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U.S. medical device company wins FDA approval of 15-minute COVID-19 test

Becton Dickinson & Co. won a U.S. regulator’s approval for a portable COVID-19 test that delivers results in 15 minutes.

The Food and Drug Administration granted an emergency-use authorization for the BD Veritor Plus System, Franklin Lakes, New Jersey-based Becton Dickinson said Monday in a statement.

The hand-held product, which is around the size of a mobile phone, is part of a new class of antigen testing technology that promises to bring faster, cheaper testing to doctors’ offices, urgent-care centres and other medical facilities. The first such test, from Quidel Corp., was cleared for U.S. use in May.

“It’s a breakthrough technology for the battle of COVID,” Becton Dickinson chief executive officer Tom Polen said in an interview. The simplicity of the test design and procedure allows it to “be run in more routine settings, with less laboratory education and practice. It’s the most basic type of test people can run.”

The U.S. has been struggling with a shortfall of testing supplies and equipment since the coronavirus pandemic’s early weeks. The shortages have led to long lines for testing in new hot spots like Arizona, Texas and Florida, and threaten to undermine containment efforts as the nation sees record increases in reported cases of COVID-19.

Because of high demand for testing, average wait times for test results have swelled to 3 to 5 days for nonpriority cases, commercial lab Quest Diagnostics Inc. said on Monday. High-priority patients receive results after one day. Speedier answers allow those who test positive to quarantine faster, and assist public-health work like contact tracing that stems the virus’s spread.

Becton Dickinson’s new product runs on its Veritor Plus system, which is already used in more than 25,000 U.S. locations to detect strep throat and the flu. Manufacturing has already begun and shipping begins immediately. The company plans to produce up to 10 million tests by the end of September, and is working toward a capacity to manufacture 2 million a week.

The new antigen testing equipment is cheaper for medical facilities to buy and to use. Abbott Laboratories’ rapid ID NOW system, for instance, has a price tag in the thousands of dollars. Becton Dickinson’s Veritor Plus System has an average selling price of $250 to $300 (U.S.), and the tests themselves are about $20 each, Polen said. Quidel’s test could cost as little as $5 to administer, former FDA Commissioner Scott Gottlieb has said.

“People keep saying ‘For that, I want to buy one for my house,’” Polen said. The FDA clearance, however, requires the test be used in facilities that meet certain regulatory requirements.

Questions about accuracy, which have dogged even the diagnostic tests that are considered the gold standard for COVID-19, also arise with antigen tests. The Becton Dickinson product surpasses the FDA’s requirement for 80 per cent accuracy, Polen said, though he declined to provide further specifics.

Antigen tests “may not detect all active infections,” the FDA said in May. “This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection.”

The results may also require another diagnostic test “prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative,” the FDA said.

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