Roche launches test for parallel, high throughput detection of multiple respiratory viruses

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Roche announced the launch of the cobas Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology. TAGS technology uses multiplex polymerase chain reaction (PCR) testing, combined with colour, temperature and data processing, to identify as many as 15 pathogens in a single PCR test. This would enable syndromic panel testing on the high throughput molecular diagnostic analysers cobas 5800, 6800 and 8800, which is especially important when a common group of symptoms can be related to more than one pathogen.

The cobas Respiratory flex test runs on the cobas 5800, 6800 and 8800 systems. The cobas Respiratory flex test offers qualitative detection and differentiation of Influenza A & B, Respiratory Syncytial Virus (RSV), Adenovirus (AdV), human Metapneumovirus (hMPV), Enterovirus/Rhinovirus (EV/RV), Parainfluenza 1, 2, 3 & 4, Coronavirus (229E, OC43, NL63, HKU1), and SARS-CoV-2 in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.

The cobas Respiratory flex test can detect up to 12 of the most common respiratory viruses, including influenza A, influenza B, Respiratory Syncytial Virus (RSV) and SARS-CoV-2, within a patient sample using a single PCR test. The test is now available in countries accepting CE-mark, and multiple countries around the world have initiated their local registrations. The U.S. 510(k) clearance from FDA will follow with submission planned for Q4. Additionally, the TAGS technology has potential across multiple types of pathogens and indications, offering the chance to revolutionise high throughput testing for infectious diseases in future.