Molecular profiling reports from most labs are static, reflecting clinical knowledge only at the time of testing. As new biomarker–drug associations and therapeutic indications emerge, patients with previously identified biomarkers may miss newly approved treatment opportunities, while clinicians face increasing challenges staying current with evolving evidence.

Since 2014, Caris patients have benefited from the dynamic Caris Lookback Program, which addresses limitations of static molecular profiling reports. Through this program, Caris continuously monitors new FDA approvals and guideline updates regarding biomarker‑linked therapies.  When new clinical actionability is identified, Caris retrospectively reviews prior patient test results to identify those patients whose molecular profiles align with the new or updated recommendations, all without the need for additional testing. Treating oncologists are then proactively notified through coordinated Medical Affairs and Molecular Science Liaison (MSL) outreach. Caris patients can therefore benefit long after testing has occurred and oncologists can benefit from updated therapeutic insights.

"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, Caris Precision Oncology Alliance. "The Caris Lookback Program was designed to extend the clinical value of comprehensive molecular profiling over time by continuously reviewing prior results through the lens of newly emerging therapeutic evidence, helping ensure that patients and their physicians can benefit from ongoing advances in precision oncology."

In this large real‑world analysis, Caris evaluated 87 biomarker‑directed FDA approvals between 2018 and 2025 using a structured clinical impact framework. Approximately one-third of these approvals met criteria for inclusion in the Caris Lookback Program based on their potential clinical value and actionability. 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 and multiple tumor‑agnostic indications.

The program's impact spanned a broad range of 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 also underscored the importance of multi‑modal profiling, as biomarker detection required diverse methodologies, including Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS), Immunohistochemistry (IHC) and combinations of these approaches.

Beyond molecular identification, the study also demonstrated the effectiveness of proactive clinical engagement. By integrating comprehensive molecular profiling with continuous evidence surveillance and targeted physician engagement, the Caris Lookback Program demonstrates how a single comprehensive test can deliver dynamic, longitudinal clinical utility, helping identify patients who may benefit from newly approved therapies without repeat biopsies or additional testing.

MI Cancer Seek® is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. MI Cancer Seek is available for adult and pediatric patients (ages 1+).