OraSure Technologies Announces Support for New Federal Oral Fluid Drug Testing Guidelines
October 28 2019 - 5:00AM
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 Cuca |
Jeanne Mell |
Chief Financial Officer |
VP Corporate Communications |
610-882-1820 |
484-353-1575 |
Investorinfo@orasure.com |
media@orasure.com |
www.orasure.com |
www.orasure.com |
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