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Caris Life Sciences study identifies 13,293 patients for new cancer therapies

May 15, 2026 8:32 AM

Caris Life Sciences (NASDAQ: CAI) published a study in The Oncologist demonstrating its Lookback Program's ability to identify previously-tested patients who become eligible for newly approved targeted cancer therapies.

The study analyzed 87 biomarker-directed FDA approvals between 2018 and 2025. From a database of more than 483,000 molecular profiles, the program identified 13,293 patients potentially eligible for newly approved targeted therapies across 10 tumor types.

The Caris Lookback Program, operational since 2014, continuously monitors new FDA approvals and guideline updates for biomarker-linked therapies. When new clinical actionability is identified, Caris reviews prior patient test results to identify those whose molecular profiles align with new recommendations without requiring additional testing.

"As the number of biomarker-driven therapies continues to accelerate, a static analysis limited to a single moment-in-time is no longer sufficient in many cases," said James Hamrick, MD, MPH, Chairman of the Caris Precision Oncology Alliance.

Approximately one-third of the 87 FDA approvals evaluated met criteria for inclusion in the program based on clinical value and actionability. The program's impact spanned solid tumors including non-small cell lung, breast, colorectal and pancreatic cancers, with non-small cell lung cancer accounting for approximately 40% of identified opportunities.

The study showed that biomarker detection required diverse methodologies, including Whole Exome Sequencing, Whole Transcriptome Sequencing, Immunohistochemistry and combinations of these approaches. When patients are identified as potentially eligible for new therapies, treating oncologists are notified through Medical Affairs and Molecular Science Liaison outreach.

MI Cancer Seek is described as the first simultaneous Whole Exome Sequencing and Whole Transcriptome Sequencing-based assay with FDA-approved companion diagnostic indications for molecular profiling of solid tumors, available for adult and pediatric patients ages 1 and older.

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