FDA Grants Emergency Use Authorization to Roche’s Cobas Liat SARS-CoV-2, Influenza A/B, & RSV Nucleic Acid Test

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The FDA has granted Emergency Use Authorization (EUA) to Roche’s cobas liat SARS-CoV-2, Influenza A/B & respiratory syncytial virus (RSV) nucleic acid test. According to the company, it is a four-in-one molecular test, defined as an automated multiplex RT-PCR assay that can detect SARS-CoV-2, influenza A, influenza B, and RSV from a nasal swab sample. Additionally, Roche reported that full results can be expected in 20 minutes via a compact analyzer.¹

“Diagnostics play a critical role in the fight against respiratory illness,” said Matt Sause, CEO, Roche Diagnostics, in a press release. “We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.”

Currently, testing with the cobas liat is restricted to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, meaning that they meet the requirements to perform high, moderate, or waived complexity tests. The test is also cleared in patient care settings under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Roche stated that testing with the cobas liat will lead to expedited clinical decision-making, a reduction of unnecessary antibiotic use, enable targeted treatments, and enhance overall patient outcomes and healthcare efficiency. Moving forward, the company intends to apply for FDA 510(k) clearance and CLIA waiver for 2025, with aspirations of a global commercial launch following CE-IVDR approval.¹

In March, the FDA also approved the cobas test to screen for Malaria in potential blood donors. Roche stated that the test can reduce the risk of malaria transmission through blood transfusions. The test screens blood samples for five species of Plasmodium parasites, making it the first of its kind approved for this purpose.^2,3

“As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood," said Sause, in a press release. “The approval of cobas Malaria represents a significant advancement in malaria detection, offering healthcare professionals a reliable tool for donor screening and improving the safety of patients worldwide.”

According to the Centers for Disease Control and Prevention (CDC), hospitalizations for COVID-19, flu, and RSV saw a decline back in February; however, positive flu tests increased in some parts of the country, with hospitalization rates increasing as a result.⁴

“As we saw last season, COVID-19, flu, and RSV account for a large proportion of hospitalizations for respiratory viruses during the fall and winter months. This season, flu and RSV illnesses started increasing later in the fall, which is more like what we typically saw before the pandemic,” reports the CDC.

Regardless of the time of year, the CDC recommends getting vaccinated for COVID-19, flu, and RSV. This past season, only 22% of adults received the COVID-19 vaccine, which includes 42% of those 65 years of age or older and considered to be at a higher risk of severe disease. Additionally, around 48% of adults received a flu vaccine, and only 22% of adults over the age of 60 years have received an RSV vaccination.⁴

“Testing to determine the cause of respiratory symptoms can help inform recommendations about the most appropriate treatment. Tests, including at-home tests for COVID-19, can detect these respiratory viruses so patients can better understand their illness and take next steps. Prescription treatments are available for both COVID-19 and flu,” the CDC continues. “Other tools that can help prevent the spread of COVID-19, flu, and RSV include masking, physical distancing, washing hands, and improving airflow in the places where people live and work.”

References

1. Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA Emergency Use Authorization. Roche. June 10, 2024. Accessed June 11, 2024. https://www.roche.com/media/releases/med-cor-2024-06-10b

2. FDA Approves Roche’s Cobas Malaria Test, Designed to Screen for Malaria in Potential Blood Donors. Pharm Exec. March 27, 2024. Accessed June 11, 2024. https://www.pharmexec.com/view/fda-approves-roche-s-cobas-malaria-test-designed-to-screen-for-malaria-in-potential-blood-donors

3. Roche receives FDA approval for the first molecular test to screen for malaria in blood donors. Roche. March 26, 2024. Accessed June 11, 2024. https://www.roche.com/media/releases/med-cor-2024-03-26

4. 2023-2024 Respiratory Virus Season Is Likely Past Peak but Far from Over. CDC. February 16, 2024. Accessed June 11, 2024. https://www.cdc.gov/ncird/whats-new/2023-2024-season-not-over.html