PreludeDx Unveils Predictive Assay in DCISionRT Breast DCIS Test at SABCS

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Dec 13, 2017, 08:33 ET

LAGUNA HILLS, Calif., Dec. 13, 2017 /PRNewswire/ -- Prelude Corporation (PreludeDx), a leader in molecular diagnostics and personalized medicine for early stage breast cancer, announced today the results from last week's oral presentation at the San Antonio Breast Cancer Symposium. The results utilizing the SweDCIS randomized trial confirmed that DCISionRT™—The DCIS Test™—predicts which patients with ductal carcinoma in situ (DCIS) will benefit from radiation therapy after breast conserving surgery.

The results shared by Principal Investigator of SweDCIS, Fredrik Wärnberg MD PhD, Associate Professor of Surgery at Uppsala University, demonstrated that the DCISionRT test accurately stratified patients from the landmark trial into two groups: (1) a low risk group that did not benefit from radiation therapy, and (2) an elevated risk group with a highly significant 9% absolute benefit from radiation therapy. According to Rakesh Patel MD, a leading breast cancer radiation oncologist and Medical Director of Breast Cancer Services at Good Samaritan Hospital in Los Gatos, CA, "The use of DCISionRT in this randomized trial set demonstrated twice the benefit of radiation compared to all other previous DCIS trials investigating radiation therapy benefit. This is big news to radiation oncologists and surgeons worldwide and will impact the way DCIS is managed moving forward."

Daniel Forche, PreludeDx President and CEO stated, "We are delighted that DCISionRT is the only DCIS test with level 1B evidence showing predictive value to physicians and patients about whether radiation therapy will provide benefit post breast conserving surgery. SweDCIS is the third validation we have performed and brings the total number of patients to more than 1,500 across all validation studies. The take home from these studies is that the DCISionRT test has been proven to be consistent, accurate and reproducible in each validation set. Our hope is that before a woman makes a critical treatment decision, she asks her physican about DCISionRT—The DCIS Test™— and knows her risk."

PreludeDx plans to continue the unveiling of its powerful data throughout 2018 by sharing multiple studies and data insights that positively impact women with DCIS.

About DCISionRT for Breast DCIS
DCISionRT is a risk assessment test for patients with ductal carcinoma in situ (DCIS). In the US, over 60,000 women are newly diagnosed with DCIS each year. The test was developed by PreludeDx and built on research that began with funding from the National Cancer Institute to better understand the biology of DCIS. DCISionRT assesses a woman's individual tumor biology along with other risk factors to provide a personalized recurrence risk. The test provides a Decision Score^TM that identifies a woman's risk as low or elevated. 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.

About the SweDCIS Randomized Clinical Trial
SweDCIS is a landmark randomized clinical trial organized by the Swedish Breast Cancer Group. The study enrolled 1,046 patients with breast DCIS between 1987 and 1999. DCIS patients in the study were all treated with breast conserving surgery and then randomized to receive radiation therapy or not. SweDCIS is one of only four DCIS studies ever designed to investigate the benefit of radiation therapy in a randomized trial without hormone therapy. This study design constitutes level 1B evidence for DCISionRT.

About PreludeDx
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^TM.

For more information on how PreludeDx is making a difference for patients, please visit the Company's website: www.preludedx.com

PreludeDx, the PreludeDx logo, DCISionRT, the DCISionRT logo, 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