PreludeDx™ Presents DCIS Precision Medicine Study Results at ASTRO 2021 Annual Meeting

DCISionRT® and its Response Subtype Identifies DCIS Patients with Unacceptably Elevated Risk of Local Recurrence after Breast Conserving Surgery and Radiation Therapy

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PreludeDx

Oct 27, 2021, 07:00 ET

LAGUNA HILLS, Calif., Oct. 27, 2021 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, presented data in an oral scientific session presentation at the American Society for Radiation Oncology (ASTRO) 63^rd Annual Meeting held October 24 – 27, 2021 at McCormick Place West in Chicago, IL. Data presented demonstrates use of DCISionRT^® and its response subtype (Rst) was able to identify women with ductal carcinoma in situ (DCIS) (Stage 0 breast cancer) who remain at an elevated risk of recurrence despite receiving breast conserving surgery (BCS) and radiation therapy (RT).

ASTRO Presentation #513, entitled Biosignatures to Optimize Adjuvant Radiation Therapy Use in Patients with DCIS with High Risk Clinicopathologic Features examined 485 women diagnosed with DCIS and treated with BCS, with or without RT. The study examined the utility of DCISionRT and its response subtype by classifying these women into three risk groups: Low Risk—those who could safely omit RT, Elevated Risk with Good Rst—those who benefited significantly from RT, and Elevated Risk with Poor Rst—those with increased recurrence rates post-treatment with BCS and RT who may need alternative therapeutic strategies beyond standard treatment.

"Women classified into the Elevated Risk group with Good Rst by DCISionRT had significant benefit from adjuvant radiation, with 10-year risk reduced to 5%," said Dr. Frank Vicini, Radiation Oncologist at GenesisCare, member of NRG Oncology, and presenter of the study. "However, patients classified into the Elevated Risk group with a Poor Rst had a 25% risk of recurrence at 10 years despite being treated with both BCS and adjuvant RT."

"For the first time, this study demonstrates the ability to identify patients who have high recurrence risk after BCS and RT," said study investigator Chirag Shah, MD, Director of Breast Radiation Oncology, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH. "This additional information is critical and will help guide treatment decisions, since Elevated Risk with Poor Rst patients may benefit from supplemental therapeutic strategies."

"Our ongoing clinical studies reinforce the medical need for personalized treatment decisions for women upon a DCIS diagnosis," says Dan Forche, President and CEO of PreludeDx. "Our widely accessible DCISionRT test gives physicians and their patients the utmost confidence in their DCIS treatment decisions. As we continue the development of our precision testing pipeline, including our response subtype biosignature, we look forward to delivering predictive tools that positively impact treatment decisions and provide peace of mind to even more patients with early-stage breast cancer."

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. 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.

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™. 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, 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.