SAGA Diagnostics Expands Ultrasensitive Pathlight MRD Test to Colorectal Cancer Following Strong CITCCA Study Results
Key Insights
SAGA Diagnostics (search) launched its ultrasensitive Pathlight (search) MRD test for colorectal cancer (search) patients, expanding beyond its initial breast cancer (search) application.
The CITCCA study of 377 stage I-III colorectal cancer (search) patients demonstrated that ctDNA (search)-positive patients had only 19% three-year relapse-free survival compared to 95% for ctDNA-negative patients.
Over 40% of high-risk patients had molecular residual disease (search) detectable only at ultrasensitive levels below 100 ppm, highlighting the clinical value of enhanced sensitivity.
SAGA Diagnostics (search) has launched its ultrasensitive Pathlight (search) MRD diagnostic test for colorectal cancer (search) patients, marking a significant expansion of the blood-based molecular residual disease (search) detection platform beyond its initial breast cancer (search) application. The commercial launch is supported by compelling data from the CITCCA study, one of the largest real-world ctDNA (search) studies conducted in stage I-III colorectal cancer.
Strong Clinical Evidence from CITCCA Study
The CITCCA (CIrculating Tumour DNA as a Prognostic and Predictive Marker in Colorectal CAncer (search)) study analyzed ctDNA (search) from 377 patients with stage I-III colorectal cancer across seven centers in Sweden between October 2020 and January 2024. The cohort included 232 colon cancer (search) patients and 145 rectal cancer (search) patients, with 25% of patients presenting with stage I disease.
The study demonstrated a striking association between post-treatment ctDNA (search) status and recurrence risk. Patients who tested ctDNA-positive following treatment experienced significantly higher rates of recurrence, with an overall hazard ratio of 38.5. The prognostic value was particularly pronounced in rectal cancer (search) patients, showing a hazard ratio of 93.5, compared to 33.8 for colon cancer (search) patients.
Ultrasensitive Detection Reveals Hidden Risk
The three-year relapse-free interval data revealed the clinical significance of ultrasensitive detection capabilities. ctDNA (search)-positive patients demonstrated a three-year relapse-free interval of approximately 19-30%, compared with 90-95% for ctDNA-negative patients. Critically, 42.5% of ctDNA-positive patients at the clinical landmark (4-6 weeks post-surgery) had molecular residual disease (search) detectable only at ultrasensitive levels below 100 parts per million.
"The striking difference in three-year recurrence-free interval between ctDNA (search)-positive and ctDNA-negative patients highlights the clinical value of structural-variant-based ultrasensitive MRD detection," said Professor Anna Martling, MD, from the Karolinska Institutet and principal investigator of the study. "Tools like Pathlight (search) have the potential to meaningfully improve how we risk-stratify patients and tailor treatment and follow-up strategies."
Treatment Decision Support
The study data also demonstrated the potential for ctDNA (search) testing to guide adjuvant therapy decisions. Recurrence risk was markedly higher in ctDNA-positive patients who did not receive adjuvant chemotherapy, suggesting that ctDNA status could inform treatment intensification strategies. In the study cohort, adjuvant therapy proved effective in improving survival outcomes for ctDNA-positive patients.
Addressing Critical Clinical Need
Colorectal cancer (search) represents the second leading cause of cancer-related death worldwide, with rising incidence rates. As treatment approaches become increasingly individualized, the need for sensitive tools to detect molecular residual disease (search) and guide therapeutic decisions has become more critical.
"Data from the CITCCA study reinforce the critical role of ctDNA (search) as a prognostic biomarker in early-stage colorectal cancer (search)," said Wendy Levin, MD, MS, Chief Clinical Officer at SAGA Diagnostics (search). "Importantly, more than 40% of ctDNA-positive patients had residual disease at levels only detectable with ultrasensitive methods, as enabled by Pathlight (search)'s structural-variant-based approach."
Commercial Expansion Strategy
The colorectal cancer (search) launch builds upon Pathlight (search)'s successful commercial introduction in early-stage breast cancer (search). Vicki Fish, Senior Vice President of Marketing & Sales at SAGA Diagnostics (search), emphasized the platform's potential: "Pathlight detects molecular residual disease (search) at extremely low levels – months ahead of clinical recurrence – opening new opportunities for earlier intervention."
The CITCCA study findings were presented at the 2026 American Society for Clinical Oncology Gastrointestinal Cancers Symposium, with data demonstrating the clinical utility of structural-variant-based ultrasensitive MRD detection in both colon and rectal cancer (search) populations.