Antigen testing has become a valuable tool because it produces results much faster.
Becton Dickinson and Co.’s Covid-19 test, which returns results in 15 minutes, has been cleared for use in countries that accept CE marking from Europe, the diagnostics maker said on Wednesday.
The test is part of a new class of faster screening tools named for identifying proteins called antigens that they detect on the surface of SARS-CoV-2. Becton Dickinson plans to start selling the test, which runs on the cellphone-sized BD Veritor Plus system, in European markets at the end of October. It will likely be used by emergency departments, general practitioners and pediatricians.
“It really is a game-changing introduction here in Europe,” said Fernand Goldblat, BD diagnostic manager for Europe. Europe was really at the epicenter of the pandemic in April and May, “and unfortunately I think we’ve turned back in that direction. So the need will be extremely high,” he said.
Antigen testing has become a valuable tool because it produces results much faster than standard PCR diagnostic tests. However, they are generally less precise. In the United States, for example, the BD System instructions recommend that negative results be confirmed by a molecular test method.
Becton Dickinson said his antigen test is 93.5% sensitive, a measure of how often he correctly identifies infections, and at 99.3% specific, the rate of correct negative tests. The data, which differs from the U.S. label’s 84% sensitivity and 100% specificity, comes from a new clinical study that was recently submitted to the U.S. Food and Drug Administration, the carrier said. lyrics by Troy Kirkpatrick.
European incursions
Rapid antigen testing has made headway in Europe and the United States, Roche Holding AG announced this month that it will launch its own 15-minute antigen test in European markets accepting CE marking. Another test developer, LumiraDx, received CE mark for its antigen test at the end of last month. He said he plans to manufacture 2 million tests in September and up to 10 million in December.
Becton Dickinson’s Veritor system has been widely used to screen for influenza in Europe to date, but the new test could help broaden adoption of antigen testing, including for influenza and other respiratory viruses, Goldblat said. .
The company is currently having conversations in several European countries, largely with governments and health authorities, about “where and how our solutions would fit,” he said.
The test is already available in the U.S. Becton Dickinson said it is on track to produce around 8 million per month by October in its global markets, and 12 million per month by March 2021.
Goldblat declined to comment on how these tests would be allocated in Europe and the United States, except that a “good chunk” would be sent to Europe. Pricing will depend on the commitments made and the repayment environment in a given country, among other factors, he said.
In the United States, where regulators cleared the test in July, the Veritor Plus system has an average selling price of $ 250 to $ 300, and the tests themselves cost around $ 20 each.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
