FDA approves Caris Life Science’s companion diagnostic for targeted cancer therapy

USA – The U.S. Food and Drug Administration (FDA) has approved Caris Life Sciences’ MI Cancer Seek, a new CDx assay as a companion diagnostic for identifying cancer patients who may benefit from targeted therapies.

Designed for both adult and pediatric patients aged 1 to 22, MI Cancer Seek is the first diagnostic of its kind to receive FDA approval for both whole-exome sequencing (WES) and whole-transcriptome sequencing (WTS) applications.

This regulatory decision marks a significant leap forward in precision medicine by enabling more efficient molecular profiling for solid tumors.

MI Cancer Seek combines two advanced technologies—WES and WTS—into a single, streamlined workflow.

By doing so, it offers a comprehensive molecular blueprint of tumors while conserving valuable tissue.

This is a significant improvement over traditional next-generation sequencing (NGS) methods, which typically require separate testing processes for DNA and RNA, consuming more tissue and time.

The diagnostic is capable of detecting genetic variants, including single nucleotide changes, insertions, deletions, and copy number alterations in a wide range of genes, making it a powerful tool for oncologists.

“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 David Dean Halbert, DSc (h.c.), chairman, founder, and CEO of Caris Life Sciences.

“We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools.”

Wide range of applications across cancer types

MI Cancer Seek can now be used for diagnosing and guiding treatment decisions in several types of cancers, including breast cancer, colorectal cancer (CRC), melanoma, non-small cell lung cancer (NSCLC), and endometrial carcinoma.

The diagnostic identifies specific genetic alterations that can inform the use of targeted therapies for each cancer type.

• Breast Cancer: MI Cancer Seek detects PIK3CA gene alterations, which may indicate suitability for treatment with alpelisib (Piqray).
• Colorectal Cancer (CRC): The diagnostic can detect KRAS and NRAS wild-type biomarkers, which help guide treatment with panitumumab (Vectibix), and BRAF V600E mutations, which can lead to treatment with encorafenib (Braftovi) in combination with cetuximab (Erbitux).
• Melanoma: The test can identify BRAF V600E or V600K mutations, potentially opening the door to treatments with BRAF inhibitors, including trametinib (Mekinist) or BRAF/MEK inhibitor combinations.
• NSCLC: MI Cancer Seek can identify EGFR exon 19 deletions and exon 21 L858R alterations, which guide treatment decisions involving FDA-approved EGFR tyrosine kinase inhibitors (TKIs).
• Endometrial Carcinoma: The diagnostic can identify patients for pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) based on their microsatellite instability (MSI) status.
• Solid Tumors: MI Cancer Seek can also detect MSI-high disease, guiding treatment with pembrolizumab and/or dostarlimab-gxly (Jemperli).

Advancing precision medicine

This approval reinforces Caris Life Sciences’ commitment to advancing precision medicine by offering clinicians a deeper, more accurate understanding of cancer at the molecular level.

By integrating WES and WTS into a single test, MI Cancer Seek offers an unprecedented level of detail in analyzing genetic alterations associated with tumor progression and therapy response.

This comprehensive approach enables oncologists to make better-informed decisions on personalized treatment plans.

“We are 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,” said David Spetzler, MS, PhD, MBA, president of Caris Life Sciences.

“The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies.”

The approval of MI Cancer Seek also highlights the growing role of companion diagnostics in the fight against cancer.

Companion diagnostics are essential for ensuring that patients receive the most effective treatments based on their genetic makeup.