SAGA Diagnostics® Launches Ultrasensitive Pathlight™ MRD Test in Colorectal Cancer

CITCCA data demonstrate more than 40% of high-risk stage I–III colorectal patients harbor molecular residual disease at clinical landmark, detectable only with ultrasensitive ctDNA testing

MORRISVILLE, N.C.--(BUSINESS WIRE)--#CRC--SAGA Diagnostics, a pioneer in blood-based cancer detection and precision medicine redefining the standard for ultrasensitive and early molecular residual disease (MRD) detection, today announced the launch of its ultrasensitive Pathlight MRD diagnostic test for patients with colorectal cancer (CRC). This expands the clinical application of Pathlight following its successful commercial launch in early-stage breast cancer last year.

Colorectal cancer is the second leading cause of cancer-related death worldwide, and its incidence continues to rise^[1]. As CRC treatment becomes increasingly individualized, there is a critical need for sensitive tools to detect MRD and guide neoadjuvant and adjuvant therapy decisions^[2]. Circulating tumor DNA (ctDNA) has emerged as a powerful biomarker capable of identifying patients at high risk of relapse and supporting more precise clinical decision-making.

The launch is supported by data from the CITCCA study, one of the largest real-world ctDNA studies in stage I–III CRC, particularly in rectal cancer. Within the larger prospective study conducted in collaboration with investigators from the Karolinska Institutet, Pathlight was used to retrospectively analyze ctDNA from a cohort of 377 patients, of whom approximately 40% had rectal cancer.

Pathlight demonstrated a strong and clinically meaningful association between post-treatment ctDNA status and recurrence risk, with ctDNA-positive patients demonstrating a three-year relapse-free interval (RFI) of 19%, compared with an RFI of 95% for ctDNA-negative patients. Importantly, at landmark, 42.5% of ctDNA-positive patients had molecular residual disease detectable only at ultrasensitive levels (<100 ppm), highlighting the power of Pathlight’s structural-variant-based sensitivity. In this cohort, adjuvant therapy was effective in improving survival in ctDNA-positive patients. Collectively, these data support Pathlight’s ability to identify and stratify high-risk colon and rectal cancer patients who would be missed with less sensitive approaches.

“The colorectal data from CITCCA builds on the strong foundation Pathlight has established in breast cancer,” said Vicki Fish, Senior Vice President, Marketing & Sales. “Pathlight detects molecular residual disease at extremely low levels – months ahead of clinical recurrence – opening new opportunities for earlier intervention. Bringing ultrasensitivity and high prognostic value to colorectal cancer represents a major step forward in our mission to enable more precise, personalized care.”

About SAGA Diagnostics

SAGA Diagnostics^® is redefining the early detection of molecular residual disease (MRD), empowering treatment decisions with greater insight and confidence. Pathlight™, the company’s flagship product, is an ultra-sensitive, blood-based, multi-cancer MRD test that is now available for commercial use in the U.S. for patients with early-stage breast cancer. SAGA is partnering with pharmaceutical and biotechnology companies, as well as commercial entities, to support early through late-stage cancer development programs across a range of cancer types. SAGA’s headquarters and CLIA-certified laboratory are located in the heart of the life science ecosystem in Research Triangle Park, North Carolina. SAGA Diagnostics combines world-class genomic expertise with a leadership team deeply experienced in MRD, all aligned in the mission to intercept cancer at its earliest stages when it is most treatable.

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