PreludeDx™ Announces Publication of Residual Risk after Radiation Therapy Data in the International Journal of Radiation Oncology•Biology•Physics

DCISionRT® is the First and Only Test to Identify DCIS Patients with Unexpectedly High Residual Risk after Surgery and Radiation

LAGUNA HILLS, Calif., Sept. 20, 2022 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced the publication of clinical study data in the International Journal of Radiation Oncology· Biology· Physics ("Red Journal"). The study demonstrated that the DCISionRT® Residual Risk Subtype (RRt) identified ductal carcinoma in situ (DCIS) patients who had a much higher recurrence risk following breast conserving surgery (BCS) and radiation therapy (RT). The risk profile of these patients may warrant intensified or alternative therapy considerations.

This study, titled 'A novel biosignature identifies patients with DCIS with high risks of local recurrence after breast conserving surgery and radiotherapy', evaluated 10-year recurrence risk in 926 women diagnosed with DCIS and treated with BCS with or without RT. Patients in the RRt group had a 42% risk of recurrence after BCS and a significantly elevated recurrence rate of 14.7% after BCS and RT.

"DCISionRT can help identify those women who may benefit from intensified or alternate therapy as they have an unexpectedly high recurrence risk following standard-of-care therapy for DCIS," said Frank Vicini, MD, Radiation Oncologist at GenesisCare, member of NRG Oncology, and co-first author of the study. "This study demonstrates new utility and evidence to provide DCIS patients and their physicians unique and valuable information beyond clinical and pathologic features to determine treatment decisions based on a woman's personal tumor biology."

"Knowing if a patient will have minimal or significant benefit from radiation therapy or if she may need more intensified treatment, helps me and my colleagues deliver truly personalized treatment to our DCIS patients," said Julie A. Margenthaler, MD, FACS, Professor of Surgery, Washington University School of Medicine, and a coauthor of the study. "DCISionRT is an extremely valuable test for surgical and adjuvant (post-surgical) treatment planning."

"We are grateful for the multi-national collaboration culminating in results published in ASTRO's official scientific journal," said Dan Forche, President and CEO of PreludeDx. "The Residual Risk Subtype is an important advancement for patients and physicians strengthening our commitment to help guide optimal DCIS patient management with our proprietary DecisionTree^TM risk profile and treatment outcomes."

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^TM 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