CMS has attempted to address stakeholders' concerns about its coverage criteria for germline NGS testing in a new proposed national policy.
According to Natera CEO Steve Chapman, the agreement will not detract from Natera's own efforts to establish its exome sequencing-based Signatera assay.
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.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
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.