As first OTC COVID-19 test raises stakes for consumer guidance, Abbott opts for prescription path
The rise of at-home COVID-19 testing highlights trade-offs between scalability and control
FDA’s first authorization of an over-the-counter, at-home COVID-19 antigen test marks a major step in the intersection of individual self-monitoring and public health, and ups the ante on communicating uncertainty around results. Abbott’s home test, authorized Wednesday, brings a narrower indication but higher volume.
Brisbane-based Ellume Ltd., which submitted an application for emergency use authorization (EUA) on Nov. 9, received authorization for its COVID-19 antigen test Tuesday.
The EUA allows the test to be sold without a prescription and used in any individual over the age of two, regardless of whether there is reason to suspect they might be infected.
On Wednesday, FDA expanded the reach of the point-of-care BinaxNOW antigen test from Abbott Laboratories (NYSE:ABT) by extending its EUA to include home use.
Yet like the first FDA-authorized at-home COVID-19 test from Lucira Health Inc., home use of BinaxNOW requires a prescription, and is only indicated for individuals suspected of having COVID-19 by their healthcare provider. The indication is further limited to individuals within the first seven days of symptom onset.
BinaxNOW, which has the largest production capacity of any COVID-19 antigen test, has been heavily deployed by the Trump Administration in government-supported testing programs. The company plans to deliver and administer 30 million at-home tests in 1Q21 and another 90 million in 2Q21; in contrast, Ellume is targeting delivery of 20 million tests to the U.S. market in 1H21.
In opting for a prescription path, facilitated by digital health partner eMed, Abbott faces less uncertainty about how individuals will interpret and act on test results than it would in an over-the-counter setting.
Over-the-counter access to COVID-19 testing will be a key catalyst in the move toward broad asymptomatic screening to facilitate travel and in-person gatherings. But taking healthcare providers out of the equation makes it all the more important that manufacturers and regulators clearly communicate the possibility of false positives and negatives, a step FDA took when it announced Ellume’s EUA.