Roche has introduced the cobas Respiratory flex test, a new diagnostic that utilises the company’s temperature-activated generation of signal (TAGS) technology.
This is said to be the first instance of TAGS technology application in a test, which is capable of identifying up to 15 pathogens in a single polymerase chain reaction (PCR) test.
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The test can detect 12 common respiratory viruses, including influenza A and B, Respiratory Syncytial Virus (RSV), and SARS-CoV-2.
Developed by Roche scientists, the TAGS technology enhances PCR tests on high throughput analysers such as cobas 5800, 6800, and 8800, allowing them to identify three times the number of results typically possible. This is particularly beneficial for syndromic panel testing, where a group of symptoms may be caused by multiple pathogens.
The cobas Respiratory flex test enables clinicians to tailor testing by selecting specific pathogens based on various factors, including the test setting and patient characteristics.
With digital reflex technology, the test can generate additional results instantly without requiring a new sample or retesting.
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By GlobalDataThe test is now available in countries that accept the CE mark, and efforts are underway to register the product in multiple countries worldwide. The US Food and Drug Administration (FDA) 510(k) clearance is anticipated following a submission planned for the fourth quarter.
Roche’s TAGS technology facilitates the differentiation of up to three targets per fluorescence channel, leading to the detection and differentiation of up to 15 diagnostic results per well from a single test kit.
This advancement addresses the limitations of previous 4-plex tests and can be implemented without the need for hardware or software upgrades in existing cobas systems.
Roche Diagnostics CEO Matt Sause 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.”
The cobas Respiratory flex test is designed to detect and differentiate a range of respiratory viruses in nasopharyngeal swab specimens from patients exhibiting respiratory infection symptoms, in line with clinical and epidemiological risk factors.
In July 2024, Roche completed the acquisition of LumiraDx’s Point of Care technology for up to $350m.
