Caris Life Sciences has recently conducted a study, published in Oncotarget, to validate the analytical and clinical performance of MI Cancer Seek, an FDA-approved assay designed as a companion diagnostic (CDx) for identifying cancer patients who could benefit from targeted therapies. This innovative test integrates whole exome sequencing (WES) and whole transcriptome sequencing (WTS) to provide CDx indications for solid tumor profiling in both adult and pediatric patients. The study confirms that MI Cancer Seek is effective in detecting multiple variant types of high clinical significance, adheres to stringent laboratory standards, and supports eight CDx claims with a strong performance compared to other FDA-approved assays, boasting positive and negative percent agreement ranging from 97% to 100%.
George W. Sledge, Jr., MD, Caris EVP and chief medical officer, emphasized the importance of broad-based biomarker panels in enhancing precision medicine outcomes. By incorporating companion diagnostic tests into multi-gene panels that optimize tissue samples, inefficiencies can be reduced, potentially enabling more patients to access personalized therapies. MI Cancer Seek, utilizing next-generation sequencing (NGS) on total nucleic acid (TNA) from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens, detects single nucleotide variants (SNVs), insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB), and copy number amplification (CNA) in breast cancer patients. The assay is intended to guide treatment decisions with targeted therapies based on the patient’s genetic profile.
David Spetzler, MS, PhD, MBA, president of Caris, highlighted that MI Cancer Seek offers a comprehensive molecular blueprint while conserving tissue, a crucial factor in cancer diagnosis and treatment planning. The study results affirm the company’s dedication to scientific integrity and validation, ensuring that patients and physicians can rely on the test for informed decision-making in cancer care. Caris Life Sciences, as a pioneer in precision medicine and next-generation AI TechBio solutions, is committed to advancing healthcare through innovative technologies and personalized medicine approaches.
In conclusion, Caris Life Sciences’ validation of MI Cancer Seek underscores the importance of scientific rigor and validation in precision oncology. By providing a reliable and comprehensive molecular profiling assay, Caris aims to empower healthcare professionals and patients with valuable insights to guide personalized treatment decisions. The successful validation of MI Cancer Seek represents a significant advancement in precision medicine, offering a promising tool for identifying patients who may benefit from targeted therapies based on their tumor’s genetic characteristics.
- MI Cancer Seek combines WES and WTS for solid tumor profiling
- The assay supports eight CDx claims with high clinical performance
- Broad-based biomarker panels enhance precision medicine outcomes
- MI Cancer Seek conserves tissue while providing a comprehensive molecular blueprint
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