Tumor sequencing tests may pick up age-associated mutations called clonal hematopoiesis, a noncancerous phenomenon that can have clinical implications.
The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.
The firm is in the midst of evaluating its strategic options and has hired Raymond James to assist in the process, which could include the sale of the firm, it said.
Farsight Genome Systems is touting the rapid scalability of its analytic pipeline as it seeks to make its technology "future-proof" for clinical genomics labs.
Chugai, a member of the Roche Group, has already filed for regulatory approval of FoundationOne CDx with Japan's Ministry of Health, Labor, and Welfare.
With multiple independent biomarkers, and potential combinations that may require even more subtyping, diagnostics to guide immunotherapy appears to be getting more complicated.
The agency said that its action on MSK IMPACT "advances a policy framework that paves the way for the efficient review and availability of other NGS-based cancer profiling tools."
The Irving, Texas-based company claims that three of Foundation Medicine's cancer molecular profiling tests infringe five of its US patents.
The collaboration will streamline patient sample analysis to determine whether they should be included in clinical trials for molecularly targeted treatment.