GenesisCare and PreludeDx(TM) present compelling Australian-first DCISionRT Study Interim Analysis during Breast Cancer Awareness Month 45% change in treatment recommendations when using DCISionRT

On October 30, 2022 GenesisCare, a leading provider of integrated cancer care globally, and Prelude Corporation (PreludeDx(TM)), a leader in molecular diagnostics and precision medicine, reported interim results from the AUSPREDICT registry (Press release, GenesisCare, OCT 30, 2022, https://www.prnewswire.com/news-releases/genesiscare-and-preludedxtm-present-compelling-australian-first-dcisionrt-study-interim-analysis-during-breast-cancer-awareness-month-45-change-in-treatment-recommendations-when-using-dcisionrt-301662105.html [SID1234622599]). Data presented at the Australasian International Breast Congress demonstrates a significant (45%) change in radiation therapy treatment recommendations1 when using the DCISionRT test, optimising management to prevent over and under treatment of Australian women with Ductal Carcinoma In Situ (DCIS).

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DCIS is a pre-invasive disease of the breast that may lead to invasive breast cancer if untreated.(2) After breast conserving surgery (BCS) for DCIS, radiation therapy is often used to minimise the risk of recurrence. DCISionRT(R)is a novel molecular test that assesses the 10-year risk of recurrence after BCS and if there would be a benefit to treating with radiation therapy. GenesisCare and PreludeDx formed a strategic partnership in 2021 to bring DCISionRT to Australia for the first time and establish the AUS-PREDICT registry to collect real-world data to further the development of precision medicine and decision tools globally.

The presentation, entitled Interim Analysis of the PREDICT Registry Australia: Changes in Treatment Recommendation for a Biologic Signature Predictive of Radiation Therapy (RT) Benefit in Patients with DCIS, studied 232 patients from Australia who had received the DCISionRT test following breastconserving surgery. Radiation therapy recommendation decreased by 70% in patients with a low risk DCISionRT score and increased 29% in patients with elevated risk scores.(1)

Leading Specialist Breast Surgeon and Director of Breast Cancer Services for Royal Melbourne and Royal Women’s Hospital, Melbourne, Professor Bruce Mann, said: "Historically, we have relied on clinical pathology, such as tumour grade and size, to determine treatment plans for patients with DCIS. This data demonstrates the integration of DCISionRT into clinical decision making has a substantial impact on RT recommendations and has the ability to prevent over and under treatment of DCIS patients."

Principal Investigator and GenesisCare Radiation Oncologist, Dr Yvonne Zissiadis, said the interim results "demonstrate the critical role of DCISionRT in the clinical treatment pathway for DCIS patients, ensuring women receive the right treatment at the right time. "Our study highlights that DCISionRT is a promising predictive tool, arming clinicians and patients with the information to make informed decisions about treatment options based on a patient’s individual biological risk profile."

"GenesisCare, in partnership with PreludeDx, is thrilled to present the interim findings from our Australian-first study," continued Dr Zissiadis.

"The first interim analysis of AUS-PREDICT is highly consistent with the US-PREDICT registry3 that has completed enrollment of 2,500 patients," said Troy Bremer, PhD, Chief Scientific Officer of PreludeDx. "In the registry studies in both countries, DCISionRT was the most impactful single factor for changing treatment recommendations regarding radiation therapy following breast conserving surgery," continued Dr. Bremer.

"We are delighted to bring precision medicine to Australian women diagnosed with DCIS and further enrollment in the AUS-PREDICT registry. We look forward to the continued expansion of our global data network and clinical evidence for DCISionRT," said Dan Forche, CEO of PreludeDx.