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The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
Thermo Fisher said the assay is the first and, so far, only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
Amoy will develop its AmoyDx Pan Lung Cancer PCR Panel (9-in-1 Plus) as a companion diagnostic test for Haihe's MET kinase inhibitor Glumetinib.
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.
The test detects the HER2 biomarker in breast cancer and can be completed within the same day, allowing for faster results than other HER2 testing methods.
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 firm expects to launch a tissue-based immunohistochemistry version of the test, which detects QSOX1, in mid-2021, followed by a dipstick plasma-based assay by early 2022.
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.