OraSure Technologies Receives General Clearance for its ORAcollect®•Dx Device for Over-the Counter (OTC) Use from the U.S. Food and Drug Administration (FDA)
03 Novembre 2022 - 2:15PM
OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in
point-of-care and home diagnostic testing and sample collection
technologies, announced today that the Company received U.S. FDA
clearance for its ORAcollect®•Dx saliva collection device for OTC
(i.e. direct-to-consumer) use. The device had been previously
cleared for prescription use by the FDA. ORAcollect®•Dx joins the
Oragene®•Dx product line which previously received FDA general
clearance for prescription and OTC use. This new designation now
allows ORAcollect®•Dx devices to be used by OraSure’s commercial
partners and legally marketed with their therapeutics or devices in
conjunction with their product’s intended use. Both the
ORAcollect®•Dx, and Oragene®•Dx devices are designed to be used by
an adult at home, without direction from a healthcare professional.
OraSure received this designation through its
partnership with Grifols to support screening for
alpha1-antitrypsin deficiency (alpha-1) in individuals who may be
at risk for alpha-1. Alpha-1 raises patients’ risks for lung
disorders and it is estimated that about 3% of COPD patients have
alpha-1. Beginning in Q2 2023, Grifols will offer free AlphaID™ At
Home Genetic Health Risk Service, supporting alpha-1 screening,
that utilize the ORAcollect®•Dx device to help identify individuals
at risk. According to the Centers for Disease Control, COPD affects
over 15 million people in the United States.
“This clearance represents a major milestone for
OraSure as we work in conjunction with our commercial partners to
increase access to healthcare,” said Kathleen Weber, President of
Molecular Solutions for OraSure Technologies. “With the movement
toward precision medicine, we increasingly see the need for genetic
testing supporting FDA approved therapeutics as drugs become more
specialized for targeted patient populations. This expanded
designation now allows us to better support our customers and
expands the potential for future indications with the
ORAcollect®•Dx device.”
“We look forward to working with an experienced
partner such as OraSure to expand access to alpha-1 testing and
awareness,” said Antonio Martínez, President, Grifols
Diagnostic.
About DNA GenotekDNA Genotek Inc., a
subsidiary of OraSure Technologies, Inc., focuses on providing
high-quality biological sample collection products and end-to-end
services for human genomics and microbiome applications. The
Company's Oragene®•Dx and ORAcollect®•Dx product lines are the
first and only FDA 510(k) cleared saliva-based DNA collection
devices for in vitro diagnostic use. DNA Genotek also
offers Research Use Only products to collect and preserve large
amounts of DNA or RNA from multiple sample types. DNA
Genotek markets its products worldwide and has a global
customer base with thousands of customers in over 100 countries.
For more information about DNA Genotek,
visit www.dnagenotek.com.
About OraSure
TechnologiesOraSure 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.
Important InformationThis 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.
Investor
Contact: |
Media
Contact: |
Scott Gleason |
Amy Koch |
SVP Investor Relations & Corporate Communications |
Sr. Mgr. Corporate Communications |
484-425-0588 |
484-523-1815 |
sgleason@orasure.com |
media@orasure.com |
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