NEW YORK (GenomeWeb) – PreludeDx said today that the State of New York Clinical Laboratory Evaluation Program (CLEP) has approved its DCISionRT test, which assesses recurrence risk and can predict radiation therapy benefit in patients diagnosed with non-invasive breast cancers known as ductal carcinoma in situ (DCIS).
PreludeDx's laboratory is also accredited by the College of American Pathology and has CLIA certification, so with CLEP approval, DCISionRT is now available in all 50 US states, the company said.
The assay uses a non-linear algorithmic approach that combines clinical and molecular pathway information. Scientific presentations describe the method as including HER2, PR, Ki67, COX2, p16/INK4A, FOXA1 and SIAH2 biomarkers.
According to Prelude, DCISionRT was developed and validated in studies that included over 2,000 women and can predict both 10-year local recurrence risk and radiation therapy benefit — something that was demonstrated in an analysis in the cohort of the SweDCIS randomized clinical trial.
The company also lists a study led by Kaiser Permanent Northwest, which it says confirmed that patients with an elevated test result have over a 70 percent risk reduction from radiation therapy.