MI Cancer Seek Receives FDA Approval as Companion Diagnostic for Targeted Therapy Across Tumor Types

Precision Medicine

The FDA has approved MI Cancer Seek as a companion diagnostic to identify adult and pediatric patients 1 to 22 years of age with cancer who may benefit from targeted therapy. MI Cancer Seek includes 1 pan tumor and 5 tumor-specific indications for several FDA-approved therapies.¹

The regulatory decision makes MI Cancer Seek the first and only simultaneous whole-exome sequencing (WES)– and whole-transcriptome sequencing (WTS)–based assay to earn FDA approval with FDA-approved companion diagnostic indications for the molecular profiling of solid tumors. By combining WES and WTS into a single workflow, MI Cancer Seek offers a comprehensive molecular blueprint that saves tissue without compromising results. Comparatively, DNA and RNA analysis by next-generation sequencing (NGS) usually requires 2 distinct testing processes, often necessitating more tissue and time.

“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,” David Dean Halbert, DSc (h.c.), chairman, founder, and CEO of Caris Life Sciences, stated in a news release. “We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools.”

MI Cancer Seek is a NGS-based in vitro diagnostic that utilizes total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens. The diagnostic uses this technology to detect single nucleotide variants, as well as insertions and deletions in 228 genes. MI Cancer Seek also can detect microsatellite instability (MSI) and tumor mutational burden in patients with previously diagnosed solid tumors, as well as copy number amplification in a single gene in patients with breast cancer.

MI Cancer Seek now holds companion diagnostic indications in breast cancer, colorectal cancer (CRC), melanoma non–small cell lung cancer (NSCLC), endometrial carcinoma, and solid tumors. In breast cancer, the diagnostic can detect PIK3CA alterations (C420R; E542K; E545A, E545D [1635G > T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y) for potential treatment with alpelisib (Piqray). In CRC, MI Cancer Seek can detect KRAS and NRAS wild-type biomarkers for potential treatment with panitumumab (Vectibix), as well as BRAF V600E for potential treatment with encorafenib (Braftovi) in combination with cetuximab (Erbitux).

In melanoma, MI Cancer Seek is indicated to detect BRAF V600E for potential treatment with FDA-approved BRAF inhibitors and BRAF V600E or V600K for treatment with trametinib (Mekinist) or FDA-approved BRAF/MEK inhibitor combinations. In NSCLC, the diagnostic can detect EGFR exon 19 deletions and exon 21 L858R alterations for potential treatment with FDA-approved EGFR TKIs. In endometrial carcinoma, MI Cancer Seek can identify patients who are not MSI high for treatment with pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima). Conversely, in solid tumors MI Cancer Seek can identify patient with MSI-high disease for treatment with pembrolizumab and/or dostarlimab-gxly (Jemperli).

“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,” David Spetzler, MS, PhD, MBA, president of Caris Life Sciences added in the news release.¹ “The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies.”

Reference

Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic (CDx) test. News release. Caris Life Sciences. November 6, 2024. Accessed November 6, 2024. https://www.carislifesciences.com/about/news-and-media/caris-life-sciences-receives-fda-approval-for-mi-cancer-seek/#:~:text=MI%20Cancer%20Seek%20is%20available,Halbert%2C%20DSc%20(h.c.)