OraSure Technologies Addresses FDA Warning Letter Received by Its Subsidiary DNA Genotek
07 Gennaio 2014 - 3:52PM
OraSure Technologies, Inc. (Nasdaq:OSUR) announced that its
molecular collection systems subsidiary, DNA Genotek, received a
warning letter from the U.S. Food and Drug Administration (FDA)
which the FDA posted today on its website. The warning letter
primarily focuses on DNA Genotek's response to two observations
issued by the FDA on Form 483 as a result of a routine inspection
of DNA Genotek's Ottawa, Canada facilities in September 2013.
DNA Genotek is actively engaged and working with the FDA to
address the agency's observations and will continue to sell and
market all of its products while responding to the warning letter.
No material impact to product sales or OraSure's consolidated
financial performance is expected as a result of the issues raised
by the warning letter.
The warning letter requests additional documentation related to
finished product acceptance testing activities for DNA Genotek's
ORAcollect OC-100 collection device, a swab-like product with a
small customer base that accounted for approximately one-half of
one percent of OraSure's consolidated revenues in 2013. The letter
notes that DNA Genotek does not currently have in place an approved
premarket approval application or 510(k) clearance for its
ORAcollect OC-100 device.
In addition, the warning letter indicates the need for
additional documentation regarding design and development
activities for DNA Genotek's products and focuses in particular on
the design planning and design history file for its 510(k) cleared
OrageneDx collection device, a product primarily used in commercial
applications. A product similar to OrageneDx, sold under the
name OrageneDiscover, is used primarily for research applications
and was not specifically addressed by the warning letter.
A copy of the warning letter can be found on the FDA's website
at
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm379997.htm.
"We take this letter from the FDA very seriously and we are
working closely with the agency to ensure we fully address their
concerns and observations," said Douglas A. Michels, President and
CEO of OraSure Technologies. "We are committed to providing
the highest quality products to our customers and to continuously
enhancing our systems and processes."
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture
and distribution of oral fluid diagnostic and collection devices
and other technologies designed to detect or diagnose critical
medical conditions. Its innovative products include rapid tests for
the detection of antibodies to HIV and HCV at the point of care and
testing solutions for detecting various drugs of abuse. In July
2012, the Company received approval from the U.S. Food and Drug
Administration for the Company's OraQuick® In-Home HIV Test for
sale directly to consumers in the over-the-counter (OTC) market -
making it the first and only rapid OTC HIV test approved in the
U.S. In addition, the Company is a leading provider of oral fluid
sample collection, stabilization and preparation products for
molecular diagnostic applications. 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, and commercial and
industrial entities. The Company's products enable healthcare
providers to deliver critical information to patients, empowering
them to make decisions to improve and protect their health.
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 product sales and availability and
financial performance. 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 market and
sell products, whether through an 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
483 observations, warning letters and other findings or
communications from the FDA and 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; failure of distributors or other customers to meet
purchase forecasts or minimum purchase requirements for the
Company's products; impact of replacing distributors; inventory
levels at distributors and other customers; ability to integrate
and realize the full benefits of the Company's acquisition of DNA
Genotek; ability of DNA Genotek to achieve its financial and
strategic objectives; ability to identify, complete, integrate and
realize the full benefits of future acquisitions; impact of
competitors, competing products and technology changes; impact of
the economic downturn, high unemployment and poor credit
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, including the OraQuick® In-Home HIV test; market
acceptance of oral fluid testing or other products; changes in
market acceptance of products based on product performance,
extended shelf life or other factors; 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; history of
losses and ability to achieve sustained profitability; ability to
utilize net operating loss carry forwards or other deferred tax
assets; volatility of our 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 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 are discussed more fully in the Company's
Securities and Exchange Commission filings, including its
registration statements, Annual Report on Form 10-K for the year
ended December 31, 2012, 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.
CONTACT: Investor Contact:
Ron Spair
OraSure Technologies
610-882-1820
investorinfo@orasure.com
Media Contact:
Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
917-748-4006
jmoritz@0to5.com
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