Veravas is seeking an EUA for its saliva-based Covid-19 antigen test, which uses an antibody fragment derived from alpaca antibodies
A new saliva-based Covid-19 antigen test will produce results in ten minutes and allow labs to process 500 tests every hour, according to its developer Veravas.
The early-stage biotechnology company said its VeraTest SARS-CoV-2 Rapid Antigen Assay – which uses an antibody provided by Vicunab AB – detected the virus that causes Covid-19 in saline rinse samples with similar sensitivity as PCR in its testing.
Intended for use by CLIA (Clinical Laboratory Improvement Amendments) laboratories, as well as at mobile CLIA laboratories, Veravas said 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 technology that automates the process.
Veravas CEO Carroll E Streetman Jr said: “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.
“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 commercialise this novel antigen test in Q4 2020 following FDA review and Emergency Use Authorisation.”
Alpacas provide critical reagent for Veravas Covid-19 test
The antibody fragment used in the test is derived from antibodies discovered in alpacas that have the capacity to block virus entry at an early step of infection – a development that is also being researched for its treatment potential for the most at-risk Covid-19 patients.
According to Veravas, this 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.
Antibody fragment co-developer and Vicunab AB co-founder Dr Gerald McInerney said: “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 agreed to an exclusive global license from Vicunab for use of the antibody in diagnostics, and its new antigen test.