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.
HiberGene hopes to launch its assays, based on loop-mediated isothermal amplification, in the EU in the third quarter of this year.
The Wall Street Journal looks into FamilyTreeDNA's handling of genetic genealogy searches by law enforcement.
In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.
MIT's Technology Review reports that researchers hope to develop a CRISPR-based pain therapy.
In Science this week: atlas of malaria parasites' gene expression across their life cycles, and more.