Saliva-based, high-throughput rapid antigen assay reportedly detects SARS-CoV-2 with similar sensitivity and specificity as PCR in only 10 minutes.
CHARLESTON, S.C. (PRWEB) SEPTEMBER 24, 2020 – Veravas, Inc. an early-stage biotechnology company, has announced the development of its VeraTest™ SARS-CoV-2 Rapid Antigen Assay, based on their patent-pending VeraPrep™ technology and a proprietary novel antibody fragment with high specificity to the SARS-Cov-2 spike protein. The 10-minute assay is easily performed with a saliva sample, sample diluent and a single VeraPrep-based assay reagent. Intended for use by CLIA laboratories as well as at mobile CLIA laboratories, over 500 results can be reported per hour with a commercially-available 96-well plate imager, and over 2,000 results per hour can be reported with automation, facilitating rapid, large-scale and location-based SARS-CoV-2 antigen testing.
In early studies, the assay technology has been shown to specifically detect SARS-CoV-2 in PCR confirmed positive oral saline rinse samples with similar sensitivity as PCR. The novel alpaca-derived, single-domain antibody binds with high affinity and specificity to the SARS-CoV-2 spike protein, making it an ideal molecule for a rapid antigen test. To date, the assay has been able to correctly read PCR confirmed positive saliva samples as positive with Ct values as high as 37, and correctly read PCR negative saliva samples as negative. Higher PCR Ct values indicate a smaller amount of viral material in a given sample, signaling a more sensitive test.
Antibody fragment co-developer, Dr. Gerald McInerney, Associate Professor of Virology, Karolinska Institute, Stockholm, Sweden, and Co-founder of Vicunab AB, stated, “A rapid test is required to address the global COVID-19 testing crisis and help societies safely emerge from lockdowns. We are happy our antibody is an important component of the VeraTest rapid antigen assay.” Veravas has agreed to an exclusive global license from Vicunab for use of the antibody in diagnostics and its assay.
“Veravas is very pleased to announce the development of a novel rapid antigen test for the detection of SARS CoV-2 infection from saliva samples in 10 minutes” stated Carroll E. Streetman, Jr, CEO of Veravas, Inc. “This fast, easy to sample, inexpensive, and highly specific and sensitive antigen test will assist healthcare providers and laboratories to quickly and reliably determine whether a patient is actively infected with the COVID-19 virus. Most importantly, this test will rapidly assess if it is safe for people to return to work, return to school, travel and go about their daily lives. Plans are to commercialize this novel antigen test in Q4-2020 following FDA review and Emergency Use Authorization.”
The performance of the assay is currently being evaluated by Access Genetics, LLC dba OralDNA® Labs in Eden Prairie, MN, and at a US-based, Academic Center of Excellence, using the BioTek Cytation 5 Cell Imaging Multi-Mode Reader.
Veravas reports current capacity to manufacture 30 million tests per month, with plans to scale to over 100 million tests per month by January 2021. The company also plans to supply its own fast, small plate imager, delivering a turnkey full solution for single-click results at the rate of over 1,000 tests per hour, per unit.
Vicunab has been incorporated by Leo Hanke, Benjamin Murrell, and Gerald McInerney, developers of a unique alpaca-derived, single-domain antibody fragment that was shown to neutralize SARS-CoV-2 by blocking receptor interaction. Vicunab is based in Stockholm, Sweden.
Veravas, Inc. is a biotechnology company focused on transforming the practice of laboratory medicine with technology that delivers superior test results, providing confidence to clinicians and patients that diagnostic tests when performed are accurate. Veravas’ nanobead technology, VeraPrep™, can identify, remove, and measure select substances from patient samples to reduce the effects of complex interferences and detect low abundance biomarkers. In response to the global health priority for COVID-19 countermeasures, Veravas is utilizing its VeraPrep technology to develop novel COVID-19 testing solutions and continues to rapidly drive the commercialization of its proprietary sample preparation products and diagnostic tests. To learn more about the company’s technologies and clinical applications, visit http://www.veravas.com