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 company is commercializing a genome-wide sequencing method called MRDetect, developed by researchers at the New York Genome Center and Weill Cornell Medicine.
The framework is meant to guide healthcare providers in facilitating prostate cancer genetic testing in a timely and responsible way, the researchers said.
Thermo will develop a test using its Oncomine Precision Assay to identify IDH1- and IDH2-positive low-grade glioma patients for treatment with Agios' vorasidenib.
The New York-based firm will use the funding to develop and clinically validate its personalized, real-time tool for monitoring recurrence and treatment response for various sold cancer types.
Promega will seek to expand use of the assay in Europe while it works through regulatory review of the test for companion diagnostic use in the US and Asia.
ArcherDx has leveraged next-generation sequencing to develop and commercialize more than 325 research-use-only products and a pan-solid tumor diagnostic test.
The Swedish company said it will use the funds in part to accelerate the commercialization of its PanCan-d test for early-stage pancreatic cancer detection.
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.
