Related Experiment Video
Updated: Sep 11, 2025
MicroRNA Based Liquid Biopsy: The Experience of the Plasma miRNA Signature Classifier MSC for Lung Cancer Screening
Published on: October 26, 2017
Clinical and analytical validation of MI Cancer Seek®, a companion diagnostic whole exome and whole transcriptome
Valeriy Domenyuk1, Kasey Benson1, Peggy Carter1
1Caris Life Sciences, Irving, TX 75039, USA.
Abstract:
The precision oncology industry has evolved rapidly within the past two decades, although treatment selection remains a complex undertaking. Access to timely, accurate, and comprehensive molecular profiling data is imperative to improving patient outcomes within the expanding sphere of Food and Drug Administration (FDA)-approved targeted therapies. Caris Life Sciences has developed MI Cancer Seek®, an FDA-approved whole exome and whole transcriptome sequencing-based molecular test encompassing adult and pediatric tumor profiling, eight companion diagnostics (CDx), and additional laboratory developed test (LDT) capabilities. Patient tissue is maximized through simultaneous analysis of DNA and RNA with minimum input of 50 ng. The clinical and analytical validation presented herein demonstrates non-inferiority of MI Cancer Seek relative to other FDA-approved CDx tests (>97% negative and positive percent agreement), as well as its precision, sensitivity, and specificity. Accordingly, MI Cancer Seek represents a safe and effective comprehensive molecular test option supporting biomarker-directed care for oncology patients.
Insights
MI Cancer Seek is an FDA-approved molecular test providing comprehensive tumor profiling using whole exome and transcriptome sequencing. This test supports biomarker-directed care for oncology patients, enhancing treatment selection.
Area of Science:
- Oncology
- Genomics
- Molecular Diagnostics
Background:
- Precision oncology has advanced significantly, but treatment selection remains challenging.
- Access to comprehensive molecular profiling data is crucial for effective targeted therapies.
- The development of advanced diagnostic tools is essential for improving patient outcomes.
Purpose of the Study:
- To present the clinical and analytical validation of Caris Life Sciences' MI Cancer Seek molecular test.
- To demonstrate the test's comprehensive capabilities, including whole exome and transcriptome sequencing.
- To establish MI Cancer Seek as a reliable option for biomarker-directed cancer care.
Main Methods:
- Utilized whole exome and whole transcriptome sequencing for simultaneous DNA and RNA analysis.
- Employed a minimum of 50 ng of patient tissue for maximal sample utilization.
- Conducted clinical and analytical validation to assess performance against FDA-approved companion diagnostics.
Main Results:
- MI Cancer Seek demonstrated non-inferiority compared to other FDA-approved companion diagnostics, with >97% agreement.
- The test exhibited high precision, sensitivity, and specificity in molecular profiling.
- Validation confirmed the test's safety and effectiveness for oncology patients.
Conclusions:
- MI Cancer Seek is a validated, comprehensive molecular test for adult and pediatric oncology patients.
- The test supports biomarker-directed care by providing accurate and timely molecular profiling data.
- MI Cancer Seek offers a safe and effective option for improving treatment selection in precision oncology.
