Roche Diagnostics has launched its first test using its new high-throughput technology that enables users of Roche's Cobas analyzers to simultaneously test for 12 respiratory viruses, including influenza A and B, RSV, and the COVID-19 virus in a single patient sample.
The Cobas Respiratory Flex test -- designed for the high-throughput Cobas 5800, 6800, and 8800 molecular diagnostic analyzers -- uses Roche's new proprietary Temperature-Activated Generation of Signal (TAGS) technology. TAGS uses multiplex polymerase chain reaction (PCR) testing in conjunction with color, temperature, and data processing to identify as many as 15 pathogens in a single PCR test, Roche explained in a statement.
"Many respiratory illnesses share similar symptoms, making them difficult to diagnose. As respiratory outbreaks, combined with growing incidence of antibiotic resistance continue, getting an accurate and timely diagnosis is critical to providing the best care for patients and curbing transmission," Matt Sause, CEO of Roche Diagnostics, said.
"Using TAGS technology, the Cobas Respiratory Flex test can help clinicians identify specific respiratory viruses sooner, helping to speed up diagnosis and get the right care to patients," Sause said.
The Cobas Respiratory Flex test offers qualitative detection and differentiation of influenza A and B; RSV; adenovirus; human metapneumovirus; enterovirus/rhinovirus; parainfluenza 1, 2, 3, and 4; coronavirus (229E, OC43, NL63, HKU1); and SARS-CoV-2 in nasopharyngeal swab specimens from patients with symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.
The new test is currently available in countries that accept the CE Mark. U.S. Food and Drug Administration 510(k) submission is planned for the fourth quarter of 2024, according to Roche; multiple countries around the world have initiated their local registrations.
