Guardant told a federal judge that it believes Foundation Medicine and Personal Genome Diagnostics are coordinating to invalidate its patents.
PGDx, the defendant in the liquid biopsy IP case, has alleged that Guardant's CEO should have been named as an inventor on patents but was purposefully left off.
The in vitro diagnostic uses next-generation sequencing to detect clinically actionable genetic variants to guide therapy selection for cancer patients.
The firms will partner on studies needed to support and secure US regulatory approval for the Elio tissue complete assay.
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.
A New Zealand minister says the country's genetic modification laws need to be re-examined to help combat climate change, the New Zealand Herald reports.
A new analysis finds some cancers receive more nonprofit dollars than others.
An Australian mother's conviction in the deaths of her children may be re-examined after finding that two of the children carried a cardiac arrhythmia-linked gene variant.
In Science this week: comparative analysis of sex differences in mammal gene expression, and more.