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Roche Launches 12-Virus Diagnostic Test Across Europe

NextEdge Admin

25 Sep 2024

2 min 21 sec

Roche is introducing a new infectious disease diagnostic in Europe capable of screening for up to 12 common respiratory viruses in a single test. The test uses temperature-activated generation of signal (TAGS) technology, combining PCR testing with fluorescent color analysis and other sample data.

While conventional multiplex molecular diagnostics typically detect up to four genomic targets—such as COVID-19, respiratory syncytial virus (RSV), and influenza—Roche’s TAGS-based test can track up to 15 pathogens in a single kit. Importantly, it can be used on existing cobas instruments without requiring hardware or software upgrades.

“Many respiratory illnesses have similar symptoms, making diagnosis difficult,” said Roche Diagnostics CEO Matt Sause. “With increasing respiratory outbreaks and antibiotic resistance, accurate and timely diagnoses are critical for effective patient care and reducing transmission.”

The cobas Respiratory flex test, powered by TAGS technology, helps clinicians quickly identify specific respiratory viruses, enabling faster diagnoses and treatment. Initially, the CE-marked test will be available in Europe for use on Roche’s cobas 5800, 6800, and 8800 analyzers. Roche plans to submit it for FDA approval in the fourth quarter of this year.

The test detects influenza A and B, RSV, adenovirus, metapneumovirus, enterovirus, rhinovirus, parainfluenza 1, 2, 3, and 4, and four coronavirus strains. Clinicians can also tailor the test to specific pathogens based on location, season, and prevalent communicable diseases. Roche aims to apply TAGS technology to high-throughput testing for multiple pathogens in various indications.