A personalized test powered by unparalleled knowledge of each tumor’s source code

Pathlight leverages patient- and tumor-specific structural variants (SVs) and proprietary dPCR technology to generate a molecular fingerprint, enabling superior sensitivity and specificity.

Meeting the need for reliable monitoring

Breast cancer is the most common malignancy among women worldwide and the second leading cause of cancer death in U.S. women2.

In the U.S. alone, approximately 300,000 women are expected to be diagnosed with breast cancer in 20253, with roughly 90% presenting at early stages (I–III)4, and 50% presenting in stages I-IIA5.

Approximately 70–75% of all breast cancers are estrogen receptor-positive (ER+), making it the most prevalent biologic subtype5.

ER+ breast cancer can have a highly variable risk prognosis6 — with nearly 40% characterized as high-risk Luminal B or Basal-like subtypes7 — which requires long-term monitoring.

Clinicians need a reliable way to detect early molecular recurrence for monitoring neoadjuvant treatment; to perform risk stratification to guide decisions about adjuvant or extended endocrine therapy; and to assess evidence of residual disease post-surgery—providing patients with reassurance or guiding effective intervention.

The Pathlight Difference

Pathlight’s proprietary algorithm optimizes for stable, truncal biomarkers, enabling improved tracking of a patient’s response to therapy.

Instead of single nucleotide variants (SNVs), which are more susceptible to therapy selection pressure, Pathlight utilizes whole-genome sequencing of a patient’s tumor specimen to identify larger structural variants (SVs) that are reliably detected, enabling 100% clinical specificity and sensitivity.

Setting a new standard for MRD sensitivity and specificity

Pathlight overcomes one of the toughest challenges in oncology – sensitive, specific, and earlier detection of molecular residual disease (MRD) and recurrence – increasing the chances for successful treatment.

Unparalleled specificity

SVs are stable and unique to each patient and tumor, enhancing the specificity of MRD testing and reducing false positives.

Ultra-sensitive detection

SVs often occur early in tumorigenesis and are often amplified in the tumor, resulting in more ctDNA fragments, enabling sub 1ppm detection, 100% analytical specificity, and longer lead times.

No sensitivity cliff

NGS-based technologies have background error rates that determine what is called “positive.” Due to whole genome SV biology and SAGA’s proprietary technology platforms, Pathlight has no such threshold, meaning a positive result can be reported based on the detection of a single ctDNA molecule.

MRD testing for every stage

Whether for early-stage recurrence detection, late-stage metastatic monitoring, or tracking therapeutic response, Pathlight provides insights, empowering clinicians to make informed treatment decisions.

Robust workflow

Pathlight results in a pass rate for plasma samples of >99.9% in published work by Elliott, Cescon and colleagues1, and produces a successful fingerprint for ctDNA analysis in 94% of patients.

A trusted partner selected by pharma for clinical studies

Pathlight is being used in clinical studies by multiple top 10 pharmaceutical companies and leading academic institutions and national cancer centers.

Billing and patient support
for Pathlight

At SAGA Diagnostics®, we understand that in a world of uncertainty following a cancer diagnosis, navigating your cancer care is challenging — emotionally, medically and financially. That’s why we are fully committed to making access to our advanced MRD technology as easy and transparent as possible.

Understanding your coverage

Pathlight is a personalized next-generation tumor-informed liquid biopsy assay designed to detect and monitor molecular residual disease (MRD) in patients diagnosed with solid tumors. Pathlight delivers trusted insights that help empower patients and clinicians to personalize treatment options. Coverage for Pathlight may vary depending on your insurance plan and specific policy terms.

Our client services team is here to support you at every step — from verifying coverage to providing clear explanations about your benefits and out-of-pocket costs.

Frequently Asked Questions

(FAQs)

What is the Patient Support Program?

We believe financial constraints should never be a barrier to the care you need.

Our Pathlight Patient Support Program is designed to support uninsured and underinsured financially eligible patients.

Support May Include:

  • Full or partial financial assistance based on household income and financial hardship
  • Help with insurance appeals for denied claims
  • Interest-free payment plans for eligible balances

How to Apply:

  • Call our Billing Team line at 1-919-371-0283 or 1-866-226-2611 or email us at billing@sagadiagnostics.com to request an application.
  • Complete the brief form, including household income details and supporting documentation (if applicable).

Submit the application via email or mail. A member of our support team will review and respond to your application and contact you within 5–7 business days.

If you have questions – We are here to help.

Our dedicated billing specialists are available to provide assistance with insurance questions, payment options, and financial aid.

Billing Support: 1-919-371-0283

Toll Free: 1-866-226-2611

Email: billing@sagadiagnostics.com

Monday – Friday, 9 AM – 5 PM EST

We know financial concerns can create real stress during treatment. That’s why our goal is simple — to ensure cost is never the reason someone misses out on personalized, potentially life-saving care.

How much does the Pathlight test cost?

The total cost of the Pathlight test can vary depending on your insurance coverage, and any applicable copays or deductibles. We will work with your healthcare provider and insurance plan to determine your expected out-of-pocket cost before the test is performed. If you’re uninsured or underinsured, you may qualify for our Patient Support Program.

What if my insurance denies coverage?

If your insurance denies coverage, don’t worry — our billing team will walk you through next steps and support you in submitting an appeal. You’re not alone.

You may also apply for financial support through our Patient Support Program if you face financial hardship.

How do I apply for the Patient Support Program?

Call our Client Services line at 1-919-371-0283 or email us at billing@sagadiagnostics.com to request an application.

Complete the brief form, including household income details and supporting documentation (if applicable).

Submit the application via email to billing@sagadiagnostics.com.

A member of our support team will review and respond to your application and contact you within 5–7 business days.

Can I set up a payment plan?

Please contact our billing support team to discuss flexible options.

Will I receive a bill before the test is performed?

No. We begin the insurance verification process once your test is ordered. If any out-of-pocket costs are anticipated, you will be notified before billing. We will not send a bill without first communicating your coverage details and financial responsibility.

Who can I contact if I have more questions about my bill?

Billing Support: 1-919-371-0283

Toll Free: 1-866-226-2611

Email: billing@sagadiagnostics.com

Monday – Friday, 9 AM – 5 PM EST

Redefining the standard 
for MRD detection

Pathlight is driving a new era of oncology patient care.

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
  2. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. doi:10.3322/caac.21660
  3. American Cancer Society. Cancer Facts & Figures 2024. Atlanta, GA: American Cancer Society; 2024. Available from: https://www.cancer.org
  4. Howlader N, Noone AM, Krapcho M, et al., eds. SEER Cancer Statistics Review, 1975–2020. Bethesda, MD: National Cancer Institute; 2023. Accessed May 5, 2025. https://seer.cancer.gov/csr
  5. DeSantis CE, Ma J, Gaudet MM, et al. Breast cancer statistics, 2019. CA Cancer J Clin. 2019;69(6):438–451. doi:10.3322/caac.21583
  6. Prat A, Cheang MCU, Martín M, et al. Prognostic significance of progesterone receptor–positive tumor cells within immunohistochemically defined luminal A breast cancer. J Clin Oncol. 2013;31(2):203–209. doi:10.1200/JCO.2012.43.4134
  7. Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61–70. doi:10.1038/nature11412