CDKN2A and neoplasm: While the Roche Tissue Diagnostics (RTD) CINtec p16 IHC assay has been approved (FDA Class II IVD device) as a surrogate marker for HPV in FFPE cervical biopsy samples on the BenchMark staining platform [23], there is no approved p16 IHC assay to determine HPV status in OPSCC tumor samples to date.