News Releases

DCISionRT^® Reclassifies over 50% of DCIS Patients with Low-Risk Clinicopathology into Elevated or Residual Risk Groups Who Benefit Greatly from Radiation Therapy

LAGUNA HILLS, Calif., Oct. 25, 2022 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced study results demonstrating that DCISionRT provides patients with ductal carcinoma in situ (DCIS) superior risk and RT benefit prediction compared to common clinicopathologic features. The data was presented in an oral presentation at the 64^th Annual American Society for Radiation Oncology (ASTRO) Meeting, held on October 23 – 26, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, TX.

This study, titled 'Re-thinking clinicopathologic risk assessment in DCIS: Pooled data from validation studies comparing a 7-gene DCIS assay to clinicopathologic features alone', highlighted that clinicopathologic criteria were poor predictors of 10-year ipsilateral breast recurrence (IBR) rates and radiation therapy (RT) benefit in 926 women from four international cohorts.

"With DCISionRT, clinicians can now identify which DCIS patients, despite having low-risk clinicopathologic features, who can decrease their risk of recurrence by 70% or more with RT after breast conserving surgery. Utilizing this genomic tool, we can also confidently identify a truly Low Risk group of patients who can safely forego RT, even if they have high risk clinicopathologic factors," said Chirag Shah, MD, Co-Director of Comprehensive Breast Program and Director of Clinical Research in the Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH. "It is important to follow the clinical evidence when making the best treatment decisions with our patients. As clinicians, we should not rely on clinicopathologic factors alone, which are inadequate to personalize radiation treatment decisions, especially when compared to the DCISionRT predictive test."

"DCISionRT provides unique game-changing information to enable physicians and DCIS patients to confidently make a personalized treatment decision," said Dan Forche, President and CEO of PreludeDx. "We are honored by the overwhelming recognition of this latest data with oral presentations at three national medical conferences and the recent publication of validation data in ASTRO's prestigious Red Journal."

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman's individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score^™ that identifies a woman's risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT's intelligent reporting provides a woman's recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

PreludeDx is a leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient's treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk^™. PreludeDx is a Fjord Ventures portfolio company.

For more information on how PreludeDx is making a difference for patients, please visit the Company's website: https://preludedx.com and follow us on Twitter @PreludeDx, Facebook, Instagram and LinkedIn.

PreludeDx, the PreludeDx logo, DCISionRT, the DCISionRT logo, DecisionTree, Decision Score, The DCIS Test, Know Your Risk and Your Biology, Your Decision are trademarks of Prelude Corporation or its wholly owned subsidiaries in the United States and foreign countries.

SOURCE PreludeDx