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The nonexclusive deal includes Personal Genome Diagnostics' US Food and Drug Administration-cleared Elio Tissue Complete cancer genomic profiling assay.
News items for the in vitro diagnostics industry for the week of Sept. 7, 2020.
The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.
The partners will focus on optimizing technology and conducting clinical utility studies for liquid biopsy and tissue-based genomic applications.
A federal court said Guardant CEO Helmy Eltoukhy deleted emails pertaining to two similar cases, but it remains unclear whether he did so intentionally.
The company is using the test to direct patient enrollment and treatment stratification in a trial of pembrolizumab (Keytruda) combination treatments.
The in vitro diagnostic uses next-generation sequencing to detect clinically actionable genetic variants to guide therapy selection for cancer patients.
The company said it has seen progress in efforts to get FDA approval for its tissue and liquid biopsy tests as data continues to accumulate for pan-cancer utility.
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.