Diversigen, Inc. and Alimentiv Inc. Announce Collaboration Agreement for Ulcerative Colitis Research Study

ST. PAUL, MN, June 25, 2020 – Diversigen, Inc., a subsidiary of OraSure Technologies Inc. (NASDAQ:OSUR), and Alimentiv Inc. (formerly Robarts Clinical Trials) today announced they have signed a collaboration agreement for a research study on patients with Acute Severe Ulcerative Colitis (ASUC).

The study, titled: “Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis (PROTOS Study),” is designed to provide new insights into the molecular determinants of response to infliximab (IFX) in patients with ASUC. Under the terms of the agreement, the companies will co-fund the study. ASUC is the most aggressive presentation of ulcerative colitis (UC), and occurs in 15 percent of adults and children with UC. Thirty patients with ASUC who are starting infliximab in an acute setting will be recruited for the study.

The results will be jointly owned by Diversigen and Alimentiv, and the data will be co-published upon completion of the study.

“This is an exciting collaboration whereby we can apply our full gamut of precision medicine tools to better understand the molecular factors influencing drug response, which may provide the potential to address an unmet medical need in patients with ASUC,” said Dr. Niels Vande Casteele, Director, Precision Medicine, Alimentiv Inc. and Assistant Professor of Medicine, University of California San Diego. “We believe that Diversigen is the best partner for this precision medicine study given their outstanding track record of studying the microbiome in clinical trials. Our team is thrilled about the prospect of working with such a successful partner.

“Alimentiv is recognized for their expertise in inflammatory bowel disease (IBD) and clinical trial design and are at the forefront of accelerating gastro-intestinal (GI) drug development with precision medicine,” said Joy Nassif, Vice President, Services at Diversigen Inc. “We are proud that they are utilizing Diversigen’s science-driven, high-quality CLIA-customized solutions for metagenomics sequencing, bioinformatics, and statistical analysis for the study of the microbiome and look forward to deriving new insights that could lead to improvements in the treatment of patients with ASUC.”

Together Diversigen and Alimentiv will deliver end-to-end support for this precision medicine study. Alimentiv will leverage Diversigen’s expertise in metagenomic sequencing and analysis of the cohort samples. As overall study sponsor, Alimentiv will provide full service clinical study management, imaging and precision medicine services.

About Alimentiv Inc. [formerly Robarts Clinical Trials]

Alimentiv is a global research organization providing clinical trial, central image management and precision medicine services to the pharmaceutical and biotechnology industries. Headquartered in London Ontario, Canada, Alimentiv employs more than 300 people across its operations in Canada, the United States, Europe, and Latin America.  Its unique model combines the efforts of leading, internationally recognized academic researchers with operational experts to offer integrated solutions to its customers.   Founded in 1986 at the Robarts Research Institute, the clinical trials division was initially led by Dr. Henry Barnett.  In 1997, Dr. Brian Feagan, Professor of Medicine, Epidemiology & Biostatistics at Western University assumed leadership and built upon the foundation of academic excellence by focusing the organization on Inflammatory Bowel Disease (IBD) research.  Over the past 20 years, Alimentiv has become recognized as an expert in clinical trial design, central image management solutions, outcome measure development, and precision medicine for drug development in IBD.  Today, Alimentiv provides services in over 60 countries worldwide, collaborates with leading academic research institutions across the globe, and partners with many of the leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients with GI disease.

About Diversigen Inc.

Diversigen, Inc. is a subsidiary of OraSure Technologies Inc. Diversigen and another OraSure subsidiary, CoreBiome, Inc., came together to create one company under the Diversigen brand that is powering microbiome discovery through sequencing, analysis, and consulting services geared toward the study of the microbiome of living organisms and environments. Diversigen provides consultative end-to-end solutions for sequencing, bioinformatics, and statistical analysis for the study of the microbiome of living organisms and environments. Diversigen, Inc. operates a state-of-the-art CLIA accredited laboratory deploying a variety of techniques to extract high quality nucleic acids from a multitude of sample types for subsequent metagenomics analysis. Diversigen’s flexible sequencing and computing capacity, combined with ongoing improvements in analytic tools and their applications, allows for customized project-specific strategies. For more information, visit www.diversigen.com or contact info@diversigen.com.

About OraSure Technologies

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly owned subsidiaries, DNA Genotek, Diversigen, Core Biome (now operating under the Diversigen brand) and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

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