DCISionRT® by PreludeDx™ Identifies Breast Cancer Patients Who May Be Undertreated with Surgery Alone

Data presented at ASTRO 2020 National Meeting

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Oct 29, 2020, 14:48 ET

LAGUNA HILLS, Calif., Oct. 29, 2020 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in molecular diagnostics and precision medicine for early stage breast cancer, presented pivotal data at the American Society of Radiation Oncology (ASTRO) 2020 National Meeting on the company's present commercially available test, DCISionRT^®; as well as its new genomic signature presently in development for women with invasive breast cancer (IBC).

ASTRO Poster #2034, entitled Age and Grade as a Function of Decision Score in Women Diagnosed with DCIS, included nearly 1,800 women diagnosed with ductal carcinoma in situ (DCIS) and classified as clinicopathologically low-risk by RTOG-like criteria for recurrence of DCIS or progression to IBC. The DCISionRT assay reclassified almost half of these patients to elevated risk, suggesting a group of patients who would be under treated with surgery alone.

Furthermore, the data suggest both patient age and tumor grade failed to sufficiently risk stratify patients. DCISionRT Decision Score (DS) for women under 50 years of age classified 48% of the women to be very low and 52% to be very high biological risk of DCIS recurrence or progression to IBC over 10 years. This differs from the common expectation that the majority of women under 50 are at high risk and should therefore all undergo radiation post-surgery.

Additionally, almost half (48%) of women with low to intermediate tumor grade were reclassified as elevated risk by DCISionRT for DCIS recurrence or progression to IBC, thereby making tumor grade also inadequate as an independent risk indicator.

ASTRO Poster #2041, entitled A Novel Biosignature to Assess Residual Risk in Early Stage Invasive Breast Cancer after Standard Breast Conserving Surgery, provides new data to the company's biosignature that identifies which women diagnosed with stage 1 or 2 invasive breast cancer are most likely to have excellent versus poor outcomes after breast conserving surgery and radiation.

"It is heartening to see such robust data in support of DCISionRT testing to help physicians make treatment decisions for DCIS patients based on their own unique tumor biology instead of relying primarily on clinical features such as age and tumor grade," says Frank A. Vicini, MD, FACR, FASTRO, radiation oncologist at 21^st Century Oncology. "Additionally, I am excited about the promising data from the new biosignature for invasive breast cancer patients and look forward to the additional clinical benefits this will provide."

"We continue to remain laser focused on helping patients with early stage breast cancer determine the optimal treatment based on each woman's unique biology of her cancer tumor," says Dan Forche, President and CEO of PreludeDx. "Today, we help patients and their physicians make the most personalized treatment decision at time of DCIS diagnosis with our commercially available DCISionRT product, and in the future, we look forward to helping patients diagnosed with invasive breast cancer do the same with products in our development pipeline."

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. In the US, over 60,000 women are newly diagnosed with DCIS each year. The test was developed by PreludeDx and built on research that began with funding from the National Cancer Institute to better understand the biology of DCIS. DCISionRT assesses a woman's individual tumor biology along with other risk factors to provide a personalized recurrence risk. The test provides a Decision Score™ 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 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™.

For more information on how PreludeDx is making a difference for patients, please visit the Company's website: www.preludedx.com

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.

CONTACT: Cory Dunn 888-211-DCIS(3247) [email protected]

SOURCE PreludeDx