Makers of genetic health risk tests will only need one FDA review before commercializing tests, with some exceptions.
The DOJ alleged Biotheranosics promoted and performed its Breast Cancer Index test for patients who had not been in remission for five years and who had not been taking tamoxifen.
The firms are collaborating to develop a solution that includes Nightingale's nuclear magnetic resonance assay and PerkinElmer's sequencing services.
Private equity firm Quadria Capital led the investment round and was joined by HealthQuad Fund and Heritas Venture Fund.
Centogene opened a Boston office in December and plans to open a lab there in a few months as it awaits an FDA decision on its clinical tool.
Israeli bioinformatics startup KolGene eventually wants to offer an end-to-end tool that's integrated with EHRs and LIMS.
The investment bank said that an edit to CMS guidelines impacts payments for hereditary cancer testing, and could present Myriad with revenue and EPS headwinds.
The firm, which specializes in neurogenetics, recently launched several diagnostic RNA sequencing tests and is working on a methylome test for imprinting disorders.
Through the DNA Advantage Program, Cryobank will access Sema4's resources for reproductive health testing including DNA extraction and karyotype storage.
Despite years of experience of returning genetic test results, clinicians and researchers are still faced with many questions, such as what to do about VUS and secondary findings.