Beckman Coulter plans to launch a $4 coronavirus antigen test designed for mass screening, with the goal of shipping up to 25 million per month by March.
The Access antigen assay is designed for high-throughput laboratory hardware and can deliver individual results in 30 minutes while processing up to 200 samples per hour. The company said it is currently submitting the test to the FDA for emergency review.
In addition, the $4 price tag holds for all healthcare providers—as well as public and private institutions such as schools, businesses, government agencies and nonprofit organizations—to help encourage repeated COVID-19 screenings.
"To test the masses and test them frequently, we need an affordable, reliable and scalable solution,” said Beckman Coulter’s chief medical officer, Shamiram Feinglass.
In addition, Beckman Coulter said its lab-based test can be more sensitive and easier for screening large volumes of people compared to the rapid, hand-held antigen tests that may have to be run one at a time.
“A point-of-care test that delivers a result in 15 minutes for a single individual cannot perform as efficiently when it’s asked to deliver results for larger populations; the workflow breaks down with too many manual steps in the process,” Feinglass said. “Furthermore, a hospital must report positive results to regulatory bodies, and many [point-of-care] tests require cumbersome manual recording of patient data into their [electronic medical record].”
However, the trade-off includes potentially delayed results due to the time needed to ship samples to a centralized testing laboratory for analysis. Beckman Coulter said its nasopharyngeal swabs can be stored at room temperature for 24 hours and refrigerated for 48 hours during transport.
The antigen assay has been shown to agree with positive results from molecular-based PCR tests 93% of the time and with negative results 100% of the time when used within seven days of the first symptoms.
Following authorization from the FDA, the company said it can immediately begin shipping 18 million tests monthly in the U.S.; Beckman Coulter also plans to make the test available in Europe under a CE mark in January.