Caris Life Sciences, an AI TechBio company, has received approval from the US Food and Drug Administration (FDA) for MI Cancer Seek as a companion diagnostic (CDx) to identify cancer patients who may benefit from targeted therapies.
The assay provides one pan-cancer indication and five tumour-specific indications for a range of FDA-approved therapies.
MI Cancer Seek is said to be the first and only assay to combine whole exome sequencing (WES) and whole transcriptome sequencing (WTS) with FDA-approved CDx indications for molecular profiling of solid tumours.
MI Cancer Seek is available for both adult and paediatric patients, aged one to 22 years.
Caris Life Sciences chairman, founder and CEO David Dean Halbert said: “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.
“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 that uses total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumour tissue specimens.
It is designed to detect single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, as well as microsatellite instability (MSI) and tumour mutational burden (TMB) in patients with previously diagnosed solid tumours.
Additionally, MI Cancer Seek can identify copy number amplification (CNA) in a specific gene for patients with breast cancer.
The assay serves as a companion diagnostic, identifying patients who may benefit from targeted therapies listed in the Companion Diagnostic Indications table, in line with the approved therapeutic product labelling.
Furthermore, MI Cancer Seek provides tumour mutational profiling, intended for use by qualified healthcare professionals in accordance with oncology guidelines for patients with previously diagnosed solid malignant neoplasms.
Caris Life Sciences president David Spetzler said: “We are very excited to receive FDA approval for our MI Cancer Seek test. The extensive rigour with which the FDA evaluates new technology ensures patients have access to safe and effective tests.
“The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies.”
