PreludeDx Announces DCISionRT™ PREDICT Registry Study

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Apr 25, 2018, 07:10 ET

LAGUNA HILLS, Calif., April 25, 2018 /PRNewswire/ -- Prelude Corporation (PreludeDx), a leader in molecular diagnostics and personalized medicine for early stage breast cancer, announced today the official launch of its large registry study, DCISionRT PREDICT. The study will evaluate the impact of DCISionRT, the prognostic and predictive DCIS test, on clinical management of patients with surgically treated ductal carcinoma in situ (DCIS) as compared to traditional clinical and pathologic risk factors.

According to lead investigator Pat Whitworth, MD, Director of Nashville Breast Center and Chief Science Officer of Breast Care Network, "Recent data presented at SABCS 2017 demonstrated that, using tissue and patient outcomes from the landmark SweDCIS randomized trial, DCISionRT predicted radiation therapy benefit in reducing invasive recurrence, a much anticipated first for genomic testing in DCIS. The next step is to assess the impact of the assay in the broad range of clinical practice settings. The DCISionRT PREDICT study allows physicians across the United States to integrate the DCISionRT test into daily practice while providing data on how the assay impacts surgical and therapeutic decision-making. The study represents an important step in clinical evidence development for a test that has practice-changing potential and which may finally enable us to realize the goal of personalized DCIS management."

Daniel Forche, President and CEO of PreludeDx, stated, "We are proud to sponsor the DCISionRT PREDICT study and excited about the clinical evidence it will provide for patients, physicians and payers. The scope of the study is substantial—it will enroll up to 2,500 patients at 100 sites over the next 12-18 months and demonstrate the impact DCISionRT has on DCIS treatment. We will be working with top academic and community cancer centers to gather this important data and ensure patients and their breast cancer physicians can have an accurate assessment of recurrence risk and therapeutic benefit before making a treatment decision. We know that these decisions are critical to patient care, and we believe it is important to have the best information available and for each women to know her DCIS risk as well as therapeutic benefit."

For more information about the Prospective Registry study to Evaluate the effect of the DCISionRT test on treatment Decisions In patients with DCIS following breast Conserving Therapy, or DCISionRT PREDICT, please email [email protected] or visit clinicaltrials.gov (NCT03448926)

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^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 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