Caris Life Sciences announced that the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek for use as a companion diagnostic assay to identify patients with cancer who may benefit from targeted therapies. Caris Life Sciences is a next-generation artificial intelligence techbio company.
Overview of the Approval
MI Cancer Seek—a novel simultaneous whole-exome sequencing– and whole-transcriptome sequencing–based assay with FDA-approved companion diagnostic indications for molecular profiling of solid tumors—includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. The assay is available for use in both adults and pediatric patients over the age of 1.
The company explained that MI Cancer Seek is a next-generation sequencing–based in vitro diagnostic device using total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens for the detection of single nucleotide variants and insertions and deletions in 228 genes, microsatellite instability, tumor mutational burden in patients with previously diagnosed solid tumors, and copy number amplification in one gene in patients with breast cancer.
Typically, DNA and RNA analyses by next-generation sequencing necessitates two separate testing processes, which may require more tissue and time. However, by combining whole-exome sequencing and whole-transcriptome sequencing into one workflow, MI Cancer Seek may provide a comprehensive molecular blueprint that saves tissue without compromising results.
MI Cancer Seek is intended as a companion diagnostic assay to identify patients who may benefit from targeted therapies listed in the Companion Diagnostic Indications table—in accordance with the approved therapeutic product labeling. Additionally, the assay was designed to provide tumor mutational profiling to be used by qualified health-care professionals in accordance with professional oncology guidelines for patients with previously diagnosed solid malignancies. The company noted that 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.
Conclusions
“FDA approval of MI Cancer Seek … further demonstrates Caris [Life Sciences]’ continued leadership in molecular science and our extreme focus on quality,” detailed David Dean Halbert, DSc (hc), Chairman, founder, and Chief Executive Officer of Caris Life Sciences. “We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools,” he added.
“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,” emphasized 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,” he concluded.
For complete details on the companion diagnostic information and performance characteristics of MI Cancer Seek, visit carislifesciences.com.
