Roche Introduces First Test Using TAGS Technology for Detecting 12 Respiratory Viruses
Tuesday, September 24, 2024
Roche has introduced the cobas® Respiratory flex test, which is the first to use its proprietary TAGS (Temperature-Activated Generation of Signal) technology.
The cobas® Respiratory flex test can detect up to 12 common respiratory viruses, including influenza A and B, Respiratory Syncytial Virus (RSV), and SARS-CoV-2, from a single patient sample.
This technology allows for the detection of up to 15 pathogens in a single PCR test, significantly expanding the typical four results achievable with standard PCR tests.
The test is designed for use on Roche's cobas® 5800, 6800, and 8800 molecular diagnostic analysers, facilitating syndromic panel testing. This is especially valuable when similar symptoms could indicate different pathogens.
Clinicians can customise the test to focus on specific pathogens depending on the season, region, or patient circumstances. This flexibility enables a more targeted diagnostic approach, reducing the need for follow-up testing and speeding up the diagnostic process. The test can generate results instantly, without the need for a new sample or rerunning tests, improving laboratory efficiency.
By providing comprehensive results in one PCR test, the cobas® Respiratory flex test reduces the need for multiple test kits, simplifying laboratory operations.
The test is currently available in countries that recognise the CE mark, with submissions for regulatory approval in other regions, including a planned submission to the U.S. FDA in Q4. Roche's TAGS technology offers further potential in detecting various pathogens and could be a breakthrough for high throughput infectious disease testing.
The TAGS technology enables the detection and differentiation of up to 15 diagnostic results per well by distinguishing up to three targets per fluorescence channel. This technology overcomes the limitations of previous four-plex tests and can be used immediately with existing cobas® systems, allowing labs to deliver rapid, accurate, and flexible syndromic multiplex PCR testing.
This follows recent developments, including FDA emergency use authorisation for the cobas® liat test, which enables rapid multiplex testing for SARS-CoV-2, Influenza A/B, and RSV in urgent care settings. Roche continues to expand its range of diagnostic solutions, catering to both large laboratories and smaller healthcare facilities.
Source: roche.com