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PGDx and KingMed plan to provide tumor mutational burden testing to pharmaceutical companies for clinical trials in China and Hong Kong.
The trial will test two Bristol-Myers Squibb cancer drugs in patients with metastatic or unresectable tumors harboring mutations in the genes POLE and POLD1.
The funding will support efforts to convert PGDx's technology, including both tissue and liquid biopsy tests, for dissemination as regulated IVD kits.
The firm will work with the FDA to speed the approval process for its liquid biopsy assay, Elio, which analyzes SNVs, amplifications, rearrangements, and MSI.
The company is eyeing a launch for its IVD kits at the beginning of next year, as evidence grows for the integration of TMB analysis into the clinical care of cancer patients.
The ctDNA assay will be used to select patients for Phase 3 of Five Prime's registrational trial investigating bemarituzumab in gastric cancer patients.
PGDx has the exclusive rights to develop both tissue- and blood-based diagnostics using MSK’s TMB-related intellectual property.
The funds will support the commercialization of regulated genetic tests to identify molecular drivers of cancer and help individualize treatment strategies.
Advanced cancer patients at the VA will now have access to the company's blood-based PlasmaSelect 64 test as well as the CancerSelect 125 tissue test.
The belief among genomics experts that one day drugs would be given based on genomic abnormalities that cut across tumor types became reality this week.