Becton Dickinson and Co.’s Covid-19 test, which provides results within 15 minutes, has been approved for use in countries that accept European CE marking, the diagnostics manufacturer announced on Wednesday.
The test is part of a new class of faster screening tools named for the proteins that identify them, known as antigens, that are detected on the surface of SARS-CoV-2. Becton Dickinson is expected to begin sales of the test, which will run on the company’s cell phone-sized BD Veritor Plus system, in European markets in late October. It is likely used by emergency rooms, general practitioners, and pediatricians.
“It really is a groundbreaking introduction here in Europe,” said Fernand Goldblat, BD’s director of diagnostics in Europe. Europe was really at the epicenter of the pandemic in April and May. “And unfortunately I think we are going back in that direction. So the need will be extremely high,” he said.
Antigen tests have proven to be a valuable tool because they produce results much faster than gold standard PCR diagnostic tests. However, they are generally less accurate. For example, in the United States, instructions for the BD system recommend that negative results be confirmed by a molecular test procedure.
Becton Dickinson said his antigen assay was 93.5% sensitive, a measure of how often infections are correctly identified, and 99.3% specific to the rate of correct negative tests. The data, which differs from the US label’s 84% sensitivity and 100% specificity, comes from a new clinical study recently submitted to the US Food and Drug Administration, said spokesman Troy Kirkpatrick.
Rapid antigen testing has arrived in Europe, and US-based Roche Holding AG announced this month that it will be launching its own 15-minute antigen test for European markets that accept the CE mark. Another test developer, LumiraDx, received the CE mark for its antigen test late last month. It is planned to produce 2 million tests in September and even 10 million in December.
Becton Dickinson’s Veritor System has so far been used primarily for flu screening in Europe, but the new test could help increase acceptance of antigen testing, including for influenza and other respiratory viruses, Goldblat said.
The company is currently in discussions in several European countries, mainly with governments and health authorities, about “where and how our solutions would fit,” he said.
The test is already available in the USA. Becton Dickinson said it is on track to produce around 8 million monthly in its global markets through October and 12 million monthly through March 2021.
Goldblat declined to comment on how these tests would be distributed in Europe and the US, with the exception that “a good part” would come to Europe. Pricing will depend, among other things, on the commitments made and the reimbursement environment in a particular country, he said.
In the United States, where regulators approved the test in July, the Veritor Plus system has an average retail price of $ 250 to $ 300, and the tests themselves cost about $ 20 each.
(Except for the headline, this story was not edited by GossipMantri staff and posted from a syndicated feed.)