Press Release
CITCCA study data demonstrate strong association between ctDNA status and recurrence risk in stage I-III colorectal cancer
MORRISVILLE, NC — January 7, 2026 — SAGA Diagnostics, a pioneer in blood-based cancer detection and precision medicine redefining the standard for ultrasensitive and early molecular residual disease (MRD) detection, joins collaborators from the Karolinska Institutet to present new clinical data showcasing the ultrasensitive detection of ctDNA in colorectal cancer (CRC) using Pathlight at the 2026 American Society for Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, January 8-10 in San Francisco, CA.
The CIrculating Tumour DNA (ctDNA) as a Prognostic and Predictive Marker in Colorectal CAncer (CITCCA) study is one of the largest CRC ctDNA studies conducted to date, particularly in rectal cancer. Within the larger multicenter, prospective study, Pathlight retrospectively analyzed ctDNA from 377 patients with stage I–III colorectal cancer (25% of patients were stage 1), including 232 (~60%) patients with colon cancer and 145 (~40%) patients with rectal cancer, who received standard-of-care treatment and follow-up across seven centers in Sweden between October 2020 and January 2024. The primary objective was to evaluate the association between ctDNA status and recurrence-free interval (RFI), defined as the time from surgery to first radiological confirmation of recurrence.
Analysis of the data demonstrated:
“The CITCCA study provides compelling prospective evidence that ctDNA is a powerful predictor of recurrence in patients with stage I–III colorectal cancer,” said Professor Anna Martling, MD, Karolinska Institutet, Stockholm, Sweden and principal investigator of the study. “The striking difference in three-year recurrence-free interval between ctDNA-positive and ctDNA-negative patients highlights the clinical value of structural-variant-based ultrasensitive MRD detection. Tools like Pathlight have the potential to meaningfully improve how we risk-stratify patients and tailor treatment and follow-up strategies.”
Poster details:
“Data from the CITCCA study reinforce the critical role of ctDNA as a prognostic biomarker in early-stage colorectal cancer,” said Wendy Levin, MD, MS, Chief Clinical Officer, SAGA Diagnostics. “Importantly, more than 40% of ctDNA-positive patients had residual disease at levels only detectable with ultrasensitive methods, as enabled by Pathlight’s structural-variant-based approach. This finding underscores that test sensitivity matters – not just for identifying patients at highest risk of recurrence, but for informing more personalized decisions around adjuvant therapy and follow-up. We are proud to collaborate with the Karolinska Institutet on a study of this scale and quality, which advances the clinical evidence base for MRD-guided decision making for patients with colorectal cancer.”
The poster presented at ASCO GI will be available on SAGA’s website after the presentation.
Pathlight™ is a novel, personalized, tumor-informed multi-cancer molecular residual disease (MRD) platform developed by SAGA Diagnostics. It delivers industry-leading sensitivity and specificity for detecting cancer recurrence and monitoring treatment response by analyzing circulating tumor DNA (ctDNA).
Pathlight uses a proprietary combination of whole genome sequencing and digital PCR to identify and track large-scale genomic changes known as structural variants (SVs) – stable, truncal biomarkers that provide a clearer, earlier indication of disease recurrence. By optimizing for SVs, Pathlight enables ultra-sensitive detection of recurrence and precise monitoring of treatment response in early-stage and metastatic disease.
This advanced approach empowers oncologists to make timely, confident decisions—helping patients avoid unnecessary treatments or receive interventions sooner when needed. Pathlight supports accurate, longitudinal assessments of disease status, enhancing care across the entire patient journey.
Pathlight is covered by Medicare for early-stage breast cancer across all subtypes and is actively used in clinical studies by leading clinical institutions, national cancer centers and major pharmaceutical companies. For more information, visit www.pathlightMRD.com.
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 and reimbursed 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. For more information, visit sagadiagnostics.com.
