Roche has launched the cobas Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology. It is able to detect up to 12 of the most common respiratory viruses with the flexibility for targeted testing.
TAGS technology, developed by Roche scientists, 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.
Typically, PCR tests on a high throughput analyser can identify four results in a single test - TAGS technology makes it possible to increase this number to fifteen. This will 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.
“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,” said Matt Sause, CEO of Roche Diagnostics. “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.”
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 can 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. This simplifies laboratory logistics, helping to optimise the use of resources and reduce pressure on labs. The test is now available in countries accepting CE-mark, and multiple countries around the world have initiated their local registrations. The US 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.