Roche starts OTC sales of COVID-19 test in first push into US market

Dive Brief:

Roche has begun over-the-counter sales of its at-home COVID-19 rapid antigen test in the U.S.
With the government stopping its free test program, which distributed the Roche product, the Swiss company has pivoted to commercial retail channels.
CVS, Amazon and the Optum Store are stocking the product, rebranded Pilot, marking the first time that Roche Diagnostics has distributed an OTC test in the U.S.

Dive Insight:

Roche was one of the companies that responded to the Biden Administration’s call for additional antigen tests last winter, securing a deal to contribute to the push to provide 1 billion free tests nationwide. Still, the surge in the availability of free at-home tests was short lived and the failure to secure further funding caused the suspension of the program at the start of September.

COVID-19 test sales at Roche have fallen since the government ended the program, sliding from $1.9 billion in the first quarter to $600 million in the third quarter. In response, Roche is pivoting to new channels.

The product now on U.S. pharmacy shelves is the same test that received emergency use authorization late last year and is rebranded as Pilot. SD Biosensor, the Korean company that manufactures the antigen test, received a revised EUA letter for the Pilot COVID-19 At-Home Test earlier this year.

Roche and SD Biosensor evaluated the test in a clinical study at five sites in the U.S. The study used the test on 158 samples, 44 of which were positive. Compared to a PCR test, the assay achieved a sensitivity of 93.2% and specificity of 100%, indicating that, like other rapid antigen tests, Pilot has a small risk of delivering false negative results.

The OTC launch of the product will provide a test of the commercial appetite for COVID-19 tests. The Centers for Disease Control and Prevention continues to recommend people use an at-home COVID-19 test if they have any COVID-19 symptoms, were exposed to someone with the disease or are going to an indoor gathering. A four-pack of Roche’s test costs $48 at Optum, although it is insurance eligible.