FDA authorizes new Roche test for identifying high-risk COVID-19 patients

Roche received an emergency authorization from the FDA for a new type of coronavirus diagnostic test—not to confirm an active infection or previous exposure to the disease, but to help identify whether a person with COVID-19 has a high risk of developing severe complications. 

The Big Pharma’s Elecsys test measures levels of the immune system biomarker interleukin 6, or IL-6, found in the bloodstream; it has been previously used in Europe to help screen people who may suffer from severe sepsis and inflammation following trauma or major surgery.

Now, Roche says the test’s results can help give clinicians advanced warning for those who may enter respiratory failure and require a ventilator. 

“In the current situation, time is specifically critical,” said Roche Diagnostics CEO Thomas Schinecker. “The test could help physicians in the quick identification of severe inflammatory response in patients infected with the SARS CoV-2 virus.”

The test is designed to provide a result in less than 20 minutes, while running up to 300 samples per hour on Roche’s cobas lab equipment.

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IL-6 is released by immune cells early in response to viruses, bacteria and other stimuli, and can trigger fevers and other defenses. It also plays a role in the potentially fatal cascade of immune system proteins known as cytokine release syndrome, when the body overreacts to an intruder. Severe cases of COVID-19 have shown the hallmarks of these cytokine storms, alongside deadly pneumonia. 

Roche’s Actemra (tocilizumab) targets IL-6 and was approved in 2017 to treat cytokine release syndromes brought on by the administration of CAR-T immune cell therapies in the treatment of cancer. In mid-March, the drugmaker launched a phase 3 study evaluating Actemra’s use in COVID-19 patients, and later began ramping up its production in April.