Healthcare Industry News:  Papillomavirus 

Diagnostics Regulatory Product Launch

 News Release - October 19, 2016

GeneFirst Announces CE Marking and Release of Papilloplex(R) HR-HPV, a PCR Based Molecular Diagnostic Test for Genotyping 14 High Risk Human Papillomaviruses from Cervical and Urine Samples

OXFORD, England, October 19, 2016 -- (Healthcare Sales & Marketing Network) -- GeneFirst Ltd today announced the release of Papilloplex® HR-HPV to be marketed as a CE-IVD product under the European Directive on In Vitro Diagnostic Medical Devices.

Direct link between persistent HR-HPV infection and progression to cervical cancer has created major diagnostic opportunities. Accurate molecular detection of HR-HPV genotype is of great use for cervical screening programmes, monitoring treatment and epidemiological studies. Popular genotyping methods uses either hybridization or multi-tube PCR. Papilloplex® HR-HPV Genotyping Kit can detect and differentiate all 14 HR-HPV types together with a cellular control target in a single closed tube real-time PCR.

"Launching the first product based on our patented MPA technology is a significant milestone for GeneFirst, and aligns with the company's strategic focus to drive forward new product development in the areas of oncology and infectious diseases" commented Guoliang Fu, GeneFirst's CEO. Multiplex Probe Amplification (MPA) technology allows differentiation of up to six targets per fluorescence channel using target specific PCR primers and probes.

"Papilloplex provides an important improvement over most existing restricted- or limited-genotyping commercial assays which do not detect all HR-HPV types or, even worse, tests that fail to discriminate among HPV types," commented Professor Clementina Cocuzza, of the Department of Medicine and Surgery, University of Milan-Bicocca, Italy. "The use of accurate full-genotyping tests allows to distinguish persistent HPV infections associated with an increased risk of cervical cancer progression, from common transient HPV infections".

The kit is suitable for use with not only cervical swabs (liquid-based cytology) but also on first-void urine samples. Urine samples are now gaining popularity for cervical screening programs due to their potential increased uptake rate. "It's been a pleasure collaborating with GeneFirst on detection of HR-HPV using standardized first-void urine samples obtained with the Colli-Pee device. Papilloplex will be the first CE-marked kit for HR-HPV that includes first-void urine as a sample type. Colli-Pee's ease of use fits perfect in the overall strategy of Papilloplex HR-HPV. Looking forward to future collaborations." says Vanessa Vankerckhoven, CEO Novosanis, Belgium.

About GeneFirst

GeneFirst Ltd is a molecular diagnostics company working predominantly in the fields of infectious diseases, cancer diagnostics and personalized medicine. GeneFirst offers robust easy-to-use, sensitive, and affordable molecular diagnostics technologies and products. For more information, visit or contact

Source: GeneFirst

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