Caris Life Sciences has obtained an FDA approval for its MI Cancer Seek tumor profiling assay, unlocking its use as a companion diagnostic for multiple targeted medications across several cancers.
The company describes the precision medicine test as the first of its kind to offer simultaneous whole exome sequencing and whole transcriptome sequencing—with the ability to parse mutations in both DNA and RNA to identify patients that may benefit the most from specific therapies.
The MI Cancer Seek in vitro diagnostic examines genetic material isolated from standard tumor tissue specimens and queries 228 genes for single nucleotide variants as well as insertions and deletions. The next-generation sequencing test also determines the cancer cells’ microsatellite instability status and tumor mutational burden.
The FDA’s premarket approval green light spans one pan-cancer indication and five tumor-specific uses.
That includes pairings with Novartis’ Piqray (alpelisib) in breast cancers carrying a PIK3CA mutation; Amgen’s Vectibix (panitumumab) in wild-type KRAS and NRAS colorectal cancer; and a combination regimen for BRAF V600E-positive colorectal cancer with Pfizer’s Braftovi (encorafenib) and Eli Lilly’s Erbitux (cetuximab).
It also covers Novartis’ Mekinist (trametinib) in melanoma as well as other BRAF inhibitors and BRAF/MEK combination therapies approved by the FDA for the skin cancer. And, in non-small cell lung cancer with specific EGFR mutations, MI Cancer Seek can be used with approved tyrosine kinase inhibitors.
Finally, the assay can be used with Merck’s Keytruda (pembrolizumab) and GSK’s Jemperli (dostarlimab) across solid tumors with high microsatellite instability status as well as for Keytruda combined with Eisai and Merck’s Lenvima (lenvatinib) for endometrial carcinoma that does not have high microsatellite instability.
According to Caris, performing DNA and RNA analyses typically employs two separate testing processes, requiring more tissue and time. The company said its MI Cancer Seek test aims to save biopsy tissue with a single workflow.