The story has been clarified to say the assay is available for patients ages 1 and above.
NEW YORK – Caris Life Sciences announced Wednesday that its MI Cancer Seek next-generation sequencing-based assay has received approval from the US Food and Drug Administration as a companion diagnostic for multiple therapies.
The test uses total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens to detect single nucleotide variants and insertions and deletions in 228 genes, as well as microsatellite instability, tumor mutational burden in patients with previously diagnosed solid tumors and copy number amplification in one gene in patients with breast cancer. The test combines whole-exome sequencing and whole-transcriptome sequencing into one simultaneous workflow.
The assay is intended as a companion diagnostic to identify patients who might benefit from treatment with targeted therapies, such as Novartis' Piqray (alpelisib) for breast cancer patients, Amgen's Vectibix (panitumumab), and Pfizer's Braftovi (encorafenib) in combination with Eli Lilly's Erbitux (cetuximab) for colorectal cancer patients, and Merck's Keytruda (pembrolizumab) and GlaxoSmithKline's Jemperli (dostarlimab-gxly) for patients with solid tumors. It is also intended for use with BRAF inhibitors approved by the FDA for melanoma and EGFR tyrosine kinase inhibitors approved by the FDA for non-small cell lung cancer, as well as Keytruda in combination with Eisai and Merck's Lenvima (lenvatinib) for endometrial carcinoma.
According to Caris, MI Cancer Seek is the first simultaneous whole-exome sequencing and whole-transcriptome sequencing-based assay for CDx indications approved by the FDA for molecular profiling of solid tumors. The test is available for patients ages 1 and above.