OraSure Technologies’ Subsidiary Diversigen Launches Metatranscriptomic Sequencing and Analysis Services for Gut Microbiome Samples

BETHLEHEM, Pa., March 31, 2022 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that its’ Diversigen subsidiary has launched a new service to provide metatranscriptomic sequencing and analysis of gut microbiome samples.

“This is an exciting service as metatranscriptomics helps researchers understand gene expression and gain insights regarding both function and mechanism,” said Kathleen Weber, President, Molecular Solutions for OraSure Technologies. “Changes in the function of the gut microbial community can be associated with disease onset and aging, as well as the effectiveness of interventions such as pharmaceuticals and diet. We strongly believe that better understanding these connections will help drive further understanding and innovation with our customers.”

The metatranscriptomic services will generate a microbial community’s gene expression profile to inform customers about the interactions between an individual and their microbiome and will provide a holistic picture of a sample’s microbial functions and expression levels. Diversigen’s team of scientists has optimized extraction methods to ensure successful recovery of microbial mRNA, evaluated and confirmed reproducible library preparation and sequencing approaches, and created a curated database with more than 190,000 genomes, representing 31,000 species of microbes, to allow profiling of gene expressions, pathways, and functional categories not possible with metagenomics or amplicon sequencing.

Researchers in the pharmaceutical, biotechnical, academic, and consumer products fields are the anticipated customers for these new services.

About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, 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.

About Diversigen
Diversigen, Inc. is a subsidiary of OraSure Technologies Inc. Diversigen and CoreBiome, Inc. (also an OraSure subsidiary), 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 and CAP 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.

Important Information
This press release contains certain forward-looking statements, including with respect to the Company’s products, product development activities, regulatory submissions and authorizations and other matters. 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: risk that the Company’s exploration of strategic alternatives may not result in any definitive transaction or enhance stockholder value and may create a distraction or uncertainty that may adversely affect operating results, business or investor perceptions; the diversion of management’s attention from the Company’s ongoing business and regular business responsibilities due to the Company’s exploration of strategic alternatives; ability to resolve the Company’s ongoing manufacturing challenges and satisfy customer demand; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; 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; the impact of the novel coronavirus (“COVID-19”) pandemic on the Company’s business and ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing; 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 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; impact of competitors, competing products and technology changes; reduction or deferral of public 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; impact of contracting with the U.S. government; impact of negative economic conditions; 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 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 our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2021, 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. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.