Caris will sequence DNA and RNA for certain cancer patients and potentially help Merus enroll cancer patients with NRG1 fusions in the Phase I/II eNRGy trial for zenocutuzumab.
The tool, which has been validated in two independent patient cohorts, uses artificial intelligence to predict patients likely to benefit from upfront FOLFOX.
The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
