The test, which detects various bacterial species in fecal samples, is expected to be submitted to US regulators before the end of this year.
The assays use specimens from symptomatic patients for the qualitative detection and differentiation of HSV-1 and HSV-2 with results generated within one hour.
The registry is expected to yield a "validated, semi-quantitative risk assessment algorithm that will assist physicians in managing patients at risk for ovarian cancer."
The decision proposes coverage for the test for qualified Medicare patients to help determine which early-stage patients can be more conservatively managed.
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.
In Nature this week: factors affecting the success of whole-genome sequencing for routine clinical diagnosis, and more.
A large meta-analysis from an international team reports that nature and nurture have about an equal overall influence on human traits.
The Lasker Foundation's Claire Pomeroy laments the state of NIH funding at Forbes.
Social media is changing how scientists discuss research, as tweets from University of Chicago's Yoav Gilad about a Mouse ENCODE paper have shown, Nature reports.