On November 6, 2024 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies (Press release, Caris Life Sciences, NOV 6, 2024, View Source [SID1234647857]). The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. 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.

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"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."

MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) 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. Additionally, 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. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.

"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 Caris President David Spetzler, MS, PhD, MBA. "The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies."

MI Cancer Seek Companion Diagnostic Indications

Indication

Biomarker

Therapy

Breast Cancer

PIK3CA (C420R; E542K; E545A, E545D [1635G>T only],
E545G, E545K, Q546E, Q546R; and H1047L, H1047R,
H1047Y)

PIQRAY (alpelisib)

Colorectal Cancer
(CRC)

KRAS wild-type (absence of mutations in exons 2, 3, and
4) and NRAS wild type (absence of mutations in exons 2,
3, and 4)

VECTIBIX (panitumumab)

BRAF V600E

BRAFTOVI (encorafenib) in combination with ERBITUX
(cetuximab)

Melanoma

BRAF V600E

BRAF Inhibitors approved by FDA*

BRAF V600E or V600K

MEKINIST (trametinib) or BRAF/MEK Inhibitor
Combinations approved by FDA*

Non-Small Cell Lung
Cancer (NSCLC)

EGFR exon 19 deletions and exon 21 L858R alterations

EGFR Tyrosine Kinase Inhibitors approved by FDA*

Solid Tumors

MSI-H

KEYTRUDA (pembrolizumab), JEMPERLI (dostarlimab-gxly)

Endometrial
Carcinoma

Not MSI-H

KEYTRUDA (pembrolizumab) in combination with
LENVIMA (lenvatinib)

*For the most current information about the device indications for the therapeutic products in this group, go to: View Source

PIQRAY is a registered trademark of Novartis AG. VECTIBIX is a registered trademark of Immunex Corporation. BRAFTOVI is a registered trademark of Array BioPharma Inc. in the United States and various other countries. ERBITUX is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. MEKINIST is a registered trademark of Novartis AG Corporation Switzerland. KEYTRUDA is a registered trademark of Merck. LENVIMA (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

Typically, DNA and RNA analysis by NGS requires two separate testing processes, which may require more tissue and time. However, by combining WES and WTS into one workflow, MI Cancer Seek provides a comprehensive molecular blueprint that saves tissue without compromising results. For complete product details, including companion diagnostic information and performance characteristics, please visit www.CarisLifeSciences.com/MICancerSeek.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The agency is also responsible for the safety of the United States’ food supply, cosmetics, and radiation-emitting electronic products and for regulating tobacco products.