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NeuMoDx Molecular Receives CE Mark for HPV Diagnostic Test

NEW YORK ─ NeuMoDx Molecular said on Monday that it has received the CE mark for a molecular diagnostic test for high-risk types of human papillomavirus, one of the main causes of cervical cancer.

The Ann Arbor, Michigan-based molecular diagnostics firm developed its NeuMoDx HPV Assay in collaboration with Amsterdam, the Netherlands-based 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, NeuMoDx said. "Overall performance related to clinical sensitivity, clinical specificity, and intra/inter-laboratory reproducibility is in conformance with accepted international guidelines for HPV test requirements … for primary cervical cancer screening," NeuMoDx said.

"The new NeuMoDx HPV 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," Chris Meijer, CEO of Self-screen, said in a statement.

NeuMoDx Molecular said it provides products that integrate all steps in the molecular diagnostic process, from extraction to detection, with the first results available in 60 minutes.

Its analyzers enable 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, NeuMoDx said. 

Sundu Brahmasandra, president and COO of NeuMoDx, noted that the firm's efforts to date have led to a menu of more than 14 CE-marked assays for respiratory illness, post-transplant monitoring, women’s health, and blood-borne viruses, with additional tests expected by the end of 2020.

In June, the company announced it had received CE marking for its HIV viral load test.