Roche Receives FDA Emergency Approval To Ship 400,000 Coronavirus Test Kits Across US

Roche Holding AG RHHBY is shipping COVID-19 test kits approved under emergency use authorization (EUA) by the FDA.

What Happened

Roche’s Sars-CoV-2 Test for COVID-19 has begun shipping to hospitals and laboratories across the U.S. The test will enable high-volume, automated patient testing, the company said in a press release.

The first shipment was made last Friday, and the distribution is due to be completed this week. An additional 400,000 tests per week will be sent to 30 laboratory testing sites across the U.S. set up to carry out testing on an immediate basis under the Food and Drug Administration (FDA) emergency guidelines.

The EUA guidelines authorize the use of Roche’s test for the detection of COVID-19 in patients who match clinical or epidemiological criteria and is done by swabbing the back of the nose or throat. 

Why It Matters

The test is run on Roche’s fully automated cobas 6800 and cobas 8800 systems and has the capacity to process 384 results (cobas 6800) and 960 results (cobas 8800) in an eight-hour shift.

The cobas SARS-COV-2 Test is not FDA cleared or approved and can only be used for the duration of the coronavirus emergency under the EUA. The FDA can revoke or terminate the authorization at any time.

Other firms, too, are gearing up to ship COVID-19 tests. On Monday, Decision Diagnostics Corp.,DECN announced it would provide 200,000 kits across the U.S. and EU before summer, while on the same day Precheck Health Services Inc. HLTY announced its third distributing agreement to ship COVID-19 polymerase chain reaction PCR tests to Panama.

At the beginning of March, Co-Diagnostics Inc. CODX announced it would start providing COVID-19 tests to U.S. Clinical Laboratory Improvement Amendments or CLIA labs, which are laboratories that regulate testing.

Price Action

On Monday, Roche OTC shares closed 7.36% lower at $37.33. The company’s shares closed 3.6% higher at $302.76 in Zurich.