TEST:

PreCursor-M AnoGYN Methylation Assay

PreCursor-M AnoGYN Methylation Assay identifies the hypermethylation levels of two genes, ASCL1 and ZNF582, respectively in anal specimens. With the ACTB reference gene, the PreCursor-M AnoGYN is developed as a multiplex quantitative methylation specific PCR on the RotorGeneQ (QIAGEN), Mic (Biomolecular Systems) and ViiA7 (ThermoFisher) cyclers. In a cross-sectional study on a series of anal biopsies, covering all stages of anal disease, the assay demonstrates a diagnostic performance of AIN3+ of 0.81. ASCL1 and ZNF582 methylation levels increased with increasing severity of disease.