Novosanis enters into distribution deal with Fujirebio
Wijnegem, Belgium, April 4, 2019: Novosanis NV, a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), announced today that it has signed a worldwide, non-exclusive agreement with Fujirebio, a global leader in the field of in vitro diagnostics (IVD), for the distribution of Novosanis’ Colli-Pee® urine collection device for use with Fujirebio’s INNO-LiPA HPV genotyping Extra II assay. This agreement enables the detection and full genotyping of Human Papillomavirus (HPV) in first-void urine samples collected with the Novosanis device.
Recent feasibility studies with INNO-LiPA®, a highly sensitive method, which simultaneously identifies up to 32 HPV-genotypes, show promising results on self-collected urine samples. Use of a volumetric and standardized urine collection method such as Colli-Pee that captures first-void urine (first 20ml of urine flow) will help ensure more accurate detection with the INNO-LiPA assay. This is because first void urine has been shown to contain higher amounts of HPV DNA compared to random or midstream urine samples.
Vanessa Vankerckhoven, CEO of Novosanis, says “We are thrilled with our agreement with Fujirebio. Using Colli-Pee in combination with INNO-LiPA offers new opportunities in the field of HPV diagnostics. In light of the recent acquisition of Novosanis by OraSure Technologies, Inc., this new agreement will further allow us to expand the use of the Colli-Pee device internationally.”
“We’re excited to kick-off our collaboration with Novosanis. Self-collected urine samples are expected to become part of screening, post-vaccination monitoring and epidemiological programs. Analysis of Colli-Pee collected samples will be launched initially as a research use only (“RUO”) application, but CE-IVD products, in addition to other international registrations are expected soon,” explains Christiaan De Wilde, CEO of Fujirebio Europe.
 Evaluation of the INNO-LiPA HPV Genotyping Extra II on UCM preserved first-void urine. Poster Eurogin 2018 P10-5
 Optimization of HPV DNA detection in urine by improving collection, storage, and extraction. Vorsters A. et al. 2014a. Eur J Clin Microbiol Infect Dis 33 (11) 2005-2014.
Jeanne Mell, VP Corporate Communications, OraSure Technologies, Inc.