SAGA Diagnostics Introduces MRD Colorectal Cancer Test

SAGA Diagnostics has launched of its ultrasensitive Pathlight early molecular residual disease (MRD) diagnostic test for colorectal cancer (CRC). This release expands Pathlight’s clinical application following its successful commercial debut last year for early-stage breast cancer.

Colorectal cancer is the second leading cause of cancer-related death worldwide, and its prevalence continues to grow.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, according to the company. Within the larger prospective study conducted in collaboration with investigators from the Karolinska Institutet, Pathlight was used to retrospectively analyze ctDNA from a 377-patient cohort, about 40% of whom were diagnosed with rectal cancer.

Pathlight demonstrated a strong and clinically meaningful association between post-treatment ctDNA status and recurrence risk, with ctDNA-positive patients demonstrating a 19% three-year relapse-free interval (RFI), compared with a 95% RFI 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 of Marketing and Sales at SAGA Diagnostics. “Pathlight detects molecular residual disease at extremely low levels—months ahead of clinical recurrence—opening new opportunities for earlier intervention. Bringing ultra-sensitivity and high prognostic value to colorectal cancer represents a major step forward in our mission to enable more precise, personalized care.”

SAGA Diagnostics is redefining the early detection of 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 U.S. commercial use 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 various cancer types. SAGA’s headquarters and CLIA-certified laboratory are located in the heart of the life science ecosystem in Research Triangle Park, N.C. SAGA Diagnostics combines genomic expertise with a leadership team experienced in MRD, all aligned to intercept cancer at its earliest stages when it is most treatable.

References
¹ https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer#
² https://pmc.ncbi.nlm.nih.gov/articles/PMC5395262/#