Country for PR: Australia
Contributor: Medianet International
Monday, October 31 2022 - 08:00
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
California, Oct. 28, 2022/Medianet International-AsiaNet/ --

- GenesisCare, a leading provider of integrated cancer care globally, and 
Prelude Corporation (PreludeDx(TM)), a leader in molecular diagnostics and 
precision medicine, today announced interim results from the AUSPREDICT 
registry. 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).

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 

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. 

1. Zissiadis et al. 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 [abstract]. In: Australasian 
International Breast Congress.; October 13-15 2022; Brisbane, Australia.

2. Breast Cancer Network Australia. Understanding breast cancer: Ductal 
Carcinoma In Situ. viewed 11 October 2022.( 

3. Shah et al. The Clinical Utility of DCISionRT(R)
on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ 
Following Breast-Conserving Surgery. Ann Surg Oncol 28, 5974–5984 (2021). 

About GenesisCare

Headquartered in Sydney, Australia, GenesisCare is a global healthcare company 
and one of the world's largest integrated oncology organisations. The company’s 
purpose is to design care experiences that get the best possible life outcomes. 
This is grounded in the belief that care should be focused on the individual, 
not the condition.

GenesisCare is the world's largest provider of radiotherapy – a vital treatment 
option for cancer patients – and provides patients with access to diagnostics, 
medical oncology, surgical oncology, radiotherapy, and novel therapies 
alongside the ability to participate in the latest clinical trials. With a 
growing research and trials program numbering more than 150 clinical trials, a 
contract research organisation, and global innovation programs focused on 
precision medicine and novel therapies, GenesisCare aims to bring new therapies 
to more patients in need in a more affordable way.

Every year, GenesisCare clinical teams see more than 400,000 people across 350+ 
locations, including more than 300 locations in the U.S., 40 in Australia, 14 
in the UK, and 17 in Spain. A further 30 new centres are also under 
development. The organisation employs more than 6,000 highly trained 
physicians, healthcare professionals and support staff across Australia, 
Europe, and the U.S. For more information, visit

About AUS-PREDICT Registry

AUS-PREDICT is a prospective registry study designed to evaluate the effect of 
the DCISionRT test on treatment decisions in patients with DCIS following 
breast conserving therapy. The study will enrol 1500 women across Australia 
onto the registry, who have accessed DCISionRT following surgery.

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 personalised recurrence risk. The test provides a Decision ScoreTM 
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 

Disclaimer: As the test has only recently launched in Australia, it is not 
currently on the Medicare Benefits Scheme or listed on the Therapeutic Goods 
Association (TGA) in Australia. Instead, the patient's tissue sample is sent 
offshore to California to a Prelude’s CAP/CLIA-approved lab for
analysis. The test is frequently used in the USA and many insurers fund the 
test there. Globally, the test is validated by Level 1b clinical evidence which 
is considered to be one of the highest levels of evidence. Health care 
practitioners can access extensive research and findings here:

About PreludeDx

PreludeDx is a leading personalised 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 RiskTM. For more information on how PreludeDx is making a 
difference for patients, please visit the Company’s website: 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. Disclaimer: This information is provided 
for the sole purpose of disseminating general information in relation to