Full-molecular automated cervical screening is now possible combining the objectivity, reproducibility and high-throughput aspects of both the HPV-Risk Assay and the QIAsure Methylation Test.
The HPV-Risk Assay is an in vitro real-time PCR-based assay for the qualitative detection of human papillomavirus (HPV) DNA, targeting the E7 region of the following 15 (probably) high-risk HPV genotypes, i.e., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, and 68.
The automated workflow on the NeuMoDx™ 96 and 288 Molecular Systems include DNA extraction, PCR amplification, fluorescent detection and result calculation.
The analytical and clinical validations are performed according to the International “Meijer” HPV DNA Test Guidelines.
The QIAsure Methylation Test is a real-time PCR-based molecular assay to distinguish women with cervical (pre)cancer. The QIAsure Methylation Test specifically detects women with a cancer-like methylation profile that have a short term high risk for progression to cervical cancer.
Self-screen has developed the PreCursor-M AnoGYN Methylation Assay (RUO). This 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.
The methylation assay pipeline of Self-screen has now been extended with the Precursor-M Gold assay. The newly developed Precursor-M Gold assay is currently available for Research Use Only indications.
Precursor-M Gold demonstrates very good clinical performance in the detection of high grade precursor stadia and cervical cancer among HPV positive women. The assay is ready for further IVD validation on a platform or workflow of choice.
Self-screen is constantly developing novel state-of-the-art clinical tests for (early) cancer detection. These tests meet growing requirements in both primary screening as well as triage settings.
