Inside the Lab Industry

Abbott and Quidel Stake Out Early Claims for Leadership of SARS-CoV-2 Rapid Antigen Testing Market

What COVID-19 antigen assays lack in accuracy with regard to RT-PCR testing is offset by their speed, low cost and scalability. In the long term, these advantages make point-of-care COVID-19 antigen testing a potential 9-, 10- or even 11-figure opportunity in the years to come. And now two of the industry’s biggest companies have staked their claims to lead that market. Here’s a look at what appears to be shaping up as a massive rivalry between Abbott Laboratories and Quidel for control of COVID-19 antigen testing.

The Promise of Antigen Testing

Testing the symptomatic is currently the immediate priority. But once case rates decline, the long term and sustainable opportunity created by the pandemic is the need for rapid point of care tests that can deliver accurate results at cost-effective prices for use in screening asymptomatic populations. RT PCR molecular tests performed at an offsite lab aren’t suited to meet this need.  Blood-based serology tests that detect SARS-CoV-2 antibodies are better suited for widespread and rapid screening, but lack the specificity and sensitivity of RT PCR assays.

Antigen tests that detect viruses indirectly—by identifying the presence of antigens or toxins a virus produces—are relatively inexpensive to produce and generate results rapidly at the point of care. And while its relative lack of sensitivity creates the risk of false negatives and need for confirmatory testing, antigen testing may still be appropriate for applications like screening health care workers and other high-risk groups and triaging patients during peak outbreak periods.

Industry Response: Quidel Strikes First but Abbott Strikes Back

Developers and manufacturers of rapid antigen tests have declared that they’re ready, willing and able to meet this demand for increased testing. On May 8, the FDA granted the first Emergency Use Authorization (EUA) for a SARS-CoV-2 antigen test to Quidel’s Sofia 2 SARS Antigen FIA rapid point-of-care test run on the firm’s Sofia 2 analyzer.

On Aug. 26, Abbott upped the ante by securing EUA for its own SARS-CoV-2 antigen test, BinaxNow COVID-19 Ag Card providing test results readable without the use of an analyzer. The $5 test provides results in 15 minutes from a nasal swab that’s twirled on a test card with a testing reagent added. The results can be read directly from the card, like a pregnancy test, with one line indicating a negative result and two lines indicating a positive result.

On Dec. 16, Abbott consolidated its advantage by announcing that the FDA expanded EUA for BinaxNow for virtually guided at-home use. Costing $25 and delivering results in 15 minutes, the BinaxNow uses a digital health platform from telehealth company eMed to facilitate delivery of the test to homes and guide the collection and testing process, as well as Abbott’s own Navica app to display test results. Abbott indicated that it expects to deliver and administer 30 million tests in the first quarter of 2021, ramping up to 90 million in Q2.

Just two days later, Quidel secured EUA for its own readerless test, the QuickVue SARS Antigen test that delivers point-of-care results within 10 minutes via display of a colored line like a pregnancy test. Quidel said that it expects to ramp up QuickVue manufacturing to 600 million tests per year by the end of 2021.

Takeaway

Although SARS-CoV-2 point-of-care antigen testing is still in its formative stages, BinaxNow and QuickVue have emerged as the chief rivals—the Coke and Pepsi of the market. Both offer rapid results without the use of an analyzer. It’s unclear which test enjoys the edge in accuracy. Quidel says that QuickVue has a sensitivity value of 96.6 percent and a specificity of 99.3 percent based on 194 test samples. These results are pretty much in line with the 97.1 percent sensitivity and 98.5 specificity Abbott initially reported for BinaxNow. However, those results were based on just 102 samples. After Abbott expanded the study to 460 samples, sensitivity fell to 84.6 percent and specificity remained at 98.5 percent.

 

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