Not done yet: Roche nets new FDA COVID-19 authorization for point-of-care PCR screening test

Roche
For the first quarter of this year, Roche’s point-of-care and molecular testing divisions posted sales gains of 281% and 86%, respectively, compared to the first three months of 2020. The new Liat authorization combines both. (Roche)

Though the demand for COVID-19 testing is beginning to wind down, Roche is looking to make the most of what’s left, with a new molecular test designed to help healthcare workers track the pandemic over the long haul.

The company’s cobas Liat coronavirus test is its first real-time RT-PCR diagnostic—newly authorized by the FDA—for use at the point of care and for screening people with and without symptoms of the infection.

The small, automated Liat system, short for laboratory in a tube, is designed for emergency rooms and primary care clinics as well as doctors' offices and screening locations. The cartridge-based test is designed to deliver a result within 20 minutes and offers connections to Roche’s surveillance program for tracking emerging SARS-CoV-2 mutations. 

The COVID diagnostic will also be available in Europe under a CE mark, alongside its U.S. launch slated for next month, Roche said. The Liat system also runs separate tests for influenza, respiratory syncytial virus, strep and C. diff infections. 

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Over the course of 2020 and the spread of the pandemic, Roche’s diagnostics division saw its sales grow 14%, bringing in about $15.3 billion over the full year as COVID demands more than outweighed the losses stemming from lockdowns and deferred routine health screenings.

The cobas Liat system (Roche)

But for the remainder of 2021, test makers and analysts expect the market to continue to dry up—and potentially faster than market-watchers first thought, based on the success of national vaccination efforts.

Earlier this month, Abbott rolled back its sales projections by as much as $2 billion for the year after the Centers for Disease Control and Prevention said fully vaccinated people could forgo testing before traveling and routine screening—and even skip a test in some situations after being exposed to a close contact with COVID-19, as long as that person was not showing symptoms.

RELATED: Abbott takes an ax to sales forecast as COVID testing dries up faster than expected

Abbott had been expecting much slower declines in the need for its card-based, portable BinaxNow antigen test, with the bulk of its 2021 revenue expectations tied to long-term COVID surveillance and screening. But over April and May, as vaccination rates rose and daily new cases dropped by more than 60%, a sharp decline in sales for rapid diagnostics followed.

Earlier in the year, Roche’s diagnostics division posted 55% growth for the first quarter compared to the first three months of 2020, amounting to about $4.7 billion—with its point-of-care and molecular testing divisions posting the biggest gains at 281% and 86%, respectively. 

Since the beginning of the pandemic, Roche has launched both lab-based and point-of-care versions of PCR, antibody and antigen tests for COVID-19 in addition to research-use-only assays and diagnostics for guiding care.