Publication date: 04/04/2019
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.
Novosanis, a wholly-owned subsidiary of OraSure Technologies, Inc., is an innovative developer and producer of medical devices adding value to the accuracy of diagnostics tests as well as drug delivery in the field of prevention, detection and treatment of infectious diseases and oncology.
Novosanis is a Belgian company endorsed on multiple occasions nationally and internationally for its solutions and is ISO13485 certified.
Novosanis focusses on user-friendly and innovative medical devices meeting all regulatory and quality requirements for self-sampling and drug delivery solutions that improve accuracy and standardization while making handling easier, more consistent and more comfortable for the user.
The company has two device platforms in its portfolio:
Colli-Pee® is a patented sampling device suited for volumetric collection of first-void urine (first 20ml of the urine flow) allowing improved detection of infectious diseases as well as early stage cancer. Colli-Pee™ is CE-marked and FDA listed.
VAX-ID® is a patented platform of injection devices suited for accurate drug delivery of e.g. therapeutic, prophylactic and allergy vaccines in the dermal layer of the skin. The devices are currently research use only (RUO).
For more information, please visit: www.novosanis.com
Fujirebio is a global leader in the field of high quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.
Founded in 1950 in Tokyo, Japan, Fujirebio has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Examples include Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010 (now: Fujirebio Europe). Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network. Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.
Fujirebio is today a member of Miraca Group (Miraca Holdings Inc. listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1.200 people in Asia, Europe and America.
For more information about Fujirebio please visit www.fujirebio.com.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture and distribution of point-of-care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians’ offices, commercial and industrial entities and consumers. The Company’s products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.