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The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.
The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.
Under the deal, the companies aim to develop a companion diagnostic for Bayer's solid tumor drug larotrectinib for the Chinese market.
The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.
The company's PD-L1 IHC 22C3 pharmDx identifies patients with non-small cell lung cancer who qualify for first-line monotherapy with pembrolizumab.
The firm said as part of a development study it is using a gut microbiome analysis tool developed in collaboration with Thermo Fisher Scientific.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
The FDA approved the drug based on data on response rate but continued approval is contingent on the results of a randomized study showing a PFS and OS advantage.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
The agency recognized that having some companion tests approved for a few but not all cancer drugs with the same molecularly defined indication is not optimal for patient care.
Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.
The drug, tepotinib, will now be available to treat advanced non-small cell lung cancer patients in Japan with MET exon 14 skipping alterations.
The companies will work together to develop a next-generation sequencing-based companion diagnostic for an undisclosed cancer therapy.
The companies initially plan to validate biomarkers for use with the Oncomine Dx Target Test to identify NSCLC patients for enrollment into clinical trials.
InfanDx is taking the lead on the project and will be joined by researchers from University Hospital Essen, Clinic for Pediatrics I, and Furtwangen University.
The company has overcome one major hurdle and is poised to clear another in the first half of this year, clearing the way for new test development.
Genetron will provide clinical trial genomic testing and companion diagnostic development services for InnoCare's biomarker-driven oncology drug development.
ARUP partnered with BioMarin to develop the blood-based assay, which is intended to identify those patients most likely to respond to the drug firm's AAV5-based gene therapy.
Qiagen's Q4 revenues of $413.5 million represented 4 percent growth at constant exchange rates and bested Wall Street's expectation of $405.6 million.
Myriad filed an sPMA for myChoice CDx despite GSK's confidence that Zejula will be approved in newly diagnosed ovarian cancer regardless of biomarker status.