(Reuters) – Abbott Laboratories Inc said on Wednesday it would begin shipping a new coronavirus blood test that can tell whether a person has ever been infected and plans to ramp up manufacturing to produce 20 million tests per month by June.
The test helps identify disease-fighting antibodies in people who have been infected but may have had mild symptoms or none at all, making it different from the current diagnostic tests that require nasal swabs to confirm active infection.
Antibody tests are considered a potential game changer in the battle to contain infections and offers the chance to get the economy back on track by identifying people who may have immunity to the virus and could return to their jobs. (https://reut.rs/2RFgway)
The test from Abbott is being launched under the U.S. Food and Drug Administration’s recently relaxed rules for coronavirus tests, allowing the distribution of some tests before they receive regulatory clearance.
The company expects to ship close to 1 million tests this week to hospitals and labs in the United States, and will ship a total of 4 million tests in April.
Abbott’s test identifies the IgG antibody, a protein that the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered.
The company said it plans to file for FDA approval for its test through the emergency use pathway and would work on expanding its testing to detect the antibody, IgM, made by the body a few days after infection.
Abbott has previously won U.S. authorization for two coronavirus testing kits: an automated test that can be used in labs and a test that can deliver results within minutes and be used in physicians’ offices, clinics and hospitals.
Wells Fargo Securities analyst Larry Biegelsen said the antibody test provides an additional boost to Abbott’s diagnostic business, with the potential to bring in monthly revenue of about $100 million by June if each test is priced at around $5-$6.
Shares of the medical device maker, slated to report first-quarter results on Thursday, were up 3% at $91.82 in late morning trading.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shailesh Kuber)