With recent and impending launches of POC MDx platforms, some industry observers believe the technology could replace some POC immunoassays in a few years.
A number of firms now have FDA-approved Group A Strep assays, but end users may be hesitant to adopt them until Infectious Disease Society of America guidelines are updated.
The test is the second to be waived for use on the Alere i isothermal nucleic acid amplification platform, and detects Group A Strep DNA in eight minutes or less.
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.
The University of California, Berkeley's Jennifer Doudna reflects at Science on the anniversary of the announcement of the birth of twin girls who underwent genome editing.
By studying its enamel proteome, researchers have found the ancient ape Gigantopithecus blacki belongs to a sister clade to that of orangutans.
Bloomberg Businessweek discusses genomics with BGI's Wang Jian.
In Science this week: researchers find transplanting the gut microbiome in mice affects physiology, and more.