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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 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.
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.
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.
Researchers have identified immune cell gene expression signatures that could one day be developed into tests to predict response to treatment.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
The company said it plans to use the platform for research and development of companion diagnostics and in other oncology and precision medicine applications.
Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.
Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.
The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.
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