PreludeDx, a provider of molecular diagnostics and precision medicine for early-stage breast cancer, announced that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the DCISionRT test, effective April 2023.

“Receiving ADLT status is a major milestone for PreludeDx and confirms the clinical value and unique nature of the DCISionRT test,” says Dan Forche, president and CEO of PreludeDx. “We are committed to working closely with CMS to ensure that patients and physicians have access to our test and the ability to improve patient outcomes and quality of life through more informed, personalized treatment decisions.”

Further reading: DCIS Test Identifies Patients in Need of Intensified Therapy

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, among other criteria, the company says. The announcement of the ADLT approval for DCISionRT confirms that the test meets the criteria established by CMS for laboratory tests under the Protecting Access to Medicare Act of 2014 (PAMA). The DCISionRT test can help predict radiation therapy benefits for women diagnosed with DCIS and this new information improves shared decision-making between patients and their treating physicians.

PreludeDx is the eighth company to receive Advanced Diagnostic Laboratory Test distinction, according to the company.

The DCISionRT test has been adopted by top academic cancer centers and community centers throughout the U.S. 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.