Tuesday, June 21, 2022

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

Monday, June 20, 2022

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.

Saturday, May 14, 2022

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.

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.

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

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.

Tuesday, April 19, 2022

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."

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

Saturday, March 05, 2022

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