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GeneFirst releases PCR based molecular diagnostic test

Published 20 October 2016

GeneFirst has launched Papilloplex HR-HPV, a PCR based molecular diagnostic test for genotyping 14 high risk human papillomaviruses from cervical and urine samples.

The company said major diagnostic opportunities have been created due to direct link between persistent HR-HPV infection and progression to cervical cancer.

Accurate molecular detection of HR-HPV genotype can be important in cervical screening programmes, monitoring treatment and epidemiological studies.

Several genotyping methods in the market use either hybridisation or multi-tube PCR. GeneFirst claims that its Papilloplex HR-HPV Genotyping kit can detect and differentiate all the 14 HR-HPV types together with a cellular control target in a closed tube real-time PCR.

GeneFirst CEO Guoliang Fu said: "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.”

The kit can be used not only with cervical swabs (liquid-based cytology), but also on first-void urine samples. The use of urine samples in cervical screening process has increased in the recent times due their potential uptake rate.

University of Milan-Bicocca Department of Medicine and Surgery Professor Clementina Cocuzza said: "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.

"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."