Roche joins race to make coronavirus antibody tests17 Apr, 2020
The Basel-based company said on Friday it wants to make the antibody test available by early May in countries that accept European CE regulatory standards, and is seeking U.S. Food and Drug Administration emergency authorization for its use in the United States. It plans by June to boost test production to “high double-digit millions” per month, said Thomas Schinecker, Roche’s diagnostics head.
Roche joins a global race in which U.S.-based Abbott Laboratories and Becton Dickinson and Co, Italy’s DiaSorin and others hope to sell tests that demonstrate people’s immune systems have developed antibodies in response to the new coronavirus.
While it is not yet known for sure if those who have been infected develop immunity to the new virus as with many other illnesses, accurate antibody tests are seen as essential to help nations craft strategies to end business and travel shutdowns that have battered economies around the globe.
Roche’s test, which differs from the PCR assays it also makes that use a nose swab to identify active infections, will run on more than 40,000 of its cobas e testing machines installed worldwide. It will identify immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies. The body quickly produces IgM antibodies for the initial fight against infection. IgG antibodies remain longer in the body, suggesting possible immunity.