PreludeDx Announces New Response Type Biosignature Data at the 37th Annual Miami Breast Cancer Conference

- New Response Type™ Biosignature Identifies Women at Elevated Risk of Recurrence after Surgery and Radiation Therapy for DCIS

- DCISionRT integration into decision-making changed treatment recommendations in 45% of women with DCIS

- Prospective Trial nears 700 women enrolled

News provided by

PreludeDx

Mar 06, 2020, 07:55 ET

LAGUNA HILLS, Calif., March 6, 2020 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in molecular diagnostics and precision medicine for early stage breast cancer, announced today the presentation of multiple posters at the 37^th Annual Miami Breast Cancer Conference. Prelude's proprietary tests stratify risk of recurrence of ductal carcinoma in situ (DCIS) or progression to invasive breast cancer by assessing tumor biology for an individual patient.

DCISionRT (PRNewsfoto/Prelude Corporation)

A challenge in the care of women with DCIS (often referred to as Stage 0 breast cancer) is early identification of women who may not have the expected response to standard treatments and whose risk of recurrence or progression may remain elevated after treatment. On Thursday evening, Prelude presented information on the development and validation of a Response Type™ biosignature that identifies women at high biological risk (by DCISionRT^®) of recurrence who may not be adequately treated with the current standard of breast conserving surgery and radiation therapy (RT) (p<0.0001) and in whom intensified treatment strategies may be warranted.

Christy Kesslering, MD, radiation oncologist, co-author of the abstract and Medical Director of Radiation Oncology of Northwestern Medicine Radiation Oncology at CDH and Delnor Hospitals stated, "In clinical practice, we have long known that not every woman treated with radiation therapy benefits equally. This new response type biosignature segments patients into distinct groups. Those who are sufficiently treated with standard approaches with a very low 10-year risk of additional breast events and those women who remain at substantial risk of recurrence after treatment. This information will help the oncology community better address the unique treatment needs for every woman."

Daniel Forche, President and CEO of PreludeDx, stated, "We are particularly excited to present the data on the Response Type biosignature as it may have far reaching implications on how a subset of women diagnosed with DCIS may be followed and treated. With the completion of additional validation studies on the horizon, we look forward to making this response type biosignature available to clinicians and patients globally."

Two posters for the prospective clinical utility and decision impact study, The PREDICT Registry, were presented. In an interim analysis of data for 532 patients across 32 sites, physician recommendations for treatment changed in 45% of women after the integration of the DCISionRT Score (DS). For women recategorized from low clinical risk to elevated biological risk by DS, recommendations for RT increased 20%, and for women with low DS recommendations for RT decreased 45%. The PREDICT Registry is still recruiting with current enrollment nearing 700 patients and active involvement of radiation oncologists, surgical oncologists and medical oncologists.

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. 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™ 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 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™.

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, Response Type, The Predictive 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.