Molecular diagnostics company Prelude Corporation reported on Wednesday the receipt of approval from the State of New York Clinical Laboratory Evaluation Programme (CLEP) for the proprietary DCISionRT test for patients diagnosed with ductal carcinoma in situ (DCIS), the most common type of non-invasive breast cancer.
The company said DCISionRT is the only DCIS test that assesses recurrence risk and can predict radiation therapy benefit, a critical decision point in DCIS. DCISionRT assesses a woman's individual tumour biology and other risk factors to provide a personalised Decision Score that identifies a woman's risk as low or elevated.
Established by the New York State Department of Health (NYSDOH), CLEP ensures the accuracy and reliability of tests performed for residents of New York. The programme has meticulous evaluation standards and requires on-site inspections.
According to the company, DCISionRT test is available in all 50 US states.
Prior to this approval, DCISionRT was available in New York through a waiver programme requiring a restricted permit be issued on a patient-by-patient basis from CLEP. The PreludeDx laboratory is accredited by the College of American Pathology (CAP) and has CLIA certification.
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