Roche is rolling out what it describes as a new type of infectious disease diagnostic in Europe, with a single test capable of screening for up to 12 of the most common respiratory viruses at once.
Based on temperature-activated generation of signal technology, or TAGS, the company’s approach combines PCR testing with fluorescent color analysis and other sample data.
While a typical multiplex molecular diagnostic may check for four different genomic targets—say, the virus behind COVID-19 plus respiratory syncytial virus and two types of the flu—Roche says TAGS is capable of tracking as many as 15 pathogens with a single kit and can be run on existing instruments without hardware or software upgrades.
“Many respiratory illnesses share similar symptoms, making them difficult to diagnose,” Roche Diagnostics CEO Matt Sause said in a statement. “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.”
“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,” Sause added.
The CE marked diagnostic will first be made available in Europe for use on Roche’s cobas 5800, 6800 and 8800 analyzers. The company said it plans to submit the swab-based test for FDA review in the fourth quarter of this year.
The Respiratory flex test offers qualitative detection of influenza A and B, RSV, adenovirus, metapneumovirus, enterovirus and rhinovirus, parainfluenza 1, 2, 3 & 4, and four coronavirus strains.
The diagnostic also allows clinicians to specify which pathogens to look for, factoring in the test’s setting, season and locality, when certain communicable diseases may be more prevalent.
Roche said it plans to implement TAGS technology for high-throughput testing in multiple pathogens and indications.