Roche wins U.S. nod research for COVID-19 antibody

Roche wins U.S. nod research for COVID-19 antibody, aimed at improving performance

Roche (ROG.S) has earned U.S. approval for the emergency. Food and Drug Administration (FDA) for an antibody check to determine if the coronavirus has ever affected people, the Swiss drugmaker said on Sunday. Thomas Schinecker, Head of Diagnostics at Roche, said the company is aiming at more than doubling test volume from around 50 million a month to significantly more than 100 million a month by year-end.

Governments, companies, and people are searching for blood testing of this type to discover who may have had the disease, who may have some immunity, and hopefully to build plans to help end national lockdowns. Roche, based in Basel, which also carries out molecular tests to recognize active COVID-19 infections, said that its antibody test has a specificity rate of over 99.8 percent and 100 percent sensitivity, indicating that tests will produce very few false positives and no false negatives.

A false-positive outcome could lead to the incorrect inference that somebody has immunity. Roche said their research is based on intravenous blood samples, with greater precision than finger-prick tests.

Companies including U.S .- based Abbott Laboratories (ABT.N), Becton Dickinson (BDX.N), and Italy's DiaSorin (DIAS.MI) have also developed similar antibody tests. Abbott said his test's accuracy and sensitivity were 99.5 percent, and 100 percent, respectively. Diasorin said their Liason XL test has sensitivity of 97.4 percent and specificity of 98.5 per cent.

When demand for antibody tests escalates, an number of distributors with no history or proven testing expertise have also entered the seasoned companies in an all but unregulated marketplace in the United States. Roche has not disclosed a price for its research, but has said it will be the same worldwide.