New CE-IVD assay for HPV

Oct. 18, 2019

NeuMoDx Molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, announced an agreement with Self-screen BV to implement a CE-IVD marked molecular diagnostic test 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. This agreement represents the next step in our strategy to expand our systems’ content menu by collaborating with key assay partners,” said Jeff Williams, Chairman and CEO of NeuMoDx.

The HPV assay developed by Self-screen is a real-time PCR-based test that detects 15 recognized high-risk genotypes of human papillomavirus DNA. Under the agreement, Self-screen will handle regulatory processes to obtain CE-IVD marking for the assay on the NeuMoDx systems, while NeuMoDx will manufacture and sell the assay.

QIAGEN, a leader in Sample to Insight solutions for molecular testing, 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 U.S., directly. Under a 2018 merger agreement, QIAGEN has the right to acquire the remaining 80 percent of NeuMoDx shares that it does not currently own until mid-2020.

Self-screen BV, a biotech spinoff company of VU University Medical Center in Amsterdam, the Netherlands, was founded in 2008 to advance the implementation of scientific discoveries in cancer screening. Self-screen’s main focus is cervical cancer screening and prevention. QIAGEN now markets two CE-IVD tests created by Self-screen, the QIAscreen HPV PCR Test for detection of high-risk HPV, and the QIAsure Methylation Test, a complementary test for use in differentiating patients’ risk of developing cervical cancer.

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