Abbott gets CE mark to sell COVID-19 antigen test directly to consumers in Europe

Dive Brief:

Abbott Laboratories on Monday said its Panbio COVID-19 antigen test received CE marking and is approved for sale directly to consumers in Europe in adults and children with or without symptoms.
The self-test, which provides results in about 15 minutes with no instrumentation, is similar to Abbott's BinaxNOW over-the-counter coronavirus antigen test sold in the United States through retailers including CVS, Walgreens and Walmart. Panbio is not available in the U.S., where Abbott manufactures and sells BinaxNOW instead.
The CE mark for Panbio "paves the way for critical access to fast, reliable self-testing throughout Europe," Abbott said in a written statement. However, the test missed half of COVID-19 cases in asymptomatic people, according to a study run by the Irish healthcare system published earlier this month.

Dive Insight:

Abbott is betting that frequent rapid COVID-19 testing at work, school and home are critical to enabling European economies to fully reopen and to allow daily life activities to resume. With CE mark approval for the direct-to-consumer Panbio, the diagnostics maker is hoping to quickly get the antigen tests rolled out to European countries for use on symptomatic or asymptomatic adults and children, including infants with an adult's help.

CEO Robert Ford in an interview last month with CNBC said that Panbio is a similar test to BinaxNOW and that its respective manufacturing capabilities in Europe and the U.S. for both antigen tests is about the same.

"We manufacture [Panbio] outside the United States and we supply those to international markets. And we have just as much capacity in those manufacturing sites than the sites we built here in the US ... We can do about a 150 million tests per month if we need to," Ford said.

Since August 2020, Abbott said it shipped 300 million Panbio rapid antigen tests for professional use in Europe, the Americas, Asia and Africa.

The self-test was already authorized for use in France and Germany as part of national testing programs in schools, universities and workplaces, according to Abbott. The company contends that in clinical evaluations of Panbio, performed by healthcare professionals, the test correctly identified 98.1% of positive specimens and 99.8% of negative specimens, as confirmed by an approved PCR test.

In clinical evaluations of self-test users of Panbio, Abbott maintains the test correctly identified 95.2% of positive samples and 100% of negative samples.

However, the finding earlier this month of Ireland's Health Service Executive (HSE), which is in line with the results of a U.K. study of a rival test sold by Innova, led the Irish healthcare system to recommend against using single, standalone antigen kits for the purposes of asymptomatic screening.

The study assessed the use of seven rapid antigen products to test symptomatic people and one kit to evaluate asymptomatic individuals. HSE found that using Abbott's Panbio test to analyze self-collected nasal swabs detected 41 of the 79 cases picked up by PCR, resulting in a sensitivity of 51.9%.

HSE also evaluated rapid antigen tests from companies including Abbott, LumiraDx and Roche in symptomatic patients, concluding that variation in the performance of the kits means they should not be considered interchangeable.