FDA alerts on false positives for Becton Dickinson COVID-19 test

Shares of Becton Dickinson & Co. BDX, +2.22% were down 0.7% in premarket trading on Tuesday, the day after the Food and Drug Administration issued an alert about an increased risk of false-positive results for one of BD’s COVID-19 diagnostic tests. In one study, 3% of the results were false positive for the BD Max System test, which received an emergency use authorization from the regulator in April. “Consider any positive result presumptive from tests using the BD SARS-CoV-2 Reagents for the BD Max System,” the FDA said. “Consider confirming with an alternate authorized test.” A spokesperson confirmed that BD had received reports of the false-positive results, saying that “the elevated rates represent a small subset of the positive results” and that the company is in discussions with the FDA about the issue. On Monday, BD had announced the launch of a point-of-care COVID-19 antigen test that can detect the coronavirus in 15 minutes, the third of its COVID-19 diagnostic test. BD’s stock is down 7.9% since the start of the year. The S&P 500 SPX, has declined 1.5% year-to-date.

https://www.marketwatch.com/story/fda-alerts-health-care-providers-about-false-positives-for-one-of-bds-covid-19-tests-2020-07-07