FDA Approves MI Cancer Seek Test as a Groundbreaking Tool for Targeted Cancer Therapy

Caris Life Sciences announced that the U.S. Food and Drug Administration (FDA) has granted approval for the MI Cancer Seek™ test, the first diagnostic assay to simultaneously use Whole Exome and Whole Transcriptome Sequencing for targeted cancer therapies. Unique in its field, MI Cancer Seek is approved for both adult and pediatric patients (ages 1–22) and covers a broad spectrum of cancers, offering one pan-cancer and five tumor-specific indications for multiple FDA-approved treatments.

A Revolutionary Test Combining Two Sequencing Methods

MI Cancer Seek™ stands out as the first diagnostic tool to simultaneously use Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS), enabling a highly detailed molecular profile of solid tumors in patients. This dual approach, unprecedented in cancer diagnostics, enables a comprehensive evaluation of a tumor’s genetic mutations in a single test. It reduces the need for multiple tissue samples, speeding up diagnosis.

“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,” said Caris Chairman, Founder and CEO David Dean Halbert, DSc (h.c.). “We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools.”

The new diagnostic is aimed at identifying single nucleotide variants (SNVs), insertions, deletions (indels) across 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB), and copy number amplification (CNA) in breast cancer cases. With this breadth of molecular insight, MI Cancer Seek serves as a guide for oncologists to match patients with suitable targeted therapies based on their unique tumor biology.

MI Cancer Seek Companion Diagnostic Indications

Reducing the Burden on Patients

Traditionally, DNA and RNA analyses in cancer require separate tests, each demanding its own sample of tumor tissue. For many patients, particularly those with limited tumor tissue availability, this presents a barrier to timely and accurate diagnosis. By merging WES and WTS into one streamlined process, MI Cancer Seek reduces the need for multiple sample extractions without sacrificing accuracy, ensuring that the most comprehensive molecular data can be gathered quickly and efficiently.

Caris President David Spetzler emphasized the importance of FDA collaboration in bringing MI Cancer Seek to market. “The extensive rigor with which the FDA evaluates new technology ensures patients have access to safe and effective tests,” said  Spetzler, “The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies.”

About Author: Tracy Mokwe

With over 3 years of experience as a medical laboratory scientist and writer, I am passionate about translating complex scientific information into clear and accessible content. My expertise lies in medical sciences, laboratory science and research, digital health, AI, and cybersecurity in healthcare.