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AmoyDx aims to develop a companion diagnostic for Merck KGaA's non-small cell lung cancer treatment Tepmetko, which was recently approved in Japan.
Under the terms of the agreement Thermo Fisher will retain the rights to commercialize the companion test globally and seek regulatory approval.
The assay provides comprehensive genomic information to oncologists from a blood draw, using targeted next-generation sequencing of circulating cell-free DNA.
In a local coverage article, Medicare contractors in the MolDx program added prostate cancer to the covered indications for the test.
The company is employing Guardant360 in a Phase III trial assessing the efficacy of the drug both in a larger population and in women who test positive for ESR1 mutations.
The company recently said it was discontinuing development of its original and only in-house developed assay after a failed clinical validation.
Thermo Fisher has also applied to the Japanese Ministry of Health, Labor, and Welfare to expand the use of the Oncomine Dx Target test in Japan.
Burning Rock also said it will continue to develop companion diagnostics-related products based on next-generation sequencing technology.
The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
The DXRX marketplace, planned for launch in the fourth quarter of 2020, will provide a way for pharmaceutical companies, diagnostic firms, and laboratories to collaborate.
The startup is developing a qPCR-based profiling method that could provide results within hours to clinicians treating their cancer patients with immune checkpoint inhibitors.
The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The firms are developing a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2 and NTRK3, for Bayer's Vitrakvi cancer treatment.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
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.
23andMe has launched a new tool that estimates someone's risk of developing severe COVID-19 if infected, Bloomberg reports.
The Guardian reports that Pasteur Institute researchers are halting their development of a SARS-CoV-2 vaccine following disappointing initial results.
The Wall Street Journal reports that an increased number of younger patients have been hospitalized as the new SARS-CoV-2 strain spread across the UK.
In Cell this week: proteomic patterns among COVID-19 affected tissue samples, transcriptome atlas of developing intestines, and more.