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.
The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.
The company announced this week the expansion of a genetic testing program for US patients with inherited retinal disease that it has run with partners since 2017.
The companies will use Foundation Medicine's FoundationOne CDx test as the baseline to define a set of unique variants that the codeveloped assays will monitor.
