FDA Grants Breakthrough Status to DCISionRT Test in DCIS
The FDA has granted breakthrough therapy designation to the DCISionRT test, a tool that assesses radiation therapy benefit for women aged 30 to 85 with ductal carcinoma in situ.
- The FDA has granted breakthrough therapy designation to the DCISionRT test for patients with ductal carcinoma in situ (DCIS).
- The DCISionRT test is an individualized risk assessment tool that helps predict the benefit of radiation therapy.
- The test is designed for women aged 30 to 85 with DCIS.
The FDA has granted breakthrough therapy designation to the DCISionRT test, an individualized risk assessment tool designed to predict the benefit of radiation therapy and provide prognostic insights for patients with DCIS.1
The test evaluates protein expression from 7 biomarkers and 4 clinical factors to produce a Decision Score, enabling physicians to determine which patients are most likely to benefit from RT and aiding in the reduction of both overtreatment and undertreatment.
3D rendering of breast cancer: © Giovanni Cancemi - stock.adobe.com
The device is intended for women aged 30 to 85 following breast-conserving surgery (BCS). It identifies patients with residual risk after BCS and provides a prognosis for their 10-year risk of breast cancer recurrence.
“DCISionRT addresses an unmet need for [patients with] DCIS 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,” said Dan Forche, president and chief executive officer of PreludeDx, in a press release. “We will continue to work closely with the FDA, and we remain committed to providing access to advanced precision diagnostics in breast cancer care that improve patient outcomes through new and innovative tools.”
Behind the PREDICT and HER2-Positive Trials
In June 2024, the prospective, multi-institutional PREDICT study (NCT03448926) identified the DCISionRT test as a key tool in shaping clinician decisions about radiotherapy for patients with DCIS patient population.2 The study showed that 38% of patients had their radiotherapy recommendations altered based on the test results, resulting in a 20% reduction in overall recommendations for radiation therapy (P <.001).3 Among those initially advised against radiation, 31% were later recommended to undergo the treatment.
Of those enrolled, the median age of patients was 62 years, 32% had grade 3 tumors, and 10% had tumors larger than 2.5 cm. The study’s primary end point was the frequency in the change in clinicians’ recommendations for radiation therapy from before the test to after the test.
“What the study shows is that the use of the DCISionRT 7-gene biosignature is the factor that has the most significant impact on decision making. It is key for patients working with their clinicians and having an informed discussion about the benefits of radiation therapy,” explained Chirag Shah, MD, radiation oncologist at Cleveland Clinic, codirector of the comprehensive breast cancer program, and director of breast radiation oncology, in an interview with Targeted OncologyTM.
Then in October 2024, another study showed that the DCISionRT test helped identify an increased risk of in-breast recurrence in patients with HER2-positive DCIS.4 Among the 178 patients with HER2-positive DCIS who underwent BCS with chemotherapy, 113 (63%) in the study had residual risk subtype disease, as identified by the DCISionRT test. A total of 28 were identified as having low-risk disease, and 37 were identified as having elevated-risk disease.5
For patients with the residual risk subtype, total in-breast recurrence risk was significantly higher when compared with all other subtypes (HR, 8.3; 95% CI, 1.1-50.0; P = .01).
The study included patients with HER2-positive DCIS who had received BCS plus radiotherapy were included in the study. Patients were required to have complete biomarker data and negative margins.
In this study, the primary end point was to test the hypothesis that patients with the reduced risk subtype would experience a higher in-breast recurrence risk compared with patients who do not have the reduced risk subtype.
REFERENCES:
PreludeDx receives FDA breakthrough device designation for DCISionRT® test for DCIS breast cancer patients. News release. PreludeDx. January 16, 2025. Accessed January 22, 2025. https://tinyurl.com/2u39a7bp
The DCISionRT® test result is the most important factor determining clinician treatment recommendations – findings from multicenter PREDICT study of 2,007 patients. News release. PreludeDx. June 26, 2024. Accessed January 22, 2025. https://tinyurl.com/yapepwr8
Shah C, Whitworth P, Vicini FA, et al. The clinical utility of a 7-gene biosignature on radiation therapy decision making in patients with ductal carcinoma in situ following breast-conserving surgery: an updated analysis of the DCISionRT® PREDICT study. Ann Surg Oncol. 2024;31(9):5919-5928. doi:10.1245/s10434-024-15566-5
PreludeDx announces groundbreaking study results on HER2-positive DCIS patients. News release. PreludeDx. October 2, 2024. Accessed January 22, 2025. https://tinyurl.com/6xrkb68b
Vicini F, Shah C, Mittal K, et al. A 7-gene biosignature for ductal carcinoma in situ of the breast identifies subpopulations of HER2-positive patients with distinct recurrence rates after breast-conserving surgery and radiation therapy. Clinical Breast Cancer. Published September 4, 2024. doi:10.1016/j.clbc.2024.08.016
