The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.
NSIGHT2 researchers surveyed the parents and doctors of sick babies to see how useful they found positive and negative findings from genome sequencing tests.
The firm said the New York State approval for the two tests comes soon after it launched Sema4 Signal, a family of precision oncology products and services.
ArcherDx will develop sequencing-based circulating tumor DNA assays for use in AstraZeneca's recently launched Phase III MERMAID-1 trial of durvalumab (Imfinzi).
Nearly 3,500 patients were referred to the Roberts Individualized Medical Genetics Center for exome sequencing or other testing during the clinical program's first four years.
The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.
Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
