A rapid assay for COVID-19 testing
Veravas shares news of a 10-minute oral testing option for SARS-CoV-2 infection
CHARLESTON, S.C.—Veravas Inc., an early-stage biotechnology company, has announced the development of its VeraTest SARS-CoV-2 Rapid Antigen Assay, which is based on its 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. With this assay, which is intended for use by CLIA laboratories as well as at mobile CLIA laboratories, more than 500 results can be reported per hour with a commercially available 96-well plate imager, and more than 2,000 results per hour can be reported with automation, facilitating rapid, large-scale and location-based SARS-CoV-2 antigen testing.
“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,” Carroll E. Streetman, Jr., CEO of Veravas, said in a press release. “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.”
In early studies, this test has proven capable of specifically detecting 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. The assay has also 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.
“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,” noted Dr. Gerald McInerney, antibody fragment co-developer. McInerney is also associate professor of Virology at the Karolinska Institute and co-founder of Vicunab AB.
Veravas has agreed to an exclusive global license from Vicunab for use of the antibody in diagnostics and its assay.
The performance of the assay is currently being evaluated by Access Genetics, LLC dba OralDNA Labs as well as at a U.S.-based Academic Center of Excellence, using the BioTek Cytation 5 Cell Imaging Multi-Mode Reader.
Veravas reports that its current capacity will allow it to manufacture 30 million tests per month, with plans to scale up to more than 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 more than 1,000 tests per hour, per unit.
SOURCE: Veravas press release