PreludeDx's DCISionRT Test Hits 45,000-Patient Milestone, Gains FDA…

Event summary

PreludeDx's DCISionRT test has been ordered by 3,000 physicians for 45,000 patients, with 1/3 of US DCIS patients undergoing breast-conserving surgery now using it.
The PREDICT study showed DCISionRT changed radiation therapy recommendations in 38% of 2,007 cases across 63 centers.
DCISionRT received FDA Breakthrough Device designation and CMS ADLT status in 2026.
Over 50% of low-risk patients by clinical-pathologic criteria were reclassified as high-risk by DCISionRT, benefiting from radiation therapy.

The big picture

PreludeDx's DCISionRT is becoming a standard tool in personalized breast cancer treatment, with regulatory endorsements and clinical evidence supporting its role in reducing overtreatment. The test's growing adoption reflects a broader industry shift toward biologically informed, precision oncology approaches. With 60,000 new DCIS cases annually in the US, the market potential for such diagnostic tools is substantial.

What we're watching

Adoption Pace: Whether DCISionRT can maintain its exponential growth rate in physician adoption and patient utilization.
Clinical Impact: How the test's ability to reclassify patient risk will affect long-term treatment outcomes and healthcare costs.
Regulatory Tailwinds: The potential for additional regulatory recognitions to further solidify DCISionRT's position in personalized breast cancer care.