Solana leverages the helicase-dependent amplification technology that also underpins Quidel's AmpliVue molecular technology.
The Group B Strep test is the second test on the firm's menu granted clearance, and is intended for screening pregnant women.
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.
The company is focusing on hematological malignancies and looking to partner with pharmaceutical companies for companion diagnostics.
The trichomonas assay is Quidel's sixth assay running on the AmpliVue handheld molecular diagnostic device that has been cleared by the FDA.
Available in March, the PCR-based FilmArray 2.0 platform has higher throughput and takes up a smaller footprint.
The test uses the company's TOCE primer technology for multiplexed real-time PCR and is the first product Seegene has taken through the FDA.
The new clearance allows the use of the Xpert MTB/RIF test, in conjunction with other clinical or laboratory data, to remove patients from respiratory isolation.
The FDA conditionally approved the microarray-based gene expression test for use as entry criteria for a clinical trial for an investigational new drug for multiple myeloma.
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.