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NeuMoDx Molecular Announces CE Mark for HPV Diagnostic Test

Ann Arbor, MI (July 20, 2020) – NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, announced today it has received CE Mark approval for its molecular diagnostic test for high-risk types of human papillomavirus (HPV), which was developed in collaboration with Self-screen BV (Amsterdam, the Netherlands). HPV is the virus regarded as the major cause of cervical cancer.

The NeuMoDx™ HPV Assay, implemented on the NeuMoDx™ 96 and NeuMoDx™ 288 Molecular Systems is a fully automated, in vitro real-time PCR-based assay for the qualitative detection of high-risk types of HPV DNA in cervical specimens. The test specifically identifies HPV 16 and 18 while concurrently detecting the other 13 common high-risk types at clinically relevant infection levels. Overall performance related to clinical sensitivity, clinical specificity, and intra/inter- laboratory reproducibility is in conformance with accepted international guidelines for HPV test requirements, commonly known as the Meijer criteria, for primary cervical cancer screening.

Prof. Chris Meijer, CEO of Self-screen commented, “We are proud that the hrHPV assay as developed by Self-Screen is now implemented on the NeuMoDx platform which has the most advanced molecular technology today. In many regions cervical screening is converting from cytology towards HPV testing. As new HPV tests come to market it is critical that such tests are validated in well-defined clinical practice. 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 continues: “The fruitful collaboration between NeuMoDx and Self-screen, now offers cervical screening laboratories and organizations a new generation in automation of HPV testing”.

NeuMoDx Molecular offers solutions that integrate the entire molecular diagnostic process – from extraction to detection – with the first results available in as quickly as 60 minutes. These innovative analyzers provide operators with the ability to load patient samples in a continuous, random-access workflow resulting in on-demand, high throughput sample processing with a true operator walkaway window of up to eight hours. “We are pleased to augment our internal development efforts by collaborating with key partners such as Self-screen to continue expanding our menu.” said Sundu Brahmasandra, NeuMoDx President and COO. “Our efforts have resulted in a menu of over 14 CE Marked assays focused on respiratory illness, post-transplant monitoring, women’s health and blood borne viruses, with several additional tests expected by the end of 2020.”

Today’s clinical laboratories are challenged to increase productivity through process optimization and cost management. The proprietary NeuDry™ reagents used with the systems require no refrigeration and are extremely robust with an on-board stability of up to 60 days and ambient  temperature shelf life of greater than one year. The unitized format of the NeuDry reagents significantly increases operating efficiency while minimizing the waste leading to enhanced cost control.

About NeuMoDx

NeuMoDx Molecular designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. For more information visit www.neumodx.com.

About Self-screen

Self-screen B.V. designs, develops and validates tests for the detection, screening of (pre)cancer and monitoring of patients after (pre)cancer treatment. Self-screen’s experience and focus is in cervical (pre)cancers, followed by HPV-induced other cancers.

Coronavirus Assay Information

NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on providing testing solutions to hospital and commercial reference laboratories, has developed a SARS-CoV-2 Assay for use on the high throughput, fully automated NeuMoDx™ 288 and 96 Molecular Systems. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the NeuMoDx™ SARS-CoV-2 Assay implemented on the NeuMoDx™ Molecular Systems.

To learn more about SARS-CoV-2 testing, click here.
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