FDA Grants Breakthrough Device Designation to DCISionRT for Breast Cancer With DCIS

The FDA has granted a breakthrough device designation to the DCISionRT test for patients with breast cancer with ductal carcinoma in situ (DCIS), according to an announcement from PreludeDX.1

DCISionRT assesses individual recurrence risk after breast-conserving surgery alone and with the addition of radiotherapy in women diagnosed with breast cancer with DCIS—also described as stage 0 breast cancer. The test also predicts radiation therapy benefit. The test analyzes 4 clinical factors and 7 protein biomarkers to produce a DecisionScore that identifies a patient’s recurrence risk as low, elevated, or residual, and the test is intended to help oncologists determine patients who are most likely to benefit from radiotherapy after breast-conserving surgery, which can help reduce under- and over-treatment. The test employs a nonlinear algorithm to consider multiple interactions between individual factors.

“DCISionRT addresses an unmet need for [patients with] DCIS by answering the questions: ‘Do I need radiation therapy?’ and ‘Will I benefit?’” Dan Forche, president and chief executive officer of PreludeDx, stated in a news release. “DCISionRT helps patients and their physicians to make a better and more informed treatment decision.”

DCISionRT is designed for use in women 30 to 85 years of age. The test is prognostic for 10-year risk of breast cancer recurrence and can identify patients who have residual risk after undergoing breast-conserving surgery and receiving radiation therapy.

Notably, the observational, prospective PREDICT study (NCT03448926), findings from which were published in the Annals of Surgical Oncology in June 2024, investigated the clinical utility of DCISionRT and its effect on radiotherapy recommendations for patients with DCIS.2,3 Between February 2018 and January 2022, 2496 patients were enrolled.3 The study reported findings from 2007 eligible women with DCIS across 63 centers in the United States who were offered the DCISionRT test as part of their standard of care.2,3 Oncologist treatment recommendations were reported before and after receiving the DCISionRT test results.

Patients needed to be at least 25 years of age, have a diagnosis of DCIS, and be considering breast-conserving treatment.3

The primary end point was the percentage of patients in whom DCISionRT testing led to a change in radiotherapy recommendation. The effect of the DCISionRT test results on treatment recommendations was evaluated in patient subsets defined by pathologic features and clinical factors; patients were also evaluated following clinicopathologic criteria for “low risk.”

The study showed that DCISionRT test results led to changes in pre-test to post-test radiotherapy recommendations in 38% of patients.2,3 DCISionRT results contributed to a 20% net reduction in the number of patients who were recommended for radiotherapy pre-test (71%) vs post-test (51%; P < .001). The test also showed that 41% of the patients who were recommended for radiotherapy pre-test had a change in recommendation to not receive radiotherapy post-test, and 31% of the patients who were not recommended for radiotherapy pre-test were subsequently recommended for this treatment based on DCISionRT results.

The rates of post-test radiotherapy recommendations increased with increasing DecisionScore, from 29% (DecisionScore < 2) to 66% (DecisionScore 2-4) to 91% (DecisionScore > 4).3 Furthermore, the DCISionRT DecisionScore was found to be the strongest predictor of post-test radiotherapy recommendation compared with traditional clinicopathologic factors, including tumor grade and size (odds ratio for DecisionScore > 3 vs ≤ 3, 22.2; 95% CI, 16.3-30.7).

“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,” Forche concluded in the news release.1

References

1. PreludeDx receives FDA breakthrough device designation for DCISionRT test for DCIS breast cancer patients. News release. PreludeDX. January 16, 2025. Accessed January 20, 2025. https://preludedx.com/wp-content/uploads/2025/01/PRDX-SocM-105-FDA-Press-Release-FINAL.pdf
2. 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 20, 2025. https://preludedx.com/wp-content/uploads/2024/06/ASO-Press-Release-6-26-24.pdf
3. 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