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, developed by Roche scientists, uses multiplex polymerase chain reaction (PCR) testing, combined with color, temperature and data processing, to identify as many as 15 pathogens in a single PCR test. This will enable syndromic panel testing on the high throughput molecular diagnostic analyzers cobas 5800, 6800 and 8800.
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 also allows clinicians to specify which pathogens to look for using pre-selected targets. With this, clinicians are able to factor in the test setting, season, locality and patient-specific factors. For example, a clinician might use a targeted test in the winter months to find out if a typically healthy adult patient has influenza or SARS-CoV-2 when those particular respiratory viruses are prevalent. Typically, when clinicians assess a certain group of targets first, diagnosis can be delayed if follow-up tests are needed. Through digital reflex, the cobas Respiratory flex test removes that delay by enabling the generation of additional results instantly or within seconds and without having to collect another sample or to run the existing sample again.
Delivering comprehensive results in a single PCR test, the cobas Respiratory flex test avoids the need for multiple test kits.
The test is now available in countries accepting CE-mark. The U.S., 510(k) clearance from FDA will follow with submission planned for Q4.
