PreludeDx has received breakthrough device designation from the US Food and Drug Administration (FDA) for its DCISionRT test.
DCISionRT offers personalised risk assessment for women with ductal carcinoma in situ (DCIS), commonly referred to as Stage 0 breast cancer. It also predicts the benefit of radiation therapy (RT) on these patients.
By combining tumour biology and clinicopathologic factors, the test delivers personalised results and advance DCIS patient care.
PreludeDx, a precision diagnostics company focused on early-stage breast cancer, said that the test analyses seven protein biomarkers and four clinical factors to generate a Decision Score. It classifies a patient’s risk as low, elevated, or residual.
This score helps doctors determine which patients will benefit most from RT, reducing the risks of over- or under-treatment. The test uses a non-linear algorithm to interpret complex biological data.
DCISionRT is designed for women aged 30-85 with DCIS. It predicts the benefit of radiation therapy after breast conserving surgery (BCS).
It also provides prognostic insights for 10-year breast cancer recurrence risk. Additionally, the test identifies patients with residual risk, even after BCS and radiation therapy.
The precision diagnostics company developed the test using technology licensed from the University of California San Francisco and supported by National Cancer Institute funding.
PreludeDx president and CEO Dan Forche said: “DCISionRT addresses an unmet need for DCIS patients by answering the questions, ‘Do I need radiation therapy?’, and ‘will I benefit?’.
“DCISionRT helps patients and their physicians to make a better and more informed treatment decision.”
In October 2024, PreludeDx announced study results on HER2-positive DCIS patients. The study found that patients with the DCISionRT Residual Risk subtype had significantly higher in-breast recurrence (IBR) rates compared to those without this subtype.
PreludeDx is focused on developing precision breast cancer tools that guide treatment decisions. The company aims to provide new technologies that enhance patient outcomes while reducing the overall healthcare cost burden.
Furthermore, the diagnostics company is developing the AidaBreast test which is designed to predict 10-year recurrence rate and radiation therapy (RT) benefit.
AidaBreast will offer personalised testing for the broader Stage I and IIA breast cancer market.
