Redefining the early detection of molecular residual disease (MRD)
About Us
Our mission is to intercept cancer at the earliest stages when it’s most treatable.
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 also partners with biopharma companies, as well as commercial entities to support early through late-stage cancer development programs across a range of cancer types.
Our Science
Patient-specific and tumour-informed for more accurate detection and monitoring of MRD
SAGA’s Pathlight MRD platform utilizes whole-genome sequencing of a patient’s tumor specimen to identify candidate structural variants unique to the patient and the tumor. This information is used to generate a personalized, ultra-sensitive multiplex digital PCR (dPCR) assay or “fingerprint”, used to detect the presence or absence of circulating tumor DNA (ctDNA) in blood.
SAGA uses a proprietary algorithm to select SVs that are less susceptible to therapy selection and clonal evolution, and enables more accurate tracking of response to therapy.
Unlike single nucleotide variants (SNVs), which are commonly used by first-generation MRD technologies, SVs are often founding events in tumorigenesis and conserved throughout the course of disease progression, including metastasis, since they are more resistant to selective pressure during treatment.
The approach was clinically validated in a pivotal study published in Clinical Cancer Research¹, demonstrating unmatched sensitivity, specificity, and lead time for early-stage breast cancer (EBC) patients.
The Pathlight Difference
Pathlight™ is a blood-based, multi-cancer MRD platform that enables clinicians to monitor cancer progression from early detection through relapse and metastasis—supporting confident, informed treatment decisions at every stage of care.
With its first indication in breast cancer, Pathlight has been shown to deliver a 96% detection rate at baseline (pre-treatment) across all stages and subtypes, 94% in estrogen receptor-positive (ER+) breast cancer – a patient population in which first-generation MRD tests struggle to exceed 80%.
In a published study¹, Pathlight delivered 100% sensitivity, 100% specificity and a 13.7-month lead time, a powerful advantage for detecting recurrence early.
Pathlight breaks the 1ppm barrier and offers the potential to detect MRD at the earliest possible opportunity, to support individualized intervention directed towards cure.
100%
sensitivity
13.7
month lead time
100%
specificity
Latest News
The latest press releases and news updates from SAGA, including company updates, product launches, partnership announcements and clinical data.
Join #TeamSAGA
Join our accomplished team. SAGA combines world-class genomic expertise with a leadership team deeply experienced in molecular residual disease (MRD), all aligned around a compelling vision of intercepting cancer at the earliest stages when it’s most treatable.
References
1. Elliott MJ, Howarth K, Main S, et al. Ultrasensitive detection and monitoring of circulating tumor DNA using structural variants in early-stage breast cancer. Clin Cancer Res. Published online January 7, 2025. doi:10.1158/1078-0432.CCR-24-3472