Weavr Health (formerly Boston Microfluidics), a diagnostics company, has submitted a request to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for the Silk COVID-19 Rapid Antibody Test.

Once authorized, the test could be the first rapid, at-home COVID-19 antibody test, enabling testing for IgG and IgM antibodies with results in as little as 10 minutes.

Antibody testing is used to identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Earlier this year, Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases and advisor to the White House Coronavirus Task Force, suggested that antibody levels can be used to help determine when vaccine protection wanes – information that will be critical as booster shots become available1. More research in the coming months will clarify the importance of antibodies to immunity.

Silk is a lateral flow test that uses a fingerstick blood draw, the same non-invasive procedure used for blood glucose monitoring, to offer the convenience of a rapid, at-home test with high levels of sensitivity. The EUA request is for distribution and/or use for self-testing in non-healthcare settings by individuals 18 years or older as well as in point of care settings.

“We designed our test to provide results at home, and with its built-in fingerstick capability users can see results in as few as 10 minutes – no phlebotomist or lab involved,” said Linh Hoang, M.D., Ph.D., CEO of Weavr Health. “Studies suggest antibodies are correlated with lower risk of future infection2. If additional data show antibodies are important in gauging immunity, the need for a booster shot, or other purposes, at home testing options will be critical for access, scalability, and convenience.”

The company’s EUA submission includes data from its prospective clinical study of 254 subjects, assessing the test’s ability to qualitatively differentiate and detect IgG and IgM antibodies to SARS-CoV-2 spike and nucleocapsid proteins in human fingerstick whole blood.

Source: Company Press Release