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 tool, called Cerebro, significantly outperformed other publicly available methods, including in the less-trafficked areas of the genome that are now relevant for TMB immunotherapy prediction.
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.
The results of the study could have implications for liquid biopsy developers that aim to pick out patients more likely to respond to immunotherapies.
Rady Children's Institute for Genomic Medicine and Deloitte are looking into the use of drones to transport samples for testing.
Direct-to-consumer genetic testing firm 23andMe is laying off about 100 people.
Researchers from Northwestern University examined dust for antibiotic-resistance genes, New Scientist reports.
In Science this week: researchers present a computational method for predicting cellular differentiation state from single-cell RNA sequencing data, and more.