Roche To Launch Rapid COVID-19 Test In Europe This Month, Seek FDA Emergency Use Approval

Roche Holding AG RHHBY said Tuesday it will launch a COVID-19 rapid antigen test in late September in Europe and intends to file for emergency use authorization (EUA) in the United States.

What Happened: The 15-minute test is to be used in point of care settings for both symptomatic and asymptomatic people, the company said in a statement.

The test has a sensitivity of 96.52% and a specificity of 99.68%, Roche claims. The company said it intended to make 40 million testing units available per month initially in the countries which accept CE marking.

The pharmaceutical giant plans to ratchet up production of the tests by two-fold at the end of 2020.

Roche is launching the SARS-COV-2 rapid test in partnership with SD Biosensor Inc. The two companies jointly launched another rapid antibody test earlier in July.

The Swiss drugmaker's CEO, Thomas Schinecker, said testing was of importance due to the upcoming flu season.

“It is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment,” Schinecker said.

Why It Matters: Roche says it has a portfolio of 10 diagnostic and management solutions related to COVID-19 through testing in both laboratory and point of care and through various phases of disease progression.

The multinational pharmaceutical company has received FDA EUA for some of its COVID-19 diagnostics tests.

Last month, Abbott Laboratories ABT received an EUA for a $5 COVID-19 test, which is said to detect the disease in 15 minutes.

XpresSpa Group Inc XSPA also struck a deal with Abbott to use its ID NOW tests for COVID-19 testing at major airports such as JFK International and Newark.

Price Action: Roche OTC shares closed nearly 1.8% higher at $44.50 on Tuesday.

Photo courtesy: Raimon Spekking via Wikimedia