Novosanis enters into distribution deal with Fujirebio

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.[1] 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.[2]

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.

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For more information, please contact:

Vanessa Vankerckhoven, CEO Novosanis

+32486761885; press@novosanis.com; https://www.linkedin.com/in/vanessavankerckhoven/

US Contact:

Jeanne Mell, VP Corporate Communications, OraSure Technologies, Inc.

484-353-1575; media@orasure.com

About Novosanis

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

About Fujirebio

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.

Important Information

This press release contains certain forward-looking statements. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to successfully manage and integrate the acquisitions in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management's attention from our ongoing business and regular business responsibilities to effect such integration; failure to realize the expected economic benefits of the acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected or that our actual integration costs may exceed our estimates; ability to market and sell products, whether through our internal, direct sales force or third parties; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration (“FDA”) or other regulators; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company’s products; impact of significant customer concentration in the genomics business; impact of increased reliance on U.S. government contracts; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; impact of negative economic conditions; reduction or deferral of public or other funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (“CDC”) or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to meet financial covenants in credit agreements; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors that could affect our results are discussed more fully in the Company’s Securities and Exchange Commission (“SEC”) filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2017, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

[1] Evaluation of the INNO-LiPA HPV Genotyping Extra II on UCM preserved first-void urine. Poster Eurogin 2018 P10-5

[2] 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.