Caris Life Sciences publishes study validating MI Cancer Seek analytical and clinical performance.

Friday, Aug 15, 2025 9:01 am ET1min read

Caris Life Sciences has published a study validating the performance of MI Cancer Seek, a FDA-approved companion diagnostic that identifies cancer patients who may benefit from targeted therapies. The study shows that MI Cancer Seek works reliably for detecting clinically significant variants and follows strict laboratory standards. The test combines whole exome and transcriptome sequencing with FDA-approved indications for solid tumor profiling in adult and pediatric patients.

Caris Life Sciences has published a study in Oncotarget validating the performance of its FDA-approved MI Cancer Seek companion diagnostic (CDx) assay. The study demonstrates that MI Cancer Seek reliably detects clinically significant variants and adheres to strict laboratory standards. The test combines whole exome and transcriptome sequencing for solid tumor profiling in both adult and pediatric patients, marking a significant advancement in precision oncology.

The MI Cancer Seek assay received FDA approval and is the first and only solution to combine whole exome sequencing (WES) and whole transcriptome sequencing (WTS) for solid tumor profiling in both adult and pediatric patients. The study highlights that MI Cancer Seek offers exceptional accuracy, with positive and negative percent agreement ranging from 97% to 100% compared to other FDA-approved assays. This high level of performance is crucial for identifying patients who may benefit from targeted therapies.

One of the key differentiators of MI Cancer Seek is its ability to perform simultaneous RNA and DNA extraction from minimal tissue input, streamlining the testing process and potentially reducing delays in treatment decisions. This feature is particularly valuable as it allows for comprehensive molecular profiling without the need for additional tissue samples, thus conserving precious tumor material.

The study underscores Caris Life Sciences' commitment to scientific integrity and validation. The MI Cancer Seek assay supports eight companion diagnostic claims, each addressing high clinical burden areas and demonstrating strong performance. This comprehensive approach positions Caris strongly in the precision medicine market.

For oncologists, the validation of MI Cancer Seek provides confidence in using a single comprehensive test rather than ordering multiple separate assays. This can reduce diagnostic time and preserve tumor samples, aligning with the growing clinical need for tissue conservation while maximizing molecular information to guide targeted therapy selection.

Caris Life Sciences' MI Cancer Seek represents a significant advancement in precision oncology, offering a reliable and efficient solution for identifying patients who may benefit from targeted therapies. The study's findings further cement the company's position as a leader in the precision medicine market.

References:
[1] https://www.stocktitan.net/news/CAI/caris-life-sciences-demonstrates-scientific-rigor-with-clinical-la7ia3cs6wsv.html
[2] https://www.prnewswire.com/news-releases/caris-life-sciences-demonstrates-scientific-rigor-with-clinical-validation-of-fda-approved-mi-cancer-seek-302530610.html

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