Each year, more than 50,000 women are diagnosed with ductal carcinoma in situ (DCIS), a non-invasive type of breast cancer. Even though DCIS can’t go outside the breast, it can’t be left alone because some DCIS cells could morph and turn into invasive breast cancer.
Typically, a woman with DCIS is treated with breast conserving surgery (BCS). The next decision she has to make is whether or not to get radiation therapy (RT). Traditionally, this decision was guided by her doctor’s advice, who made a recommendation based on clinical pathology (such as tumor grade, size and margin status).
But recently, major clinical studies have proven that relying on these clinical pathology factors alone has failed to identify patients who could safely omit RT after BCS. While RT can effectively reduce the risk of recurrence for some women, others with low-risk DCIS may not derive significant benefit and may be exposed to unnecessary radiation and its associated side effects. Conversely, omitting RT in women with higher-risk DCIS could lead to undertreatment and an increased risk of recurrence.
PreludeDx is changing the way physicians and patients approach DCIS treatment decisions with DCISionRTÆ, a test proven to predict who is most likely to benefit from RT post BCS, based on an analysis of each patient’s unique tumor biology. This is the only test on the market that predicts the benefit of radiation therapy in DCIS breast cancer.
The test allows physicians to tailor treatment decisions, helping to avoid over- and undertreatment. Results from a DCISionRT test, categorized as low, elevated or residual risk, provide a clear, easy-to-interpret risk assessment, fostering more productive conversations between patients and their physician care team, typically consisting of a breast surgeon and a radiation oncologist.
For women identified as low risk, the test may offer the reassurance of omitting radiation therapy while maintaining a high probability of a cancer-free future. For those with elevated or residual risk, the test may confirm the need for additional therapies to optimize treatment plans and ultimately improve outcomes.
“Breast surgeons and radiation oncologists are using DCISionRT results to guide treatment decisions,” says Dan Forche, President and CEO of PreludeDx. “They trust our company because we give them the information they need to tailor their treatment options, according to a patient’s unique tumor biology.”
A Mission Rooted in Precision
Founded in 2009, PreludeDx’s mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden on the healthcare system.
“We are dedicated to serving breast cancer patients and physicians worldwide,” Forche says. “Our company has also embraced AI and machine learning to enhance the accuracy and reliability of our tests. These technologies are instrumental in refining our novel algorithms, which enhance the accuracy and reliability of our tests.”
The company’s dedication to precision medicine is ingrained in the company’s DNA. PreludeDx was born out of technology licensed from the University of California, San Francisco.
“Current trends are to move testing toward precision-based medicine,” Forche says. “No longer is cancer treatment an all-or-nothing approach. Not everyone needs chemotherapy; not everyone needs radiation therapy.”
Forche proves that point by sharing a testimonial from a patient whose life was transformed by her DCISionRT results. Her score came back as 0.8, in the low-risk category, indicating there was no additional benefit from radiation therapy. This information allowed her to make an informed decision against having a full mastectomy, bringing immense relief and potentially sparing her from unnecessary treatment.
“I wanted to share some good news and express my gratitude for your assistance in getting the DCISionRT test done for me,” she wrote. “Since my diagnosis, I have been agonizing over the standard of care treatment options that had been presented to me. I was able to get the test results a week before my scheduled mastectomy surgery. The results of this test saved me from what I felt was an over-treatment of my DCIS.”
What’s Next?
PreludeDx remains at the forefront of breast cancer diagnostics, continually refining and improving its offerings. In 2025, they’ll launch AidaBreastÆ, which is a test for Stage I and Stage IIa breast cancer.
AidaBreast represents a significant step forward, powered by a multi-omic platform that uses proteomic and genomic analyses. This approach promises to offer even more personalized and comprehensive risk assessments for breast cancer patients.
“The first test in the AidaBreast portfolio will be for the assessment of radiation therapy benefit,” Forche says. “Further tests will answer additional therapeutic questions, so we can significantly increase our clinical impact in the broader breast cancer market.”
PreludeDx’s movement into the broader breast cancer market will put a big emphasis on the importance of shared decision-making between patients and doctors.
“This expansion is part of PreludeDx’s strategy to increase its clinical impact across the breast cancer spectrum,” Forche says. “We want to continue to provide novel tools that allow for a tailored treatment approach personalized to the needs of patients, ultimately improving outcomes and quality of life.”
