The U.S. Food and Drug Administration (FDA) has approved Caris Life Sciences' MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from targeted treatments.
MI Cancer Seek is a simultaneous whole exome sequencing- and whole transcriptome sequencing-based assay that includes one pan-cancer and five tumor-specific indications for several FDA-approved therapies; it is available for use in patients from the ages of 1 to 22.
In a statement, Caris noted that it is the first and only available therapeutic with FDA-approved CDx indications for the molecular profiling of solid tumors.
MI Cancer Seek is a next-generation sequencing-based IVD device that uses total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens for the detection of single nucleotide variants and insertions and deletions in 228 genes, microsatellite instability, tumor mutational burden in patients with previously diagnosed solid tumors, and copy number amplification in one gene in patients with breast cancer.
Among the treatments indicated for use with it as a CDx are Piqray (alpelisib) for breast cancer, Vectibix (panitumumab) and Braftovi (encorafenib) in combination with Erbitux (cetuximab) for colorectal cancer, BRAF inhibitors and Mekinist (trametinib) or BRAF/MEK inhibitor combinations for melanoma, epidermal growth factor receptor tyrosine kinase inhibitors for non-small cell lung cancer, Keytruda (pembrolizumab) and Jemperli (dostarlimab-gxly) for solid tumors, and Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for endometrial carcinoma.
