Dive Brief:

• Qiagen has filed for emergency use authorization with FDA for a test designed to detect SARS-CoV-2 antigens designed to deliver positive results in two minutes and determine a sample is negative in 15 minutes.

• Competitors such as Abbott, BD and Quidel all currently sell antigen tests that deliver results in 15 minutes. Like the tests from BD and Quidel, Qiagen's test runs on an instrument.

• Qiagen claims 90% sensitivity and 100% specificity for the QIAreach SARS-CoV-2 Antigen Test but is yet to share details of its assessment of the diagnostic. Other antigen tests including those sold by Abbott, Roche and Quidel have claimed sensitivities of around 97%.  

Dive Insight:

COVID-19 antigen testing has become a big business as the pandemic has progressed. BD reported $340 million in sales from its Veritor antigen platform in the fourth quarter and tipped the system to generate up to $1.5 billion next year. Quidel made $318 million from its Sofia SARS Antigen test in its most recent set of financials. 

Quidel had the market to itself for almost two months over the summer but now has six competitors, with Roche and Qiagen awaiting EUAs for their antigen kits. Qiagen is planning to enter the market with a product it thinks has some advantages over the competition. 

The instrument, which was developed with Qiagen partner Ellume, is battery powered and can handle up to eight samples. Qiagen said each instrument can perform more than 30 tests an hour. 

BD and Quidel's instruments analyze one specimen at a time, although samples do not need to be in the machine for 15 minutes. Rather, users can allow the test to develop outside the instrument for 15 minutes and receive a result within one minute of inserting the cartridge into the device. 

Qiagen's instrument can also run the QIAreach Anti-SARS-CoV-2 Antibody Test. That flexibility could increase the utility of the instrument if, as companies including Roche expect, antibody testing rises as COVID-19 vaccines come to market. Qiagen unveiled the antibody test in August, at which time it said it had filed for EUA and would begin shipments later that month. FDA is yet to add the test to its list of EUAs. Qiagen said the test had 100% sensitivity and specificity in a study to support EUA.

The antigen and antibody test will add to the growing arsenal of COVID-19 diagnostics. A standing committee of the National Academies of Sciences, Engineering, and Medicine issued a report on the range of diagnostics and the testing strategies they enable earlier this week. The report called for the evaluation of antigen tests and other diagnostics in the field to ascertain if the 90%-plus sensitivities and specificities seen in contrived studies are replicated in the real world.

There is a mounting body of evidence that real-world performance may fall short of the specificities and sensitivities claimed by companies. A University of Arizona study cited by the New York Times found Quidel's antigen test was less effective in the field, particularly when used on asymptomatic individuals, and a paper published in The BMJ Wednesday showed Abingdon Health’s antibody test underperformed in the real world.