SAGA Diagnostics® Announces U.S. Commercial Launch of Pathlight™ at ASCO 2025, Setting a New Standard for Ultra-sensitive and Early MRD Detection
MORRISVILLE, N.C. – SAGA Diagnostics, a pioneer in blood-based cancer detection and precision medicine redefining the standard for ultra-sensitive and early molecular residual disease (MRD) detection, today announced the U.S. commercial launch of its Pathlight test for the detection of residual disease and recurrence at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, May 30 – June 3.
Pathlight’s baseline detection rate was 96% overall, and 94% in estrogen receptor-positive (ER+) breast cancer, which suggests clinical advantages over first generation ctDNA assays.
Pathlight is a first-of-its-kind, multi-cancer MRD platform, initially indicated for early breast cancer, that uses structural variants (SVs) as biomarkers. SVs are well-established hallmarks of cancer, arising from and contributing to genomic instability and oncogenesis. SVs, including breakpoints and rearrangements, are highly tumor- and patient-specific and often reflect the underlying tumor biology making them informative biomarkers for tracking disease.
Pathlight combines whole genome sequencing and proprietary algorithms and informatics optimized for the identification of stable SV breakpoints, generating a personalized genomic fingerprint for each tumor, which are subsequently orthogonally validated and tracked utilizing proprietary multiplex digital PCR to enable rapid, precise, efficient and quantitative MRD detection from a simple blood draw.
“By tracking structural variants — stable, unique, and tumor-defining fingerprints of each patient’s cancer — Pathlight enables interception of recurrence at its most treatable and potentially curable stage,” commented Roopom Banerjee, Executive Chairman of SAGA Diagnostics. “Our goal is to deliver the most accurate, trusted results that provide assurance and support confident, informed treatment decisions. Our published, peer reviewed data demonstrates the clinical validity of Pathlight in breast cancer and its potential power across all solid tumors and heme malignancies. SAGA has further partnered with leading clinicians, institutions, and biopharma to bring Pathlight to market and best serve patients.”
The clinical validity of Pathlight was established with samples collected in the TRACER (cTdna evaluation in eaRly breAst canCER) study, published in Clinical Cancer Research1 in January 2025. In this retrospective analysis of 100 patients with stage I–III breast cancer of all subtypes receiving standard-of-care neoadjuvant and adjuvant therapy Pathlight demonstrated best-in-class clinical performance – with 100% sensitivity and 100% specificity, and a 13.7-month lead time to recurrence as confirmed by clinical presentation or imaging. Notably, Pathlight’s baseline detection rate was 96% overall, and 94% in estrogen receptor-positive (ER+) breast cancer, which suggests clinical advantages over first generation ctDNA assays. Pathlight also delivered unparalleled sensitivity – breaking the 1ppm barrier and offers the potential to detect MRD at the earliest possible opportunity, to support individualized intervention directed towards cure.
“The vast majority of breast cancer patients are diagnosed with ER+ disease, and up to 25% will experience recurrence – often many years after completing curative-intent treatment,” said David Cescon, MD, PhD, medical oncologist and clinician scientist at Princess Margaret Cancer Centre, University Health Network and senior author of the paper. “We know that continued improvement in outcomes for people diagnosed with early breast cancer will require a shift towards more individualized treatment. There is a critical need for MRD testing that is both ultra-sensitive and ultra-specific, to enable long-term surveillance and risk-aligned treatment decisions for each patient.”
Pathlight has been submitted for US Reimbursement via the MolDX Program and is analytically validated across multiple cancer types. The test is already being used successfully in clinical studies by top pharmaceutical companies and at preeminent academic institutions and national cancer centers.
SAGA Diagnostics and its collaborators will be presenting three abstracts highlighting Pathlight’s performance in breast cancer, ovarian cancer and soft-tissue sarcoma at ASCO:
- Abstract #11511| June 1 | 9:00 a.m. – 12:00 p.m. CDT
Title: Potential of tumor-informed ctDNA as an early predictor for relapse in advanced ovarian cancer - Abstract #5574 | June 2 | 11:30 a.m. – 1:00 p.m. CDT
Title: Detecting ctDNA using personalized structural variants to forecast recurrence in localized soft tissue sarcoma (STS) - Abstract #3057 | June 2 | 1:30 p.m. – 4:30 p.m. CDT
Title: NeoCircle: Investigating circulating tumor DNA dynamics as a predictor of survival in primary breast cancer
SAGA will also be showcasing the capabilities and partnership opportunities of Pathlight at its booth (#36150) during the conference.
References
- 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. 2025;31(8):1520-1532. doi:10.1158/1078-0432.CCR-24-3472
About Pathlight
Pathlight™ is a next-generation, tumor-informed multi-cancer molecular residual disease (MRD) test, initially indicated for commercial testing in breast cancer. Pathlight uses whole genome sequencing to identify large-scale genomic changes, called structural variants (SVs), and tracks them over time using a unique combination of NGS and digital PCR, enabling industry-leading sensitivity and specificity. By optimizing for SVs that are stable, truncal biomarkers, Pathlight enables ultrasensitive recurrence detection and treatment response monitoring from early stage to metastatic disease. Developed and marketed by SAGA Diagnostics, the test has been submitted for US Reimbursement via the MolDX Program and is being used in clinical studies by multiple top 10 pharmaceutical companies and leading academic institutions and national cancer centers. For more information, www.pathlightMRD.com.
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 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 is 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 molecular residual disease (MRD), all aligned around a compelling mission of intercepting cancer at the earliest stages when it’s most treatable. For more information, www.sagadiagnostics.com.
