.”

The assays use pre-spotted and dried down TaqMan plates, which are designed to enable easy set-up and increased accuracy. Testing can be done from nasopharyngeal swabs or nasopharyngeal aspirate, vaginal, genital and lesion swabs or urine samples. These samples can also be prepared using workflows that currently exist in most labs that use the Applied Biosystems MagMAX Viral/Pathogen kits automated on a KingFisher Purification System instrument and mixed with the Applied Biosystems multiplex master mix onto a 96-well or 384-well plate.

The panels are optimized for use on QuantStudio qPCR systems with verified sample-to-answer workflow and provide easy to read results with the Applied Biosystems QuantStudio Design and Analysis Software v2.6.

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Point-of-Care Test Identifies Bacterial and Viral Causes of Acute Respiratory Infections

A point-of-care test shows good sensitivity for identifying both bacterial and viral pathogens in patients with acute respiratory infections.

A point-of-care test has been found to correctly distinguish between bacterial and viral infections based on the host’s immune response, among patients with acute respiratory infections according to the results of a diagnostic study by team of US researchers.

Respiratory symptoms are the motive for a third of emergency room visits by both adult and paediatric patients. Acute respiratory infections due to either acute bronchitis, sinusitis, pneumonia and the common cold often present with overlapping symptoms leading to over-prescribing of antibiotics. Although multiplex PCR systems are available for the identification of bacterial and viral pathogens, an alternative strategy is to use a point-of-care test based on the host’s immune response to myxovirus resistance protein A (MxA) and C-reactive protein (CRP) in a finger-stick whole blood sample. To test the value of this approach in helping clinicians to decide on whether or not to prescribed antibiotics, in the present study, the US team examined the ability of the FebriDx® which is a rapid, point-of-care diagnostic test that is designed to aid in the differentiation of bacterial and viral acute respiratory infections. The test can provide a result within 10 minutes by identifying myxovirus resistance protein A, which is induced by type 1 interferon due to viral infections and CRP, a non-specific acute-phase protein produced in response to inflammation and infection. While CRP is not specific for bacterial infections, if only MxA levels are elevated (i.e., no change in CRP) this is indicative of a viral infection. Similarly, elevated CRP in the absence of MxA, indicates a bacterial infection.

The US team recruited patients from emergency departments and outpatient settings who presented with new-onset respiratory symptoms including rhinorrhoea, nasal congestion, sore, throat, hoarseness, cough or shortness of breath and a recent fever and an asymptomatic control group. The point-of-care test was administered to both groups of patients although the treating physicians were blind to the test results. The primary outcome was set as a bacterial or viral-associated systemic host response. In addition, patient samples were collected and analysed by multiplex PCR for either viral or bacterial identification and which served as independent assessment of the point-of-care test result.

Point-of-care test and bacterial or viral identification

A total of 520 symptomatic patients with a mean age of 35.3 (44.2% male) were included and 170 in the asymptomatic group.

Final diagnostic information was available for 496 individuals and of whom, 14.7% had a confirmed bacterial and 59.7% a viral infection with the remainder classed as negative. The point-of-care test correctly identified 93.1% of bacterial infections giving a sensitivity of 93.2% (95% CI 84.9 – 97%), a specificity of 88.4% (95% CI 85 – 91.1%) and a positive predictive value of 58.1%.

For viral infections, the point-of-care test had a sensitivity of 70.3% (95% CI 64.8 – 75.2%), a specificity of 88% (95% CI 82.8 – 91.8%) and a positive predictive value of 89.7%. Interestingly, none of the participants had a co-infection which was defined as both a bacterial and viral pathogen plus a host response based on the independent assessment.

The authors concluded that the rapid diagnostic point-of-care test could help inform clinicians when assessing for either bacterial or viral causes for acute respiratory infections.

Citation

Shapiro NI et al. Diagnostic Accuracy of a Bacterial and Viral Biomarker Point-of-Care Test in the Outpatient Setting JAMA Netw Open 2022

https://pubmed.ncbi.nlm.nih.gov/36255727/

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PRESS RELEASE: Nissui Pharma Solutions Launches its Mycoplasma Detection Kit in EMEA

Nissui Pharma Solutions (NPS), European subsidiary of Nissui Pharmaceutical Japan, commercialises contamination detection kit for the production of cell culture derived biopharmaceutical products. 

MycoFinder, our rapid mycoplasma detection kit, has been validated in accordance with the EP 2.6.7, USP 63 and JP 17 and is now commercially available throughout EMEA. MycoFinder uses real-time fluorescent PCR to ensure sensitive detection (below 10 CFU/mL) of mycoplasma. The kit is simple and quick to implement for product screening and batch release in laboratories where time is of the essence.

MycoFinder: sensitivity, simplicity and speed 

MycoFinder is in a PCR tube strip format with all the components of the Master Mix freeze-dried in each PCR tube. This allows preparation of PCR reactions in minutes, the Master Mix is resuspended simply by adding 25µL of DNA sample directly into the tubes. 

The kit is compatible with most commercially available thermocyclers due to two formats of PCR strips (white and clear). The ease of use of the MycoFinder kit, combined with the optimised Master Mix, results in PCR data in less than one hour.

For more information, please visit www.nissui-ps.com.

Christopher Tarabay

Commercial Director NPS

christopher.tarabay@nissui-ps.com

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DNA Nets Capture COVID-19 Virus in Low-Cost Rapid-Testing Platform

Tiny nets woven from DNA strands can ensnare the spike protein of the virus that causes COVID-19, lighting up the virus for a fast-yet-sensitive diagnostic test – and also impeding the virus from infecting cells, opening a new possible route to antiviral treatment, according to a new study.

Researchers at the University of Illinois Urbana-Champaign and collaborators demonstrated the DNA nets’ ability to detect and impede COVID-19 in human cell cultures in a paper published in the Journal of the American Chemical Society. 

“This platform combines the sensitivity of clinical PCR tests and the speed and low cost of antigen tests,” said study leader Xing Wang, a professor of bioengineering and of chemistry at Illinois. “We need tests like this for a couple of reasons. One is to prepare for the next pandemic. The other reason is to track ongoing viral epidemics – not only coronaviruses, but also other deadly and economically impactful viruses like HIV or influenza.”   

DNA is best known for its genetic properties, but it also can be folded into custom nanoscale structures that can perform functions or specifically bind to other structures much like proteins do. The DNA nets the Illinois group developed were designed to bind to the coronavirus spike protein – the structure that sticks out from the surface of the virus and binds to receptors on human cells to infect them. Once bound, the nets give off a fluorescent signal that can be read by an inexpensive handheld device in about 10 minutes.

The researchers demonstrated that their DNA nets effectively targeted the spike protein and were able to detect the virus at very low levels, equivalent to the sensitivity of gold-standard PCR tests that detect the virus’s genetic material but can take a day or more to return results from a clinical lab.

The technique holds several advantages, Wang said. It does not need any special preparation or equipment, and can be performed at room temperature, so all a user would do is mix the sample with the solution and read it. The researchers estimated in their study that the method would cost $1.26 per test.  

“Another advantage of this measure is that we can detect the entire virus, which is still infectious, and distinguish it from fragments that may not be infectious anymore,” Wang said. This not only gives patients and physicians better understanding of whether they are infectious, but it could greatly improve community-level modeling and tracking of active outbreaks, such as through wastewater.

In addition, the DNA nets inhibited the virus’s spread in live cell cultures, with the antiviral activity increasing with the size of the DNA net scaffold. This points to DNA structures’ potential as therapeutic agents, Wang said.

“I had this idea at the very beginning of the pandemic to build a platform for testing, but also for inhibition at the same time,” Wang said. “Lots of other groups working on inhibitors are trying to wrap up the entire virus, or the parts of the virus that provide access to antibodies. This is not good, because you want the body to form antibodies. With the hollow DNA net structures, antibodies can still access the virus.”

The DNA net platform can be adapted to other viruses, Wang said, and even multiplexed so that a single test could detect multiple viruses.

“We're trying to develop a unified technology that can be used as a plug-and-play platform. We want to take advantage of DNA sensors’ high binding affinity, low limit of detection, low cost and rapid preparation,” Wang said.

The National Institutes of Health supported this work through the Rapid Acceleration of Diagnostics program. The researchers will continue to work through the RADx program to explore and accelerate clinical applications for the DNA net platform.

Wang also is affiliated with the Holonyak Micro and Nanotechnology Lab and the Carl R. Woese Institute for Genomic Biology at Illinois.

The paper “Net-shaped DNA nanostructures designed for rapid/sensitive detection and potential inhibition of the SARS-CoV-2 virus” is available at https://pubs.acs.org/doi/10.1021/jacs.2c04835.

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OpGen, FIND Sign R&D Collaboration for Rapid Detection of AMR via Blood Culture

OpGen announced Tuesday it has signed a research and development collaboration agreement with FIND, a global alliance focused on bringing diagnostics throughout the developing world, for a feasibility study on the use of Unyvero A30 RQ platform for use in rapid pathogen ID and antimicrobial resistance (AMR) testing from blood culture samples in low- and middle-income countries (LMICs).

During the feasibility study, scientists at OpGen’s German subsidiary Curetis will work to develop a molecular testing panel with a comprehensive set of pathogen ID and AMR detection assays while also creating a simple, easy-to-perform workflow for testing using the blood culture systems available in target regions without the need for sample preparation. The collaboration’s goal is to find methods to adapt the A30 RQ platform—which is capable of test for up to 33 diagnostic targets from a single specimen—for use in environments often found in LMICs, such as those with continuous operation with unstable power grids.

“AMR is one of the most pressing health emergencies of our time, with the potential to undo decades of medical progress,” said Cecilia Ferreyra, director of AMR at FIND. “Simplifying blood culture systems so that the pathogen responsible for an illness and its resistance profile can both be identified quickly is crucial for halting and preventing this silent pandemic, especially in LMICs that bear the greatest burden of AMR.”

Based on the results of the feasibility study, co-funded by FIND with €700,000, which is anticipated to be completed by the end of the first quarter of 2023, OpGen and FIND will discuss the option of future collaboration and a commercialization agreement. Such a collaboration would be focused on bringing the Unyvero A30 RQ platform and the first products developed in the feasibility collaboration through the necessary clinical studies for marketing approval. Further, the two partners aim to develop the products that can be sold at a price point that will encourage the use of the tests to help address the unmet testing need for AMRs in LMICs.

OpGen noted that the platform, which uses a one-time use disposable cartridge and can deliver results in 30 to 90 minutes depending on the complexity of the test being run, is a good candidate for use in LMICs for rapid AMR detection due to the low cost of good associated with producing the assays.

“We are excited to partner with FIND, in demonstrating that our Unyvero A30 RQ platform is ideally suited to being used in LMICs for rapid detection of AMR which is a truly global issue that must be addressed in a multilateral and indeed global fashion,” said Oliver Schacht, president & CEO of OpGen in a press release. “The R&D contract and associated funding will support the required R&D efforts on our side and expedite such development.”

FIND (Foundation for Innovative New Diagnostics), based in Geneva, Switzerland, was created in 2003 at the World Health Assembly to address the pressing need for affordable diagnostic tests in LMICs. It was launched by the Bill and Melinda Gates Foundation and World Health Organization’s Special Programme for Research and Training in Tropical Diseases (TDR). Its initial focus was to speed up the development and evaluation of tuberculosis tests. Since then, its work has expanded to include improving diagnosis in other diseases including hepatitis C, HIV, malaria, and neglected tropical diseases.

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PRESS RELEASE: BD MAX™ Molecular Multi-Drug Resistant Tuberculosis Test To Be Included In WHO Updated Consolidated Guidelines On Tuberculosis

BD, a leading global medical technology company, today announced that its BD MAX™ Molecular Multi-Drug Resistant Tuberculosis (MDR-TB) Assay was included in the moderate complexity automated NAAT class of molecular diagnostic technologies that were recognized for high diagnostic accuracy for tuberculosis testing by the World Health Organization (WHO) in advance of an update to its guidelines for TB diagnostic tests.

Laboratorians and clinicians can use the BD MAX™ MDR-TB Assay to simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain mutations associated with resistance to two important first-line drugs, isoniazid (INH) and rifampicin (RIF), enhancing the information available to direct the optimal treatment for their patients.

"BD is keenly focused on the fight against antimicrobial resistance and we believe the BD MAX™ MDR-TB Assay will make a real impact on the detection of MDR-TB and better inform which treatment regimen to use for TB patients," said Dave Hickey, president of Life Sciences for BD. "This recognition by WHO is a significant milestone for this product and furthers BD's commitment in the fight to end TB. We look forward to WHO releasing its updated guidelines later this year."

The BD MAX™ MDR-TB Assay is an in vitro diagnostic device with CE mark available in Europe and other countries around the world. The PCR-based molecular diagnostic test is an integrated diagnostic test intended to help in the detection and diagnosis of TB, and INH and RIF resistance in a single assay.

Every year, about 10 million people develop TB and 1.4 million die from the disease. Until the global COVID-19 pandemic, TB was the leading cause of death from a single infectious agent. With proper detection and treatment, TB is curable. Multidrug-resistant TB (MDR-TB), defined as resistance to both isoniazid and rifampicin, remains a critical hurdle in the fight to eradicate tuberculosis as patients with this type of TB will not benefit from those key medicines and could spread the resistant forms of the disease to others.1 Additionally standard testing that only detects RIF resistance can miss cases of TB infection resistant to INH further delaying appropriate treatment and cure for those in need.

BD has a long history in TB diagnostics, having launched the first automated liquid culture system, the BD BACTEC™ MGIT™ Automated Mycobacterial Detection System for comprehensive testing for TB, drug susceptibility and monitoring patients' response to treatment. The BD MAX™ MDR-TB Assay complements this technology enabling clinicians to rapidly test for TB and multidrug resistance as a first-line test and then use the BD BACTEC™ MGIT™ System for broader drug susceptibility testing and patient monitoring.

BD offers a free on-demand webinar featuring Dr. Daniela Maria Cirillo, president of the European Society of Mycobacteriology and head of the Emerging Bacterial Pathogen Research unit at San Raffaele Scientific Institute in Milan. The webinar explores the importance of laboratory diagnostics to stop TB, as well as how the STOP TB Partnership and the ongoing work of the European Society of Mycobacteriology are working to help fight TB. View the on-demand webinar at labroots.com (https://www.labroots.com/webinar/importance-laboratory-diagnostics-fight-tuberculosis).

About BD MAX™ SYSTEM

The BD MAX™ System is a molecular diagnostic platform already in use at thousands of laboratories worldwide. The system is fully automated, reducing the opportunity for human error and increasing the speed to result, and can process 24 samples simultaneously, and up to several hundred samples per 24-hour period. Each unit is capable of performing assays for respiratory infections, enterics, hospital acquired infections, and sexually transmitted infections.

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Scientists Create a DNA Test That Identifies Lyme Disease in Horses

A test under development by a Rutgers professor could have applications for humans and dogs, too

A Rutgers scientist aiming to help heal a sick horse created an ultra-sensitive DNA test that could have applications for difficult-to-detect illnesses in humans such as Lyme disease.

As described in a study published in the Journal of Veterinary Diagnostic Investigation, a special DNA test devised by Steven Schutzer, a professor of medicine at Rutgers New Jersey Medical School, helped a Cornell University School of Veterinary Medicine team identify Neurologic Lyme disease in a sick 11-year-old Swedish Warmblood mare.

Although Lyme disease was suspected, a standard PCR test didn’t detect the disease agent, the corkscrew-shaped bacterium Borrelia burgdorferi.

As with the treatment of most diseases, early detection is essential with Lyme.

“Early diagnosis leads to immediate treatment,” Schutzer said. “And, naturally, that gives the best chance for a cure.”

The Schutzer team’s “genomic hybrid capture assay,” a highly sensitive test the team has been developing, identified the pathogen in a sample of the horse’s spinal fluid, allowing it to be diagnosed and successfully treated. The test works by first selectively isolating DNA from the microorganism causing the disease.

“The method is like having a special, specific ‘fishhook’ that only grabs Borrelia DNA and not the DNA of other microbes, nor the DNA of the host (animal or human),” Schutzer said. “Detecting DNA of the disease is a direct test, meaning we know you have active disease if it’s circulating in the blood or spinal fluid.”

Lyme disease is the most common vector-borne illness in the U.S., according to the Centers for Disease Control and Prevention (CDC). In humans, a characteristic skin rash may or may not occur, along with fever, headache and fatigue. Unchecked, the infection can move to the nervous system, the joints and the heart.

Similar to humans, horses are incidental, dead-end hosts for B. burgdorferi, meaning the hosts carry the infection but do not infect others. Not all infected horses develop clinical signs of Lyme disease. If symptoms occur, they can include chronic weight loss, lameness and low-grade fever. Antibody tests usually are administered when a Lyme disease infection is suspected.

In the case described in the study, an antibody test and a PCR test of the mare didn’t indicate an infection. Only Schutzer’s advanced test detected the disease.

Lyme disease in horses can cause long-term complications that include damage to the nervous system, joints, skin and even vision.

“The diagnosis of Lyme neuroborreliosis (Neurologic Lyme disease) in horses is rarely confirmed antemortem and has frustrated veterinarians for years,” said Thomas Divers, the veterinarian who led the equine team on the paper and who is a professor of medicine and co-chief of the Section of Large Animal Medicine at Cornell University’s College of Veterinary Medicine in New York. “This is a very promising technique. Focused treatment against B. burgdorferi administered in this case resulted in the horse’s complete athletic recovery.”

While many illnesses, such as COVID-19 and strep throat, attack humans with many numbers of pathogens, in other diseases, such as Lyme disease, the bacteria slowly reproduce within a host, producing far fewer numbers and making detection more difficult.

Schutzer, an expert in Lyme and other tick-borne diseases, has been working to devise ways to better detect diseases that possess what he terms “low copy numbers” of a pathogen.

According to the CDC, about 476,000 cases of Lyme disease are reported in humans each year. The black-legged tick, also known as the deer tick, is responsible for most cases of Lyme disease in the U.S. and seems to be increasing in abundance and geographic spread.

Other scientists on the study included Claire Fraser and Emmanuel Mongodin of the Institute of Genome Sciences at the University of Maryland School of Medicine; Christopher Miller of Miller and Associates Equine Practice in Brewster, N.Y.; Rodney Belgrave of Mid-Atlantic Equine Hospital in Ringoes, N.J.; and Rachel Gardner of B.W. Furlong and Associates in Oldwick, N.J.

Source: Rutgers University 

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University Research Advances Food Safety with Faster Listeria Test and Norovirus Vaccine

A new way of detecting deadly Listeria contamination in food and a vaccine for troublesome Norovirus are being reported by major research universities.

University of Georgia College of Engineering researchers report they have a new method for Listeria detection, and the Virginia-Maryland College of Veterinary Medicine at Virginia Tech announced it will evaluate a potential live oral vaccine for norovirus, which is the No. 1 cause of foodborne illness.

Listeriosis, an infection caused by eating food contaminated by the bacterium Listeria monocytogenes, is known for causing severe illness in children, pregnant women, newborns, the elderly, and people with compromised immune systems.

It is the third leading cause of death from foodborne illness, or food poisoning, in the United States. An estimated 1,600 people get sick each year and about 260 die, according to the Centers for Disease Control and Prevention (CDC).

At present, Listeria contamination in food products is identified only through molecular tests conducted in diagnostic laboratories on samples taken at specific control points during the manufacturing and distribution process.

Although very accurate, this method requires significant processing time, transportation of samples, and expensive skilled labor and equipment.

In a new study published in the Journal of The Electrochemical Society, UGA researchers introduce a rapid diagnostic method based on electrochemical biosensing principles.

Electrochemical biosensors are promising alternatives to molecular detection methods because of their ease of use, high specificity, sensitivity, and low cost, according to the researchers.

The UGA researchers use bacteriophages, viruses that infect and replicate within bacteria, as receptors to identify Listeria monocytogenes using an electrochemical sensor.

Meanwhile, Lijuan Yuan, professor of virology and immunology at the Virginia-Maryland College of Veterinary Medicine at Virginia Tech, announced the progress being made around a norovirus vaccine. It was developed by Indiana University’s John Patton and colleagues using the Rotarix rotavirus vaccine as a platform.

Using reverse genetics, they will insert a norovirus protein into Gene 7 of the rotavirus. The virus will then express the norovirus protein in the gut, inducing an immune response against norovirus.

Yuan’s Virginia Tech lab will evaluate the replication capacity, immunogenicity, and protective efficacy of the vaccine using gnotobiotic pig models of human rotavirus and norovirus infection and diarrhea. A gnotobiotic animal is one that has been specially raised to contain zero germs or bacteria so researchers can better study the effects of bacteria and viruses such as rotavirus and norovirus.

The CDC says norovirus as the leading cause of vomiting and diarrhea from acute gastroenteritis in the United States, resulting in 19 million to 21 million illnesses every year.

Norovirus tends to affect young children and the elderly the most. It’s responsible for about 24,000 hospitalizations and 925,000 outpatient visits for American children each year, according to the National Center for Biotechnology Information. Rotavirus also causes acute gastroenteritis and hits young children the hardest.

“Together, rotavirus and norovirus cause over 415,000 deaths every year, and norovirus also has a very significant burden even in the countries that don’t have a lot of deaths. The economic cost is huge, with $4.2 billion in direct costs and $60 billion in indirect societal costs. You hear about norovirus outbreaks on the news all the time in hospitals, nursing homes, and cruise ships and how it’s closing down restaurants, so it’s got a lot of economic implications,” said Yuan.

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PRESS RELEASE: Cepheid and BioGX Announce Collaboration to Develop Monkeypox PCR Test for the GeneXpert® System

Cepheid and BioGX announced a collaboration between the two companies to deliver a PCR test for Monkeypox that will run on the GeneXpert system. With a global installed base of over 40,000 GeneXpert systems in 180 countries, this test could be deployed quickly in multiple settings where actionable information is needed.

According to the Centers for Disease Control and Prevention (CDC), monkeypox is rare and does not spread easily between people without close contact. While the threat of monkeypox to the general U.S. population remains low (1), it is important for healthcare providers worldwide to have a preparedness plan. One of the key signs of infection with the virus is fever with development of a maculopapular rash, often appearing as small, raised spots. However, there are many other illnesses, such as chickenpox, measles, bacterial skin infections, syphilis, herpes, and medication-associated allergies that can present with similar symptoms. This underscores the need for a molecular test that can identify monkeypox. The World Health Organization recommends PCR as the preferred laboratory test for monkeypox, using an appropriate skin lesion sample (2).

"Our FleXible Cartridge program gives Cepheid the ability to work with external partners to develop accurate tests quickly when the need arises," said David H. Persing, M.D., Ph.D., Cepheid's EVP and Chief Scientific Officer. Beginning with Bacillus anthracis (Anthrax) and continuing with Mycobacterium tuberculosis, Influenza H1N1, Ebola virus and SARS-CoV-2 among others, Cepheid has a long history of quickly developing and delivering tests that address urgent public health issues as they emerge."

BioGX also has a successful track record of working with government agencies and diagnostic partners to quickly develop and manufacture at-scale molecular tests for detection of emerging pathogens.

"We previously collaborated on a project with the CDC to develop and manufacture a multiplex Monkeypox/Orthopoxvirus test for a GeneXpert-based study (3), and now with Cepheid we are moving to the validation stage utilizing the FleXible cartridge," said Michael Vickery, Ph.D., BioGX's EVP and Chief Scientific Officer. "Regional response teams need a PCR test that is fast and easy to implement when they suspect an outbreak due to a novel pathogen."

Product in development. Not for use in diagnostic procedures. Not reviewed by any regulatory body. Product in development is subject to change and specifications have not yet been established.

References:

1. https://www.cdc.gov/poxvirus/monkeypox/index.html

2. https://www.who.int/news-room/fact-sheets/detail/monkeypox

3. Li D., Wilkins K., McCollum A.M., Osadebe L., Kabamba J., Nquete B., Likafi T., Balilo M.P., Lushima R.S., Malekani J., et al. Evaluation of the GeneXpert for human monkeypox diagnosis. Am. J. Trop. Med. Hyg. 2017;96:405–410. doi: 10.4269/ajtmh.16-0567. - DOI  https://www.ajtmh.org/view/journals/tpmd/96/2/article-p405.xml

About Cepheid

Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. 

About BioGX

BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama and Dallas, TX, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively "BioGX"), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards. The proprietary Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing. BioGX's 60+ multiplex real-time PCR products are marketed and sold worldwide through its Global Distribution Network. 

Image credit: US Centers for Disease Control.

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PRESS RELEASE: New Antibody Detection Method for Coronavirus That Does Not Require a Blood Sample

Despite significant and stunning advances in vaccine technology, the COVID-19 global pandemic is not over. A key challenge in limiting the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is identifying infected individuals. Now, investigators from Japan have developed a new antibody-based method for the rapid and reliable detection of SARS-CoV-2 that does not require a blood sample.

The ineffective identification of SARS-CoV-2-infected individuals has severely limited the global response to the COVID-19 pandemic, and the high rate of asymptomatic infections (16%–38%) has exacerbated this situation. The predominant detection method to date collects samples by swabbing the nose and throat. However, the application of this method is limited by its long detection time (4–6 hours), high cost, and requirement for specialized equipment and medical personnel, particularly in resource-limited countries.

An alternative and complementary method for the confirmation of COVID-19 infection involves the detection of SARS-CoV-2-specific antibodies. Testing strips based on gold nanoparticles are currently in widespread use for point-of-care testing in many countries. They produce sensitive and reliable results within 10–20 minutes, but they require blood samples collected via a finger prick using a lancing device. This is painful and increases the risk of infection or cross-contamination, and the used kit components present a potential biohazard risk. 

Lead author Leilei Bao from the Institute of Industrial Science, The University of Tokyo, explains: “To develop a minimally invasive detection assay that would avoid these drawbacks, we explored the idea of sampling and testing the interstitial fluid (ISF), which is located in the epidermis and dermis layers of human skin. Although the antibody levels in the ISF are approximately15%–25% of those in blood, it was still feasible that anti-SARS-CoV-2 IgM/IgG antibodies could be detected and that ISF could act as a direct substitute for blood sampling.”

After demonstrating that ISF could be suitable for antibody detection, the researchers developed an innovative approach to both sample and test the ISF. “First, we developed biodegradable porous microneedles made of polylactic acid that draws up the ISF from human skin,” explains Beomjoon Kim, senior author. “Then, we constructed a paper-based immunoassay biosensor for the detection of SARS-CoV-2-specific antibodies.” By integrating these two elements, the researchers created a compact patch capable of on-site detection of the antibodies within 3 minutes (result from in vitro tests).

This novel detection device has great potential for the rapid screening of COVID-19 and many other infectious diseases that is safe and acceptable to patients. It holds promise for use in many countries regardless of their wealth, which is a key aim for the global management of infectious disease. 

The article, “Anti SARS CoV 2 IgM/IgG antibodies detection using a patch sensor containing porous microneedles and a paper based immunoassay,” was published in Scientific Reports.

About Institute of Industrial Science, The University of Tokyo

The Institute of Industrial Science, The University of Tokyo (UTokyo-IIS) is one of the largest university-attached research institutes in Japan. Over 120 research laboratories, each headed by a faculty member, comprise UTokyo-IIS, which has more than 1,200 members (approximately 400 staff and 800 students) actively engaged in education and research. Its activities cover almost all areas of engineering. Since its foundation in 1949, UTokyo-IIS has worked to bridge the huge gaps that exist between academic disciplines and real-world applications.

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PRESS RELEASE: MicroGenDX Provides Rapid Screening for Candida Auris to Help Avoid Outbreaks in Healthcare Settings

Candida auris causes serious infections, and cases are rising across the U.S as documented by CDC's tracking map. More than one in three patients die within a month of being diagnosed with a bloodstream or other invasive C. auris infection, and patients in hospitals and nursing homes are particularly susceptible.

MicroGenDX molecular testing overcomes current challenges with detecting C. auris. For example, both standard culture and MALDI-TOF have difficulty identifying this species of fungus, but MicroGenDX DNA analysis specifically targets C. auris using the internal transcribed spacer (ITS) region of its rDNA and is extremely accurate. MicroGenDX testing also facilitates the rapid intervention and precautions needed to prevent outbreaks in healthcare settings by returning results within 24-48 hours. The MicroGenDX test also accepts multiple sample types, including swab, tissue, and urine.

About MicroGenDX

Founded in 2008, MicroGenDX has become the industry leader in rapid turnaround and affordability for comprehensive Next-Generation Sequencing (NGS) and qPCR testing for clinical diagnostics. MicroGenDX is CLIA-licensed and CAP-accredited, and has been the trusted research partner for the CDC, U.S. Army, NASA, and the FDA. MicroGenDX has published over 70 clinical studies and is the most experienced molecular diagnostic laboratory with some 1.5 million samples processed.

References

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694398

https://www.cdc.gov/fungal/candida-auris/identification.html

https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html

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PRESS RELEASE: Spindiag declares CE-conformity for two new Rhonda PCR rapid tests for use at the Point of Care (POC)

Spindiag GmbH, an in-vitro diagnostics Start-up based in Freiburg/Breisgau, Germany, today announced that it has declared CE-IVD conformity for two new tests for its Rhonda PCR rapid testing system. The new Rhonda Respi disk allows the detection of SARS-CoV-2, Influenza A, Influenza B, and the Respiratory Syncytial Virus (RSV) with only one swab sample in well under one hour. A test to detect Methicillin-resistant Staphylococcus aureus (MRSA) was also CE-marked and complements the growing portfolio of the company, which currently commercializes its Rhonda system in Germany and Austria.

Dr. Daniel Mark, CEO and co-founder of Spindiag, said: “Point-of-care testing is becoming increasingly important for infection diagnostics. There is a high medical need for rapid, reliable tests that can be used in hospital emergency rooms to prevent the spread of infectious diseases caused by pathogens that are detected too late. I am very pleased that our Start-up once again demonstrated its innovative strength by launching two new PCR-tests at the same time. With the Respi test, healthcare professionals can now simultaneously detect four viral respiratory pathogens in less than one hour. For example, the SARS-Coronavirus-2 can be differentiated from an Influenza virus and targeted infection control measures can be taken immediately. While COVID-19 has put the focus on viral pathogens, we must not forget that antibiotic-resistant bacteria are a serious challenge for healthcare systems worldwide, as a recent Lancet study showed1. To address this challenge, we have developed our second new test: the Rhonda MRSA test reliably detects the resistant pathogen, and thereby protects vulnerable groups. Rapid and reliable detection can help slow down the spread of antibiotic-resistant bacteria in healthcare systems.“

Although most COVID-19 protection measures were lifted, testing still remains very important in healthcare facilities. Since face masks are not mandatory in public spaces any longer, respiratory pathogens can again spread more easily. Viral respiratory diseases have very similar symptoms and therefore require rapid decision-making at the point of care. The Rhonda Respi test allows this medical need to be met. COVID-19 has also exacerbated the situation for spreading of antibiotic-resistant pathogens, as bacterial co-infections can occur while having COVID-192. Rhonda enables hospital staff to take the right decisions simply and rapidly: the testing system combines speed with the reliability of PCR-testing. Pre-emptive isolation measures can thus be avoided, and vulnerable groups can be effectively protected from possible infections at the same time.

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PRESS RELEASE: First Patent Regarding RPIDD Infectious Disease Liquid Biopsy Technology DNA Library Preparation and Amplification Methods Granted

Aptorum Group Limited, a clinical-stage biopharmaceutical company, is pleased to announce that the US Patent and Trademark Office (“US PTO”) has granted the patent regarding the Rapid Pathogen Infectious Disease Liquid Biopsy Diagnostics (“RPIDD”) regarding the invention of an unbiased and simultaneous amplification method for DNA library preparation (US Patent No : US11,280,028 B1) to A*STAR institution, a Singapore based institution with whom Aptorum has an exclusive licensing agreement of the said technology. The RPIDD technology has been exclusively licensed by Aptorum from A*Star through its subsidiary, Aptorum Innovations Holding Pte Limited.

The RPIDD invention employs a unique method in preparing DNA libraries from samples which contain more than one type of nucleic acids in substantially low amount comparative to non-nucleic acid molecules in the sample within a remarkably shorter turnaround time and substantially more simplified steps compared to conventional methods of preparing DNA library.

Mr. Darren Lui, President and Executive Director of Aptorum Group Limited comments “Through our collaboration partner A*STAR, we are extremely delighted that the USPTO has recognised the uniqueness of our RPIDD technology and hence granted the said patent. The patented RPIDD method is going to revolutionize the traditional first line clinical diagnostics for infectious diseases such as blood culture, PCR (etc), and we are convinced that a rapid molecular liquid biopsy based diagnostics approach for infectious diseases will disrupt the current approaches and hence in due course potentially reduce infected patient’s mortality and morbidity. We are now spearheading the efforts in the ongoing clinical validation and pre-commercialisation preparation of our patented RPIDD.”

About Aptorum’s Rapid Pathogen Identification and Detection Diagnostics Technology (RPIDD)

RPIDD is an innovative liquid biopsy-driven rapid pathogen molecular diagnostics technology. Proprietary technologies are being developed to enrich pathogenic DNA / RNA for analysis through harnessing the power of Next-Generation Sequencing platforms and proprietary artificial intelligence-based software analytics with the goal to rapidly identify and detect any foreign pathogens (virus, bacteria, fungus, parasites) without bias through its genome composition and to identify other unknown pathogens and novel mutated pathogens. RPIDD has been and continues to be validated in human samples and so far, such testing has been able to detect pathogens – ranging from bacteria, fungi and viruses in an unbiased manner. RPIDD is currently under validation in-human.

About Aptorum Group Limited

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic assets to treat diseases with unmet medical needs, particularly in oncology (including orphan oncology indications) and infectious diseases. The pipeline of Aptorum is also enriched through (i) the establishment of drug discovery platforms that enable the discovery of new therapeutics assets through, e.g. systematic screening of existing approved drug molecules, and microbiome-based research platform for treatments of metabolic diseases; and (ii) the co-development of a novel molecular-based rapid pathogen identification and detection diagnostics technology with Accelerate Technologies Pte Ltd, commercialization arm of the Singapore’s Agency for Science, Technology and Research.

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Engineers Develop Fast and Accurate Covid Sensor

Engineers at Johns Hopkins University, supported in part by the U.S. National Science Foundation, have developed a COVID-19 sensor that addresses the limitations of the two most widely used types of COVID-19 tests: PCR tests that require sample preparation, and the less accurate rapid antigen tests.

The sensor technology, which is not yet available, is almost as sensitive as a PCR test and as convenient as a rapid antigen test. The simple-to-use sensor doesn’t require sample preparation and can be used as disposable chips or on a wide variety of surfaces.

“The technique is as simple as putting a drop of saliva on our device and getting a negative or a positive result,” said Ishan Barman, one of the senior authors of the study. “The key novelty is that this is a label-free technique, which means that no additional chemical modifications like molecular labeling or antibody functionalization are required. The sensor could eventually be used in wearable devices.”

“Label-free optical detection, combined with machine learning, allows us to have a single platform that can test for a wide range of viruses with enhanced sensitivity and selectivity, with a very fast turnaround,” added lead author Debadrita Paria.

“Using state-of-the-art nanoimprint fabrication and transfer printing, we have realized highly precise, tunable and scalable nanomanufacturing of both rigid and flexible COVID sensor substrates, important for future implementation, not just on chip-based biosensors but also wearables,” said senior author David Gracias.

The platform goes beyond the current coronavirus pandemic, according to Barman. “We can use this for broad testing against different viruses, for instance, to differentiate between SARS-CoV-2 and H1N1, and even variants. This is a major issue that can’t be readily addressed by current rapid tests.”

The team continues to develop and test the technology and is pursuing a patent and potential license and commercialization opportunities.

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A Rapid Graphene Sensor Platform for the Detection of Viruses in a Pinprick

Scientists at Swansea University, Biovici Ltd and the National Physical Laboratory have developed a method to detect viruses in very small volumes.

The work, published in Advanced NanoBiomed Research ("A Rapid Graphene Sensor Platform for the Detection of Viral Proteins in Low Volume Samples"), follows a successful Innovate UK project developing graphene for use in biosensors – devices that can detect tiny levels of disease markers.

For many parts of the world that do not have access to high-tech labs found in hospitals, detecting viruses such as hepatitis C (HCV) – could save millions of preventable deaths worldwide. In addition, biosensors such as this could be used at the point-of-care – opening effective healthcare in difficult-to-reach settings.

What makes the detection of viruses in such small volumes possible is the use of a material called graphene. Graphene is extremely thin - only one atom thick - making it very sensitive to anything that attaches to it. By carefully controlling its surface, scientists at Swansea University were able to make the surface of graphene sensitive to the HCV virus. These measurements were done with graphene specialists at the National Physical Laboratory.

In the future, it is hoped that multiple biosensors can be developed onto a single chip – this could be used to detect different types of dangerous viruses or disease markers from a single measurement.

Ffion Walters, Innovation Technologist at Swansea University’s Healthcare Technology Centre said: “Highly sensitive and simplistic sensors have never been more in demand with regards point-of-care applications. This collaborative project has allowed us to realise proof-of-concept real-time sensors for HCV, which could be especially beneficial in resource-limited settings or for difficult-to-reach populations.”

Professor Owen Guy, Head of Chemistry at Swansea University, said: “At Swansea University, we have now developed graphene-based biosensors for both Hepatitis B and C. This is a major step forward to a future single point of care test”

Dr Olga Kazakova, NPL Fellow Quantum Materials & Sensors added: “NPL was delighted to be part of this multidisciplinary team. Participation in this project allowed us to further develop our metrological validation facilities and apply them to the characterisation of graphene biosensors and aid in solving an important challenge in the health sector.”

Source: Swansea University

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PRESS RELEASE: Cepheid Receives Emergency Use Authorization for Xpert® Xpress CoV-2 plus

Cepheid announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress CoV-2 plus, a rapid molecular diagnostic test for qualitative detection of the virus that causes COVID-19.

Viruses constantly change through mutation and these mutations can give rise to new variants with unique characteristics. Multiple variants of the virus that cause COVID-19 have been documented globally during the pandemic. Cepheid is proactively addressing this increasing genetic diversity by enhancing gene coverage. The new plus version of the test incorporates a 3rd conserved genetic target for SARS-CoV-2 detection to meet the challenge of future viral mutations and optimizes nucleocapsid gene probes to enable consistent virus detection.

Xpert Xpress CoV-2 plus joins Xpert® Xpress CoV-2/Flu/RSV plus and others in Cepheid's growing portfolio of PCRplus respiratory tests that deliver rapid, accurate, and actionable respiratory results. Xpert Xpress CoV-2/Flu/RSV plus continues to be the most appropriate product for when multiple viruses that cause influenza-like illnesses are circulating. Xpert Xpress CoV2 plus is authorized to be used on any individuals, including for screening those without symptoms or reasons to suspect COVID-19.(1)

Xpert Xpress CoV-2 plus is designed for use on any of Cepheid's over 40,000 GeneXpert® systems placed worldwide. The test can provide rapid on-demand detection of SARS-CoV-2 in as soon as 20 minutes for positive results.(2)  

"From the beginning of the pandemic, we have been keenly focused on staying ahead of SARS-CoV-2 genetic drift and have designed our tests in anticipation of current and potential future variants." said David Persing, M.D., Ph.D., EVP, and Chief Scientific Officer. "The high sensitivity of this test is now especially important for recently announced Test-to-Treat initiatives, for which early detection is important for achieving the best clinical outcomes of antiviral therapies."

Xpert Xpress CoV-2 plus is expected to begin shipping to US customers in May.

1.  PPA and NPA for asymptomatic specimens were calculated using anterior nasal swab specimens.

2.  With early assay termination for positives only; reporting of negatives in approximately 30 minutes.

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FREDsense, Ginkgo Bioworks Partner to Make Water Quality Biosensors

FREDsense Technologies Corp, a water quality platform company, and Ginkgo Bioworks, a synthetic cellular biology company, today announced a partnership to build biosensors for water quality monitoring and detection.

Through this partnership, Ginkgo seeks to build four distinct microbial strain biosensors, compatible with FREDsense's field-ready hardware for remote water quality monitoring applications.

Water quality has become a growing environmental and public health concern, increasing the demand for scalable monitoring and testing systems. With conventional water quality tests, transporting samples to labs for chemical analysis can lead to lengthy delays in reporting. Some companies, like FREDsense, work to offer portable solutions that allow for rapid feedback without the need for external lab equipment.

"Water is our most critical resource, and we now have the technology to detect in real-time many of the threats or contaminants that can impact the water that our environments and communities depend on," says David Lloyd, CEO of FREDsense. "Through this partnership with Ginkgo, we aim to introduce rapid, simple, and accurate testing to deliver water quality monitoring systems to those that most need it. We believe that synthetic biology is the key to solving some of the biggest challenges facing the water industry globally and are very excited to partner with Ginkgo on this vision."

The biosensors in development by Ginkgo aim to enable real-time field detection of harmful molecules, and may be used to generate solutions for groundwater and industrial water management systems.

"Partnering with FREDsense is an exciting opportunity to apply Ginkgo's strain development capabilities to powerful biosensor technology for an important application," said Jason Kelly, CEO of Ginkgo Bioworks. "Protecting our water sources is a mission critical initiative: life on this planet as we know it depends on it. We're eager to work toward enhancing the capabilities of FREDsense's platform to monitor for harmful contaminants in water."

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Johns Hopkins Scientists Develop New Sensor for Rapid COVID-19 Testing

A new sensor developed by researchers at Hopkins can detect communicable diseases like COVID-19, H1N1 and the Zika virus in saliva more accurately than traditional rapid tests at about the same speed.

The sensor relies on a combination of surface-enhanced Raman spectroscopy (SERS), machine learning, and large-area nanoimprint lithography. Researchers believe the technology could potentially boost public health safety measures in crowded locations. 

The project began about two years ago, near the start of the COVID-19 pandemic. The researchers started with detecting SARS-CoV-2 as their primary goal, but their work eventually expanded to include other infectious diseases like Zika, H1N1 and the Marburg virus. The results were published earlier this spring in Nano Letters.

Ishan Barman is an associate professor of mechanical engineering with joint appointments in the Sidney Kimmel Comprehensive Cancer Center and the Russell H. Morgan Department of Radiology and Radiological Science. Barman is one of the senior authors of the paper and the principal investigator of the lab that created the sensor.

He discussed the project’s beginnings in an interview with The News-Letter.

“When the first wave [of COVID-19] hit, it was explosive enough; it was a problem of large enough significance that even if it hadn’t continued for as long as it has, it would still have been a problem worth solving,” he said. “At the end of the day, a crucial step in controlling outbreaks is the timely and accurate calculation of emerging viruses.”

Debadrita Paria is a postdoctoral fellow in the Barman Lab. In an email to The News-Letter, Paria noted that the process of making the sensor was complicated by pandemic restrictions.

“It required rigorous planning and execution. We used to have several Zoom meetings where several ideas would come up and then we would go to the lab and try to implement those and see what worked. Since we were working in shifts, we had to do the experiments in a limited timeframe,” Paria wrote.

While PCR and rapid antigen tests are currently used for SARS-CoV-2 detection, researchers have pointed out their limitations. PCR tests require intense sample processing, including the use of fluorescent markers, to detect if COVID-19 RNA is present in a sample. Rapid antigen tests lack accuracy and have been hard to find because of high demand. Another challenge, according to the paper published in Nano Letters, is storing and transporting samples to be processed. 

Barman described how the sensor aims to counter those drawbacks. 

“We were always thinking that we need better sensing technology that combines the salient features of what we know: RT-PCR, which has incredible sensitivity and specificity, with the convenience and speed of the rapid antigen test,” he said.

The new sensor relies on a saliva sample instead of a more invasive nasal swab. Additionally, its accuracy for detecting COVID-19 is around 92%, which is comparable to PCR, the current gold standard. Finally, the sensor can work quickly, giving a positive or negative test result in about 12 minutes, according to Barman. The lab plans to continue working on reducing that time. 

Additionally, the sensor has built-in flexibility for SARS-CoV-2 mutations, meaning it will still be able to identify new variants. The team’s next goals are to work on identifying and differentiating these variants and to test real patient samples with the sensor to gauge how well it operates.

There are three components to how the sensor works: nanoimprint lithography, SERS and machine learning. The nanoimprint lithography provides a flexible surface for the saliva sample, using a field enhancing metal insulator antenna array to amplify the signal for the spectroscopy. 

SERS reads the sample relying on inelastic scattering of light to characterize how unique molecules vibrate. If COVID-19 or another infectious disease is present in the sample, there will be characteristic vibration patterns on the spectroscopy readout. 

The sensor then utilizes machine learning to determine if new samples are positive or negative based on what previous positive spectroscopy readouts looked like. According to the paper, using machine learning allows greater sensitivity and specificity to help overcome the noise from other unwanted biological specimens in the saliva sample. 

According to Barman, it can be placed on doorknobs, masks and other locations to help facilitate on-site rapid testing because of the flexibility of the surface used for the sample. He noted that the portable device to be used in those instances is about two shoeboxes tall. 

Barman highlighted that the new viral sensor has potential to be used as mass-testing technology not only for COVID-19 but also for other pathogens such as influenza, Zika virus and the Marburg virus. 

“We wanted to create a tool that would be better at managing outbreaks in the future. Thinking beyond the pandemic was always an objective,” he said.

Source: The Johns Hopkins News-Letter. 

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Purdue Receives Grant for Pursuit of African Swine Fever Rapid Test

African swine fever, a highly contagious swine disease, is in the Dominican Republic. The disease does not infect people, but it can wipe out pork production in a region. Quick identification and containment are key to stopping its spread, and a team of Purdue University researchers are developing a rapid, pen-side test for the disease.

The National Animal Health Laboratory Network and the National Animal Disease Preparedness and Response Program has provided $1 million to Mohit Verma, assistant professor of agricultural and biological engineering at Purdue, for the project.

“A rapid test that can be done in the field is needed for surveillance and diagnosis of African swine fever,” he said. “When it hit China a few years ago, it wiped out 50% of the country’s pig population. It is a devastating disease, and hours, even minutes, matter in containing it.”

The research funding was included in the U.S. Farm Bill to build up the nation’s ability to quickly detect and respond to high-consequence diseases.

“This was the first time to my knowledge that a joint operation between these two organizations was included in the farm bill,” Verma said. “It shows how seriously the U.S. is taking the risk from African swine fever.”

Verma is collaborating with Purdue scientists Darryl Ragland, associate professor of veterinary medicine, and Jonathan Alex Pasternak, an assistant professor of animal sciences, to create a portable paper-strip test for the disease. The project follows in the footsteps of Verma’s success developing similar tests for COVID-19 and Bovine Respiratory Disease.

“We’re working on a test that will detect the virus within 30 minutes and indicate results through an easy-to-see color change on a paper strip,” Verma said. “The ease of use, test timing and size are similar to those of an at-home pregnancy test or COVID-19 test.”

A saliva or blood sample will be used for the test. Within a cartridge, the sample is mixed with primers and reagents developed by the team and gently heated. The included paper strip then changes colors if African swine fever DNA is present, he said.

“We want the test to be easy for farmers and veterinarians, and for the pigs,” Verma said. “Our hope is to create something affordable and accessible that could be broadly used in the U.S. and throughout the world.”

The technology tests for DNA from the virus and uses a method of nucleic acid amplification called loop-mediated isothermal amplification, or LAMP. When the viral DNA is present, LAMP amplifies it. As the level of nucleic acid increases, it changes the pH of the assay, which triggers the color change on the paper strip.

The advantage of LAMP over other methods is that it does not require extraction and processing of the samples, which can be lengthy and expensive, Verma said

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Massachusetts Institute Of Technology: 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.

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Rapid Lyme Disease Tests Could Soon Be Heading to A Doctor’s Office Near You

A faster test for Lyme disease with results in as little as an hour could be available in doctor’s offices in the near future thanks to the efforts of two UCF researchers.

Mollie Jewett, associate professor and head of the Immunity and Pathogenesis Division at the College of Medicine and Brian Kim an assistant professor in the College of Engineering and Computer Science, will split a $325,000 grant over two years from the Global Lyme Alliance to create a rapid test that can detect the disease weeks earlier than current tests allow. The new test would eliminate the need to visit diagnostic labs and wait for the results.

Lyme disease is carried by deer ticks and infects people when they are bitten by ticks carrying the bacteria borrelia burgdorferi.  Deer ticks are especially common in the northeastern United States and people are exposed to the ticks usually during outdoor activities. Warming temperatures have helped tick populations explode and infiltrate more areas of the country increasing the chance of getting the disease.

The Centers for Disease Control and Prevention estimate that 476,000 people are infected with Lyme disease every year.

Early symptoms of Lyme disease are fever, headache, fatigue and the possibility of a telltale bullseye rash at the site of the bite. If left untreated, the infection can spread to the joints, heart, and nervous system and cause debilitating long-term conditions.

“Testing is a real obstacle for patients, the longer the patient goes without treatment the higher the potential for significant persistent symptoms,” says Jewett.  “Lyme disease antibodies takes up to 14 days to become detectable. By directly detecting the bacteria that causes Lyme disease, the test will fill the current blind spot in the time from infection to diagnosis.”

When the infection is caught early and treated with antibiotics in the preliminary stages, patients can recover quickly without long-term effects. Patients who are treated in later stages of the disease tend to respond well to antibiotics, however, some continue to suffer from ongoing symptoms, termed Post-treatment Lyme disease Syndrome.

Jewett is creating a molecular test that can not only test for antibodies in the blood specific for the infection, but also directly detect the bacteria that causes Lyme disease. The hand-held diagnostic device which the researchers call the Lyme iDS, combines Jewett’s molecular test with Kim’s detection device.

“The science and technology behind the device can be applied to many diseases using biological fluids such as blood in the case of Lyme disease,” says Kim who has successfully applied his testing device for detecting HIV, Zika virus, tuberculosis and COVID-19. His goals are to make testing easier, faster and cheaper by building a device with less expensive components that performs as well as current more expensive and bulky instruments.

Griffith Parks, the College of Medicine’s associate dean of Research and director of the Burnett School of Biomedical Sciences, praised the collaborative research project.

“This is prime example of how two outstanding researchers can partner to address an important biomedical problem from new complementary points of view,” says Parks.

“We are excited to have faculty from the College of Medicine working closely with the strong faculty in the College of Engineering and Computer Science.”

Source: UCF News 

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