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NeuMoDx, SelfScreen Collaborate to Obtain CE Marking for HPV Assay

NEW YORK – Molecular diagnostics firm NeuMoDx will collaborate with SelfScreen, a Netherlands-based company, to commercialize a human papillomavirus screening test.

SelfScreen, a spinout of VU University Medical Center in Amsterdam, has developed a real-time PCR-based HPV screening test that detects 15 high-risk genotypes that can cause cervical cancer.

Under the agreement, SelfScreen will oversee the regulatory processes to obtain CE-IVD marking for the assay on the NeuMoDx 288 and NeuMoDx 96 sample-to-result systems, and NeuMoDx will manufacture and sell the assay.

The NeuMoDx systems are high-throughput, random-access molecular diagnostics platforms designed for use in hospital and reference labs. The firm's initial instrument clearance by the US Food and Drug Administration was in 2018 along with a test for group B streptococcus.

"This agreement represents the next step in our strategy to expand our systems' content menu by collaborating with key assay partners," Jeff Williams, chairman and CEO of NeuMoDx, said in a statement.

Qiagen is the exclusive distributor of the NeuMoDx 288 and NeuMoDx 96 Molecular Systems in Europe and other markets outside the US, while NeuMoDx covers the US directly. Qiagen also currently markets two CE-IVD tests originally created by SelfScreen — the QIAscreen HPV PCR Test and the QIAsure Methylation Test.

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, the statement further noted. The firms have previously described a plan to quickly build out menu on the NeuMoDx instruments.

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