July 2020, NeuMoDx Molecular has received the CE mark for a molecular diagnostic test for high-risk types of human papillomavirus.
The assay is developed in collaboration with Self-screen.
NeuMoDx HPV is a fully automated real-time PCR assay for the qualitative detection of high-risk types of HPV DNA in cervical specimens, which runs on the NeuMoDx 96 and NeuMoDx 288 molecular systems. The test identifies HPV 16 and 18 and concurrently detects the other 13 common high-risk types at clinically relevant levels of HPV infection “Overall performance related to clinical sensitivity, clinical specificity, and intra/inter-laboratory reproducibility is in conformance with the international guidelines for HPV test requirements for primary cervical cancer screening.
The assay provides products that integrate all steps in the molecular diagnostic process, from extraction to detection, with the first results available in 60 minutes and it enables operators to load patient samples in a continuous, random-access workflow, resulting in on-demand, high-throughput sample processing with an operator walkaway time of up to eight hours. NeuDry reagents used with its systems require no refrigeration, have on-board stability of up to 60 days, and have ambient temperature shelf life of greater than one year.
The assay fully meets the requirements of an HPV test with a screening purpose, because of its demonstrated excellent clinical sensitivity and specificity for the identification of women at risk of cervical cancer and precancerous cervical lesions.