NeuMoDx Molecular, Ann Arbor, Mich, in conjunction with Self-Screen BV, Amsterdam, the Netherlands, has introduced a CE-marked molecular diagnostic for high-risk strains of human papillomavirus (HPV) on the NeuMoDx 288 and NeuMoDx 96 molecular systems. HPV is the virus regarded as the major cause of cervical cancer.
“Self-Screen is a leader in developing innovative molecular tests for the diagnosis of genital cancers, and adding this important women’s health assay to our fully automated continuous random-access NeuMoDx systems will help in the global battle to prevent cervical cancer,” says Jeff Williams, chairman and CEO of NeuMoDx. “This agreement represents the next step in our strategy to expand our systems’ content menu by collaborating with key assay partners.”
The HPV assay developed by Self-Screen is a real-time polymerase chain reaction-based test that detects 15 recognized high-risk genotypes of human papillomavirus DNA. Under the companies’ partnering agreement, Self-Screen will handle regulatory processes to obtain CE marking for the assay on the NeuMoDx systems, while NeuMoDx will manufacture and sell the assay.
Qiagen is the exclusive distributor of the NeuMoDx 288 and NeuMoDx 96 molecular systems in Europe and other major markets outside the United States, while NeuMoDx covers the United States directly. Under a 2018 agreement, Qiagen has the right to acquire the remaining 80% of NeuMoDx shares that it does not currently own until mid 2020.
HPV is the most common viral infection of the genital tract and the major cause of cervical cancer, the fourth most common cancer among women. The World Health Organization reported an estimated 570,000 new cases of cervical cancer and 311,000 deaths in 2018. Almost 300 million women globally are estimated to be infected with HPV, and about 30 million additional cases have progressed to the precancerous stage.
For more information visit NeuMoDx.