The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.
Guardant told a federal judge that it believes Foundation Medicine and Personal Genome Diagnostics are coordinating to invalidate its patents.
The Patent Trial and Appeal Board has denied Foundation Medicine's request for Inter Partes review.
The companies will work together first to develop a companion diagnostic for Bayer's TRK inhibitor larotrectinib, with opportunities to expand to other drugs and drug candidates thereafter.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
The contract covers all of Foundation Medicine's genomic profiling tests, including FoundationOne CDx, FoundationOne Liquid, and FoundationOne Heme.
CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.
MSK researchers showed that high TMB may be associated with improved survival across tumor types, but the cut-offs for high and low status will vary based on histology.
The issue, discovered in late October, affected TMB reporting for up to 800 FoundationOne CDx tests during a short period of time and was quickly resolved.