OraSure Technologies Announces Support for New Federal Oral Fluid Drug Testing Guidelines


BETHLEHEM, Pa., Oct. 28, 2019 (GLOBE NEWSWIRE) -- The Substance Abuse and Mental Health Services Administration (SAMHSA) has published new guidelines, permitting oral fluid drug testing in federally regulated markets. SAMHSA is the agency within the U.S. Department of Health and Human Services focused on reducing the impact of substance abuse and mental illness within America’s communities.

The newly endorsed use of oral fluid testing enables better detection of recent drug usage as it can differentiate between recent (last hour) drug use and historic (last weekend) drug use to effectively determine potential impairment on the job. Oral fluid testing also makes it easier, less costly and more efficient to collect a reliable sample over urine based testing.  The new SAMHSA guidelines will permit oral fluid drug testing in federally-regulated workplace settings and in other markets that follow the federal guidelines, none of which are being currently served by OraSure.

“Given the increased legalization of marijuana, whether for recreational or medicinal purposes, along with an opioid epidemic that is rampant in many cities and towns, workplace drug testing is more important than ever to support safe work environments and overall employee health and wellbeing. As a result, it is critical for employers to implement effective testing methodologies and decrease workplace risks,” says OraSure President and CEO Stephen S. Tang, Ph.D.

“As a leader in oral fluid substance abuse testing products, OraSure Technologies commends SAMHSA on updating its guidelines and recognizing the benefits of oral fluid testing,” Tang continues. “Our team of scientists pioneered oral fluid testing nearly 20 years ago. Our technology provides accurate and easy-to-administer testing methods to help determine the presence, or absence, of drugs or alcohol in a person’s system.”

OraSure will host informative webinars throughout 2020 to educate interested parties on the updated guidelines as well as the science and benefit of switching to oral fluid testing. OraSure will also provide the employer market with proven testing technologies that are backed by rigorous scientific review.           

About OraSure Technologies

OraSure Technologies is empowering the global community to improve health and wellness by providing access to accurate, essential information.  OraSure is a leader in the development, manufacture and distribution of point-of-care diagnostic tests, molecular 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 Hepatitis C (HCV) on the OraQuick® platform, sample self-collection and stabilization products for molecular applications, and oral fluid laboratory tests for detecting various drugs of abuse. Together with its wholly-owned subsidiaries (DNA Genotek, CoreBiome and Novosanis), OraSure provides its customers with value-added, end-to-end solutions that encompass tools, diagnostics and services.  OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research institutions, distributors, government agencies, physicians’ offices, commercial and industrial entities and consumers. For more information on OraSure Technologies, please visit www.orasure.com.

Important Information
This press release contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. 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: successfully managing and integrating acquisitions of other companies 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; the expected economic benefits of 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 and 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 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 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, 2018, 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.

Investor Contact:Media Contact:
Roberto CucaJeanne Mell
Chief Financial OfficerVP Corporate Communications
610-882-1820484-353-1575
Investorinfo@orasure.commedia@orasure.com
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