Roche's COVID-19 Test Gets FDA's Emergency Use Authorization

Roche RHHBY announced today that the FDA has issued an Emergency Use Authorization (EUA) for the Elecsys IL-6 test.

The test will measure levels of the biomarker interleukin 6 (IL-6) and enables identification of patients with confirmed COVID-19 disease, who could be at high risk of intubation with mechanical ventilation.

Interleukin 6 (IL-6) is an early indicator of acute inflammation to aid in the management of critically ill patients.

The test will help physicians, along with other parameters, to decide early if a patient with confirmed COVID-19 illness requires mechanical ventilation.

The company has a strong diagnostics portfolio and the approval of additional tests will further bolster the same.

In March, Roche received the FDA’s EUA for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19. This is also available in countries accepting the CE Mark. Last month, the company announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received the FDA’s EUA and is available in markets accepting the CE mark.

Roche’s stock has gained 8.1% in the year so far against the industry’s decline of 1.2%.

Apart from the diagnostic tests for the identification of patients, Roche is evaluating Actemra/RoActemra for the treatment of COVID-19 patients.

The company has initiated COVACTA, a global phase III randomized, double-blind, placebo-controlled clinical trial, to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.

Roche has also initiated a late-stage study on Actemra/RoActemra in combination with Gilead Sciences’ GILD remdesivir in hospitalized patients with severe COVID-19 pneumonia.

Given the alarming levels of spread and severity of the virus, many companies are developing drugs/vaccines or testing their approved drugs to determine if they are effective in treating infected patients.

Eli Lilly LLY recently announced that patients have been dosed in its study of a potential antibody treatment designed to fight COVID-19. Meanwhile, Alexion ALXN is evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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