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Dive Summary:
- The FDA said Friday that it granted emergency use authorization to the first serological test designed to detect neutralizing antibodies in people previously infected with SARS-CoV-2.
- While neutralizing antibodies can block infection, previous AUS have been issued during the pandemic for serological tests that detect only the type of antibodies that do not necessarily decrease viral infection.
- The new evidence is from Chinese biotech GenScript, whose Hong Kong-listed shares plunged in September after it was revealed that Chinese customs was investigating the company for alleged violations of import and export regulations. GenScript is the parent company of Legend Biotech, known for its partnership with Johnson & Johnson to develop a treatment for multiple myeloma and whose initial U.S. public offering in June was one of the largest biotech IPOs of the year.
Dive Insight:
Antibodies that neutralize SARS-CoV-2 are being studied as a possible way to prevent infection, but the relationship to immunity is not yet clear. How long Antibodies persist after infection is also unknown, the FDA noted in its letter to GenScript granting authorization for the CPass SARS-CoV-2 Neutralizing Antibody Detection Kit. Patients should not assume immunity based on the results of serological tests, and the tests should not be used to diagnose a current infection, the agency stressed.
The FDA said it has issued US to more than 50 serological tests to detect the presence of antibodies. The number of antibody tests issued to commercial developers has accelerated in recent months, with 27 clearances granted in September and October alone. The first point-of-care version of an antibody test, a product from China’s Assure Tech that returns results in 15 minutes from just a few drops of blood, received an EUA in late September.
Abbott, Beckman Coulter, DiaSorin, Roche, Siemens Healthcare Diagnostics, and Thermo Fisher Scientific are among the latest companies to obtain USA for antibody testing. Abbott Chief Executive Robert Ford told analysts in a call last month that the antibody tests have not generated the level of demand the company initially hoped to see, but predicted that interest would increase once the tests are implemented. vaccines against coronavirus.
Siemens has claimed that antibody tests are key to monitoring the spread of the pandemic and can be used to help verify the effectiveness of vaccines when available.
Rainer Blair, Director of Parent company of Beckman Coulter Danaher said in last month’s earnings call that COVID-19 antibody tests could play a critical role both before and after vaccination for population surveillance and clinical trial studies, despite their relatively use. currently limited.
However, the category of tests was criticized early in the public health emergency when the agency allowed self-validating tests on the market without a US submission and the accuracy of which was subsequently questioned. The tests are also inappropriately promoted for diagnostic use.
In May, the FDA revised its approach to requiring developers of commercial antibody tests to submit an EUA, although they can still distribute the tests as long as an EUA is being prepared. The agency also began recalling inaccurate tests. It revoked two USAs for antibody testing over the summer, from Autobio Diagnostics and Chembio Diagnostic Systems, after determining that the products may be ineffective.
