The real-time PCR-based test runs on the BD Max system and comes in a single tube that snaps into the BD MAX extraction cartridge.
The PCR-based assays run on the company's Aries system, which itself received FDA clearance in October 2015.
The point-of-care test detects and distinguishes influenza A and B as well as respiratory syncytial virus in about 20 minutes.
The École Polytechnique Fédérale de Lausanne's Samira Asgari uncovered rare variants that seem to govern an extreme response to RSV or HRV infection.
The test is the first of several planned CLIA-waived assays from Cepheid, and the first point-of-care test on the market to differentiate flu from RSV.
The Enigma MiniLab runs single-tube multiplex panels at the point of care, with a lower price point than other commercially available syndromic panel platforms.
The assay runs on the company's fully automated PCR-based Idylla platform and detects various strains of the flu virus and respiratory syncytial virus.
With recent and impending launches of POC MDx platforms, some industry observers believe the technology could replace some POC immunoassays in a few years.
The firm has added 46 influenza strains and seven respiratory syncitial virus strains to its Simplexa Flu A/B & RSV Direct kit.
The waiver opens up a significant new opportunity for Alere within the physician office market, according to a company executive.
In PLOS this week: role for Notch signaling in congenital heart disease, sciatica risk variants, and more.
Researchers in China have used the CRISPR/Cas9 genome editing approach to alter the length of hair fibers in cashmere goats.
According to ScienceInsider, the Scripps Research Institute and the California Institute for Biomedical Research are merging.
National Cancer Institute researchers didn't report severe adverse events to Food and Drug Administration in a timely manner, the Wall Street Journal reports.