GenesisCare and PreludeDx(TM) Present Compelling First Interim Analysis of Australia’s DCISionRT Study During Breast Cancer Awareness Month 45% Change in Treatment Recommendations While Using DCISionRT

CALIFORNIA CITY, CA., October 30, 2022 /PRNewswire/ — GenesisCare, a leading global provider of comprehensive cancer care, and Prelude Corporation (PreludeDx(TM)), a leader in molecular diagnostics and precision medicine, today announced results provisional from the AUSPREDICT register. Data presented at the Australasian International Breast Congress demonstrates a significant change (45%) in radiotherapy treatment recommendations1 when using the DCISionRT test, thereby optimizing management to prevent overtreatment and undertreatment of Australian women with ductal carcinoma in situ (DCIS).

DCIS is a pre-invasive breast disease that can lead to invasive breast cancer if left untreated.(2) After breast-conserving surgery (BCS) for DCIS, radiation therapy is often used to minimize the risk of recurrence. DCISionRT(R) is a new molecular test that assesses the risk of recurrence over 10 years after BCS and whether there would be a benefit to treating with radiotherapy. GenesisCare and PreludeDx have 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, titled Interim Analysis of the PREDICT Registry Australia: Changes in Treatment Recommendation for a Biological Signature Predictive of Radiation Therapy (RT) Benefit in Patients with DCIS, studied 232 patients from Australia who had received the DCISionRT test after breast-conserving surgery. Radiation therapy recommendation decreased by 70% in patients with low-risk DCISionRT score and increased by 29% in patients with high-risk scores.(1)

Chief Breast Surgeon Specialist and Director of Breast Cancer Services for royal melbourne and female royal Hospital, Melbourne, Professor Bruce Mannsaid, “Historically, we have relied on clinical pathology, such as tumor grade and size, to determine treatment plans for patients with DCIS. These data demonstrate that the integration of DCISionRT into clinical decision-making has a substantial impact on RT recommendations and has the ability to prevent overtreatment and undertreatment of patients with DCIS.”

GenesisCare Principal Investigator and Radiation Oncologist, Dr. Yvonne Zissiadissaid the interim results “demonstrate the critical role of DCISionRT in the clinical treatment journey of patients with DCIS, ensuring women receive the right treatment at the right time.” Our study underscores 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 biorisk profile.

“GenesisCare, in partnership with PreludeDx, is delighted to present interim results from our first Australian study,” continued Dr Zissiadis.

“AUS-PREDICT’s first interim analysis is highly consistent with the US-PREDICT3 registry which has completed enrollment of 2,500 patients,” said Troy Bremer, PhD, scientific director of PreludeDx. “In registry studies in both countries, DCISionRT was the most influential single factor in changing treatment recommendations regarding radiation therapy after breast-conserving surgery,” Dr. Bremer continued.

“We are excited to bring precision medicine to Australian women diagnosed with DCIS and to continue their enrollment in the AUS-PREDICT registry. We look forward to the continued expansion of our global data and clinical evidence network for DCISionRT,” said Dan ForcheCEO of PreludeDx.

References

  1. Zissiadis et al. PREDICT Australia Registry Interim Analysis: Changes to Treatment Recommendations for a Predictive Biological Signature of Radiation Therapy (RT) Benefits in Patients with DCIS [abstract]. In: Australasian International Breast Congress.; October 13-15, 2022; Brisbane, Australia.
  2. Australian Breast Cancer Network. Understanding breast cancer: ductal carcinoma in situ. seen October 11, 2022.(https://www.bcna.org.au/understanding-breast-cancer/what-isbreast-cancer/ductal-carcinoma-in-situ/)
  3. Shah et al. The clinical utility of DCISionRT(R) on radiotherapy decision-making in patients with ductal carcinoma in situ after breast-conserving surgery. Ann Surg Oncol 28, 5974–5984 (2021).

About Genesis Care

Based at Sydney, Australia, GenesisCare is a global healthcare company and one of the world’s largest integrated oncology organizations. The company’s goal is to design care experiences that achieve the best possible life outcomes. This is based on the belief that care should be focused on the individual, not the condition.

GenesisCare is the world’s largest provider of radiation therapy – a vital treatment option for cancer patients – and provides patients with access to diagnostics, medical oncology, surgical oncology, radiation therapy and new therapies , as well as the opportunity to participate in the latest clinical trials. With a growing research and trials program of more than 150 clinical trials, a contract research organization, and global innovation programs focused on precision medicine and new therapies, GenesisCare aims to bring new therapies to more patients in need more affordably.

Each year, GenesisCare clinical teams see more than 400,000 people at more than 350 sites, including more than 300 sites in the United States, 40 in Australia14 in the UK and 17 in Spain. 30 other new centers are also under development. The organization employs more than 6,000 highly trained physicians, healthcare professionals and support staff across Australia, Europeand the United States For more information, visit www.genesiscare.com

About the AUS-PREDICT registry

AUS-PREDICT is a prospective registry study designed to assess the effect of the DCISionRT test on treatment decisions in patients with DCIS after breast-conserving therapy. The study will recruit 1,500 women across Australia on the registry, who accessed DCISionRT after surgery.

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts the benefit of radiation therapy. Patients with DCIS have cancer cells lining the milk ducts of the breast, but they have not spread to surrounding breast tissue. In the United States, more than 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from University of California San Francisco, and building on research that began with funding from the National Cancer Institute, helps doctors 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 as well as other disease risk factors and provide personalized recurrence risk. The test provides a Decision Score™ which identifies a woman’s risk as low or high. DCISionRT’s smart reports provide a woman’s risk of recurrence after breast-conserving surgery alone and with the addition of radiation therapy. In turn, this new information can help patients and their doctors make more informed treatment decisions.

Disclaimer: Since the test was only recently launched in Australiait is not currently on Medicare or listed on the Therapeutic Goods Association (TGA) in Australia. Instead, the patient’s tissue sample is sent overseas for California to a Prelude CAP/CLIA accredited laboratory for analysis. The test is frequently used in the UNITED STATES and many insurers finance the test there. Overall, the test is validated by Level 1b clinical evidence which is considered one of the highest levels of evidence. Healthcare professionals can access extensive research and findings here: https://preludedx.com/our-publications/

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 is 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 on the healthcare system. Before making a treatment decision, Know Your RiskTM. 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 United States and foreign countries. Disclaimer: This information is provided for the sole purpose of disseminating general information regarding DCISionRT.

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