Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced the launch of its new cobas® Respiratory flex test, the first to incorporate Roche’s proprietary TAGS (Temperature-Activated Generation of Signal) technology. This innovative technology, developed by Roche scientists, enhances multiplex polymerase chain reaction (PCR) testing by combining color, temperature, and data processing to detect up to 15 pathogens in a single test. Traditional PCR tests typically identify only four pathogens in one run, but with TAGS technology, this capability is significantly expanded. This advancement supports syndromic panel testing on high-throughput molecular diagnostic systems like cobas® 5800, 6800, and 8800, which is crucial when multiple pathogens may be responsible for similar symptoms.
“Many respiratory illnesses present with overlapping symptoms, making accurate diagnosis difficult,” said Matt Sause, CEO of Roche Diagnostics. “With the ongoing risk of respiratory outbreaks and rising antibiotic resistance, timely diagnosis is essential. The cobas Respiratory flex test, powered by TAGS technology, enables faster detection of specific viruses, improving patient care and reducing transmission.”
The cobas Respiratory flex test can identify up to 12 common respiratory viruses, including influenza A, influenza B, respiratory syncytial virus (RSV), and SARS-CoV-2, from a single patient sample. The test also allows clinicians to target specific pathogens based on factors such as the test setting, season, and local virus trends. For instance, during winter, a clinician could focus on diagnosing influenza or SARS-CoV-2 when these viruses are more prevalent. By leveraging digital reflex technology, the test can instantly generate additional results without requiring new samples or retesting.
The cobas Respiratory flex test streamlines the diagnostic process, reducing the need for multiple test kits and simplifying laboratory operations. It is already available in countries accepting CE-mark approval, with further international registrations underway. U.S. FDA clearance is expected following a 510(k) submission planned for Q4. The TAGS technology also holds promise for broader applications, potentially transforming high-throughput infectious disease testing in the future.
TAGS (Temperature-Activated Generation of Signal) Technology
Roche’s TAGS technology allows the detection of up to 15 diagnostic targets per well by differentiating up to three targets per fluorescence channel. This breakthrough overcomes the previous limitation of detecting only four targets in one test. Laboratories using the cobas 5800, 6800, and 8800 systems can immediately benefit from this high-throughput, flexible syndromic PCR testing without requiring hardware or software upgrades.
cobas Respiratory flex test
The cobas Respiratory flex test operates on Roche’s cobas 5800, 6800, and 8800 systems, providing qualitative detection of multiple respiratory viruses. These include Influenza A & B, RSV, Adenovirus, human Metapneumovirus, Enterovirus/Rhinovirus, Parainfluenza types 1-4, four common coronaviruses (229E, OC43, NL63, HKU1), and SARS-CoV-2. The test is used to assess nasopharyngeal samples from patients showing signs of respiratory infection, in conjunction with clinical and epidemiological factors.
Roche’s Commitment to Respiratory Diagnostics
The launch of the cobas Respiratory flex test further strengthens Roche’s respiratory diagnostics portfolio, which also features the recently rebranded cobas® eplex system for multiplex and syndromic testing. This release follows Roche’s recent FDA Emergency Use Authorization for the cobas® liat test, which enables rapid detection of SARS-CoV-2, Influenza A/B, and RSV in emergency and near-patient settings. Roche continues to provide comprehensive diagnostic solutions for both large laboratories and smaller, point-of-care environments.
