Caris Life Sciences, an Irving-based next-generation AI TechBio company and precision medicine pioneer, announced that the U.S. Food and Drug Administration has approved MI Cancer Seek for use as a companion diagnostic to identify cancer patients who may benefit from treatment with targeted therapies.

“FDA approval of MI Cancer Seek — the first of its kind — further demonstrates Caris’ continued leadership in molecular science and our extreme focus on quality,” Caris Founder, Chairman, and CEO David Dean Halbert said in a statement. “We’re thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools.”

Caris said the assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies.

The company said that 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.

MI Cancer Seek is available for adults and pediatric patients, ages 1-22, Caris said.

How it works and what it does

The company said that MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions in 228 genes, microsatellite instability, and tumor mutational burden in patients with previously diagnosed solid tumors, and copy number amplification in one gene in patients with breast cancer.

MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table, in accordance with the approved therapeutic product labeling, Caris said. Also, 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.

“We’re very excited to receive FDA approval for our MI Cancer Seek test. The extensive rigor with which the FDA evaluates new technology ensures patients have access to safe and effective tests,” Caris President David Spetzler said in a statement. “The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies.”

Typically, DNA and RNA analysis by NGS requires two separate testing processes that may require more tissue and time.

By combining WES and WTS into one workflow, MI Cancer Seek provides a comprehensive molecular blueprint that saves tissue without compromising results.

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