The test predicts the radiation therapy benefits for the DCIS-diagnosed women. Credit: Olha Povozniuk / Shutterstock.

The US Food and Drug Administration (FDA) has granted breakthrough device designation to PreludeDx’s DCISionRT test, a risk assessment tool for ductal carcinoma in situ (DCIS), also known as Stage 0 breast cancer.

This test predicts the benefits of radiation therapy (RT) for women diagnosed with this condition.

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Designed for women aged between 30 and 85 who have undergone breast-conserving surgery (BCS) for DCIS, the test serves as a prognostic tool for the ten-year risk of breast cancer recurrence. It also identifies residual risk patients even after BCS and RT.

It claims to integrate tumour biology with clinical factors to provide individualised outcomes. By evaluating protein expression from seven biomarkers and four clinicopathologic factors leveraging a non-linear algorithm, DCISionRT interprets complex biological data to assist in making informed treatment decisions.

DCISionRT provides a ‘DecisionScore’ that categorises a woman’s risk levels as low, elevated, or residual. This underscores the test’s prediction of RT benefits, which could potentially reduce both over- and under-treatment.

The test’s technology was licensed from the University of California, San Francisco, and based on research initially funded by the National Cancer Institute.

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PreludeDx president and CEO Dan Forche said: “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.”

Every year, more than 60,000 females in the US are diagnosed with DCIS, which is characterised by malignant cells lining the breast’s milk ducts without invading surrounding tissue.

Founded in 2009, PreludeDx is a company specialising in breast cancer diagnostics.