PreludeDx's DCISionRT Test Receives ADLT Status Approval From Centers for Medicare & Medicaid Services

Prelude Corporation, a pioneer in molecular diagnostics and precision medicine for early-stage breast cancer, announced that the DCISionRT test has been granted Advanced Diagnostic Laboratory Test (ADLT) status by the Centers for Medicare & Medicaid Services (CMS) effective April 1, 2023. Being granted ADLT status is a significant milestone for PreludeDx, confirming the clinical value and unique nature of the DCISionRT test," says Dan Forche, president and CEO of PreludeDx.

"We are committed to collaborating closely with CMS to ensure that patients and physicians have access to our test and that we can improve patient outcomes and quality of life through more informed, personalised treatment decisions." Among other criteria, ADLT status is reserved for innovative products with Medicare coverage that provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests.

The announcement of the ADLT approval for DCISionRT confirms that the test meets the CMS laboratory test criteria established under the Protecting Access to Medicare Act of 2014. (PAMA). The DCISionRT test is the only one that can predict radiation therapy benefit for women diagnosed with DCIS, and this new information improves patient-physician collaboration. PreludeDx is only the eighth company to be recognised for Advanced Diagnostic Laboratory Test. The DCISionRT test has been adopted by top academic cancer centers and community centers through the US and world-wide to help guide personalized treatment for women diagnosed with DCIS.

The test has been clinically validated with peer-reviewed publications on independent, randomized, and prospective studies in over 4,000 patients. DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with riskbased assessment scores to assess a woman’s individual tumour biology along with other pathologic risk factors and provide a personalized recurrence risk.

The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

PreludeDx is a leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient’s treatment decision.