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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