Solana leverages the helicase-dependent amplification technology that also underpins Quidel's AmpliVue molecular technology.
The firm received CLIA waiver of a strep A assay on its Liat platform yesterday, and a favorable evaluation of its influenza A/B assay was published last week.
The point-of-care Roche cobas Liat Strep A assay can now be run in physician's offices and pharmacy clinics.
The agency also categorized the test as moderate complexity, which will allow some clinicians to perform the test directly.
The test is the second assay on the Alere i molecular platform, which was previously CLIA waived to run a flu test.
Infection with Fusobacterium necrophorum resembles strep throat, and may be as prevalent in young adult populations.
HiberGene hopes to launch its assays, based on loop-mediated isothermal amplification, in the EU in the third quarter of this year.
The waiver opens up a significant new opportunity for Alere within the physician office market, according to a company executive.
NEW YORK (GenomeWeb) — The US Food and Drug Administration has cleared for marketing Quidel's AmpliVue GAS Assay for detection of Group A Streptococcus from throat swabs in patients with symptoms of pharyngitis, the company announced today.
The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.
Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.
Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.
In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.