Caris Life Sciences Launches Innovative Clinical Trial Solution to Increase Access for Underserved Cancer Patients

Expanding Access to Precision Oncology Trials

Caris Life Sciences®, Inc. (NASDAQ: CAI) is revolutionizing the way cancer clinical trials are conducted with its innovative Right-In-Time (RIT) clinical trial solution. This initiative seeks to address a pressing issue in the medical community: the significant geographic gap in access to cancer treatments, particularly for underserved populations. By bringing biomarker-driven clinical trials directly to community oncology practices, Caris ensures that a greater number of patients can participate in potentially life-saving research, overcoming previous barriers related to accessibility and infrastructure.

A revealing study published in JCO Oncology Practice highlights the stark reality that about 70% of counties across the United States do not offer active cancer treatment trials. This gap leaves a staggering portion of the population, especially those over 55, without a viable pathway to investigational therapies. Although nearly 85% of cancer patients receive care through community-based practices, most clinical trials remain confined to large academic medical institutions. The findings also suggest that the majority of patients who are offered clinical trial opportunities express a willingness to participate, but access remains a core issue.

Caris is tackling this critical challenge by implementing its RIT clinical trial solution in over 600 community oncology locations, staffed by 2,200 investigators across the United States and Puerto Rico. This initiative has already flagged over 71,000 patients as potential candidates for participation in various trials. The RIT solution promises to execute the process from molecular profiling to patient enrollment in as little as five days, significantly streamlining what has historically been a lengthy endeavor.

David Spetzler, President of Caris Life Sciences, emphasizes the importance of comprehensive molecular profiling in delivering effective treatment options. By intimately understanding each patient’s specific disease profile, oncologists can make better-informed decisions. The integration of this profiling with a clinical trial matching system vastly broadens the options available to patients, ensuring that no one is overlooked due to geographical constraints.

The urgency for aligning scientific advancements with clinical application is underscored by recent data revealing that a significant portion of eligible patients never access their approved therapies. A Caris-led investigation encompassing more than 295,000 real-world cancer patients illustrated that for a popular target, NTRK fusion genes, nearly half of eligible individuals remained untreated. The RIT solution directly addresses this disparity by providing oncologists with automatic access to historical trial data, helping bridge the gap between rare mutations and treatment opportunities.

At its core, the RIT program integrates vital steps, encompassing molecular profiling, automated trial matching, and efficient site activation. Each patient's tumor sample is subjected to advanced analyses, including Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS), and immunohistochemistry (IHC), covering an extensive range of over 23,000 genes. This data is then processed through a proprietary trial-matching platform that efficiently pairs patient profiles with suitable clinical trials from a robust portfolio of over 30 active trials.

Registered clinical trial navigators, equipped with oncology nursing expertise, play a pivotal role in this process. They oversee eligibility assessments and keep patients informed throughout the trial journey, ensuring seamless communication with treating physicians. This frees practitioners to focus on patient care without the additional burden of navigating trial logistics.

As of the end of 2025, Caris boasts one of the largest clinico-genomic databases in oncology, having processed over 1 million tumor profiles and established over 740,000 matched profiles that link molecular data to clinical outcomes. This extensive database supports a foundational role in developing the next generation of precision medicine, contributing to more than 1,050 peer-reviewed publications across its research partnerships, including associations with leading cancer centers.

Spetzler asserts, "Each patient diagnosed with cancer deserves a treatment plan that is personalized based on their unique molecular profile." The RIT initiative embodies Caris’s commitment to bridging the gap between cutting-edge research and practical application, ensuring geographic location does not dictate access to groundbreaking treatments. By embedding trial matching within the molecular profiling process, Caris paves the way for a future where comprehensive profiling becomes standard practice in oncology, ultimately enhancing patient outcomes across the board.

About Caris Life Sciences

Caris Life Sciences is at the forefront of the precision medicine landscape, committed to transforming healthcare through innovative solutions. By harnessing the power of comprehensive molecular profiling and advanced AI technologies, Caris remains dedicated to unraveling the complexities of disease and aligning therapeutic options with patient needs, truly embodying the potential of precision medicine.