FRAMINGHAM – Kephera Diagnostics announced today, August 5, it has been approved as a CLIA certified laboratory by the Massachusetts Department of Public Health and the U.S. Centers for Medicare and Medicaid, and is now offering COVID-19 antibody testing in Massachusetts and 44 other states.
Kephera will use an ELISA (Enzyme-Linked Immunosorbent Assay) test that it developed in-house, which is based on the company’s research and identification of hyper-reactive viral epitopes.
Kephera’s test will help people know whether they were infected with COVID-19, which is critical information to help them make the safest decisions for their health and community.
Following the launch, Kephera will work with the FDA to facilitate the agency’s review of the test for an EUA (Emergency Use Authorization) designation.
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The clinical implications of a positive antibody test and to what extent previous exposure to COVID-19 leads to immunity from re-infection are currently topics of intense research. Because a large fraction of COVID-19 infections are asymptomatic, many people do not seek out a nasopharyngeal swab test which diagnoses active infection.
So those experiencing asymptomatic infection might not learn whether they had been exposed, and might have exposed others, without taking an antibody test, which determines whether a person has been infected with the virus at some point.
“We are very excited to launch our CLIA laboratory service today with our new test for COVID-19 antibodies” said Dr. Andrew Levin, Kephera’s Chief Executive Officer. “Antibody testing is an important part of the solution to the unmet need for COVID-19 testing, which is growing more urgent as the pandemic continues. Kephera will offer fast turnaround (48 to 72 hours) with a highly accurate assay that has been several months in development. This is the first among several new assays planned for release that will measure COVID-19 antibody features with diagnostic and prognostic significance.”
Kephera Diagnostics is a young and growing diagnostics company that aims to address the public health challenges of global infectious diseases with new point of care assay technology. Its mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis. Kephera was recently funded for development of new tests for several infectious diseases of
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