Caris Lookback Program Flags 13,293 Patients for 87 New Targeted Therapies
CAI•Caris's Lookback Program retrospectively analyzed more than 483,000 molecular profiles to flag 13,293 patients now eligible for 87 new biomarker-directed FDA approvals across ten tumor types, with non-small cell lung cancer accounting for 40% of identified cases. MI Cancer Seek's combined WES/WTS assay extends clinical actionability without repeat biopsies.
1. Study Scope and Methodology
The Caris Lookback Program retrospectively reviewed 483,000 patient molecular profiles collected since 2014, evaluating 87 FDA biomarker-driven approvals issued between 2018 and 2025. Each potential biomarker–drug association was assessed through a structured clinical impact framework to determine eligibility for the program.
2. Key Findings and Patient Impact
Out of the profiles analyzed, 13,293 patients were identified as newly eligible for targeted therapies across ten tumor types. Non-small cell lung cancer alone accounted for approximately 40% of these identified treatment opportunities.
3. Continuous Surveillance and Clinical Outreach
The program continuously monitors FDA approvals and guideline updates, then retrospectively matches new indications to existing test results without requiring additional biopsies. Caris notifies treating oncologists through coordinated Medical Affairs and Molecular Science Liaison outreach, ensuring updated therapeutic insights reach clinicians.
4. Role of MI Cancer Seek Assay
MI Cancer Seek combines Whole Exome Sequencing and Whole Transcriptome Sequencing in a single FDA-approved CDx assay, enabling multi-modal biomarker detection. This dynamic approach extends the clinical utility of initial testing by integrating ongoing evidence surveillance with comprehensive molecular profiling.
