With technological advancements, medical diagnosis has been experiencing groundbreaking progress in redefining the way breast cancer is diagnosed and evaluated. PreludeDx stands at the forefront of this technological advancement in medical diagnostics, helping patients make the best treatment decisions for their breast cancer. Recognizing the patient behind each sample, the laboratory excels in improving patient outcomes.
Having been recognized as one of the “Most Innovative Companies to Watch 2025” by The CEO Views, Dan Forche, President and CEO of PreludeDx, takes pride in the achievement of the laboratory in redefining breast cancer treatment decisions.
A Value-driven Mission
Driven by the purpose of delivering better breast cancer decision-making tools, PreludeDx was built on the principle of considering each sample with a patient behind it. Its mission is to make precision diagnostic testing accessible to all patients and help physicians make informed treatment decisions. The goal of the laboratory is to improve patient outcomes in breast cancer and reduce the overall healthcare cost burden.
PreludeDx carries out its operations by remaining patient-focused, keeping quality at the forefront, and driving innovation. It focuses on delivering timely results to patients and physicians by handling each sample with utmost care.
Identifying Gaps in Traditional Clinical Approaches
Studies have shown that more than 50,000 women are diagnosed with ductal carcinoma in situ (DCIS) each year, which makes navigating treatment decisions challenging with the lack of personalized tools. Traditional approaches that rely on clinical pathology frequently miss the mark in their ability to identify which patients will benefit from radiation therapy after breast-conserving surgery.
This one-size-fits-all methodology creates a significant dilemma. Under this approach, many women may endure unnecessary treatment with its accompanying side effects, while others may not receive the treatment they need. This is where DCISionRT® comes in. The test provides personalized information on a woman’s tumor biology to avoid over- or undertreatment, and aids in shared treatment decision-making.
Redefining Breast Cancer Treatment Decisions
DCISionRT® was developed specifically to address the clinical gap in accurately identifying a woman’s risk of their cancer recurring and their treatment response to radiation therapy. As the only risk assessment test on the market capable of predicting radiation therapy benefits, DCISionRT® has changed DCIS treatment planning. It is a blend of the latest innovations in molecular biology with artificial intelligence (AI) and machine learning (ML) to offer the most advanced DCIS test accessible for all patients.
The impact of DCISionRT® is substantial, as more than 35,000 patients have benefited from this precision diagnostics approach. Studies involving over 3,500 patients have provided compelling evidence to support its effectiveness, extensive validation, and clinical utility.
Unveiling DCISionRT®
The development of DCISionRT® began in 2009, incorporating technology licensed from the University of California, San Francisco, and was built on research funded by the National Cancer Institute. The test combines the molecular assessment of a woman’s individual tumor biology along with other pathologic risk factors to provide a personalized recurrence risk.
This test also provides a score that identifies a woman’s risk as low, elevated, or residual. Unlike other risk assessment tools, the DCISionRT® test combines protein expression from seven biomarkers and four clinicopathologic factors. It uses a non-linear algorithm to account for multiple interactions between individual factors to better interpret complex biological information.
“Precision medicine tools like DCISionRT® ensure patients are not being overtreated or undertreated,” says Dan Forche. He continues to articulate that the test provides information on a patient’s tumor biology that helps physicians tailor both surgical and radiation treatment decisions. It helps mitigate unnecessary procedures, benefiting both the patient and the healthcare system.
Awards and Accolades
In 2025, PreludeDx received FDA Breakthrough Device Designation for DCISionRT®. This designation is reserved for novel technologies that offer significant advantages over existing approved or cleared alternatives and will help patients have more timely access to DCISionRT®. But what places PreludeDx among one of the “Most Innovative Companies to Watch 2025” is not just its current achievements but its forward-thinking personalized approach to technology integration.
The DCISionRT® test was recently approved for a national randomized trial (CC-016) through the NRG Breast Cancer Committee and the NCI. NRG Oncology is one of four cooperative cancer research groups advancing the care of adults with malignancies and funded by the NCI. Its mission is to improve the lives of patients with cancer by conducting practice-changing multi-institutional clinical and translational research to inform clinical decision making and healthcare policy.
What’s Next for PreludeDx?
While talking about embracing advanced technologies in redefining breast cancer treatment decisions, Forche pointed out leveraging technologies like AI and ML, among numerous other technologies. In his view, these technologies have remained instrumental in refining the diagnostic algorithms of PreludeDx, which enhance the accuracy and reliability of its tests.
This commitment to using new technology reflects the company’s strategy for maintaining its competitive edge. Building on the success of DCISionRT®, PreludeDx is expanding its portfolio with the launch of AidaBreast, a next-generation multi-omic assay for Stage I and IIa invasive breast cancer. The test employs a sophisticated platform that combines proteomic and genomic analyses with spatial biology for comprehensive risk assessment and treatment guidance.
Shedding light on this new initiative, Forche says, “Initially, AidaBreast will predict radiation therapy (RT) benefit.” Soon after, the lab expects to answer additional therapeutic questions, such as the ability to predict the benefit of endocrine therapy (ET) and more, so it can significantly increase its clinical impact across the breast cancer spectrum. Looking ahead, PreludeDx envisions becoming a comprehensive resource for breast cancer treatment decisions.
The future of PreludeDx is to be a one-stop shop for precision-based testing to help breast surgeons, medical oncologists, and radiation oncologists tailor treatments to the specific needs of patients, ultimately improving outcomes and quality of life.