PreludeDx™ Presents DCIS Patient Data Comparing Clinicopathological Risk Factors to DCISionRT®
PREDICT Registry Meets Phase One Accrual Goal of 2,500 Patients; Largest Ongoing Prospective Ductal Carcinoma in Situ Study in the World
LAGUNA HILLS, Calif., March 3, 2022 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced it will be presenting data comparing DCISionRT® and its integrated Residual Risk subtype (RRt) with traditional clinicopathology features at the 39th Annual Miami Breast Cancer Conference (MBCC), being held on March 3 – 6, 2022 at the Fontainebleau Miami Beach.
The poster is entitled, 'Clinicopathological Risk Factors Poorly Stratified Baseline Risk and RT Benefit Compared to DCISionRT in Patients with Ductal Carcinoma in Situ' and will be available online for viewing during the duration of the conference and available in-person during the poster receptions on March 3rd and 4th. The study included 493 patients from three cohorts who were treated with breast conserving surgery (BCS) or BCS + radiation therapy (RT). DCISionRT and its RRt classified patients into Low, Elevated and Residual Risk groups with the Residual Risk group having the highest 10-year ipsilateral breast recurrence (IBR) risk without RT and significantly elevated IBR risk even after RT. In comparison, the distribution of clinicopathological features varied between biosignature Risk groups but were not significantly associated with 10-year IBR risk.
"Traditional clinicopathologic features fail to stratify patients appropriately," said Pat Whitworth, MD, FACS, Principal Investigator and Breast Surgical Oncologist Director, Nashville Breast Center; Managing Partner TME. "When routinely implemented in practice, DCISionRT can reduce over- and under- treatment of DCIS patients."
"The DCISionRT test with its integrated Residual Risk Subtype helps to tailor treatment for DCIS patients. For the first time, there is a personalized medicine tool that identifies which patients benefit from RT and discriminates between patients who have a low or elevated risk of recurrence after lumpectomy and RT," said Rachel Rabinovitch, MD, Professor, Radiation Oncology, University of Colorado.
"We are pleased to share our latest data demonstrating the clinical significance of DCISionRT and its integrated Residual Risk Subtype. This new data enables clinicians to further stratify recurrence risk and treatment benefit for patients with DCIS," says Dan Forche, President and CEO of PreludeDx.
Additional MBCC Poster Presentations Include:
Posters will be available online for viewing during the duration of the conference and available in-person during the poster receptions on March 3rd and 4th.
Encore Poster entitled Interim Analysis of the PREDICT Registry: Changes in Treatment Recommendation for a Biologic Signature Predictive of Radiation Therapy (RT) Benefit in Patients with DCIS.
The PREDICT study is a prospective, multi-institutional registry for patients who received DCISionRT testing as part of their routine care. Interim analysis reveals that RT recommendations were changed for 40% of women after DCISionRT testing. RT recommendations decreased by 42% in DS Low risk patients but increased 22% in DS Elevated risk patients.
On January 4, 2022, the study met its phase one accrual goal of 2,500 patients from 67 institutions. Additional research objectives are being planned and accrual is scheduled to reopen around mid-year 2022.
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.
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