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# Caris’ Companion Diagnostic for Cancer Approved
- URL: https://www.fdaweb.com/caris-companion-diagnostic-for-cancer-approved/
- Published: 2024-11-06T12:00:00.000Z
- Updated: 2026-09-14T14:46:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158132

FDA has approved Caris Life Sciences’ MI Cancer Seek and its use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. “The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies,” the company says. “MI Cancer Seek is the first and only simultaneous whole exome sequencing (WES) and whole transcriptome sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors,” it says.

The next-generation sequencing-based *in vitro* diagnostic device uses total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens to identify patients who may benefit from treatment with the following targeted therapies:

- Piqray (alpelisib) for breast cancer
- Vectibix (panitumumab) for colorectal cancer
- Braftovi (encorafenib) in combination with Erbitux (cetuximab) for colorectal cancer
- BRAF Inhibitors approved by FDA for melanoma
- Mekinist (trametinib) or BRAF/MEK inhibitor combinations approved by FDA for melanoma
- EGFR tyrosine kinase inhibitors approved by FDA for lung cancer
- Keytruda (pembrolizumab), Jemperli (dostarlimab-gxly) for solid tumors
- Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for endometrial carcinoma

Additionally, the company says MI Cancer Seek is intended to “provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.”