OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in
point-of-care and at-home diagnostic testing, as well as
non-invasive self-sampling technologies and microbiome-focused
biocomputational solutions, announced today that a major health
economics study featuring its Colli-Pee® device has been published
in the biomedical journal “BMJ Open.” This study, conducted by
experts from Aquarius Population Health Limited in London and the
University of Manchester, presents valuable insights into the
cost-effectiveness of self-sampling for routine human
papillomavirus (HPV) primary cervical cancer screening using the
Colli-Pee® UCM® self-collection device.
The study's noteworthy findings suggest that
self-sampling with the Colli-Pee® device could offer a more
affordable alternative to clinician-collected sampling and other
self-sampling methods. This has the potential to significantly
expand access to cervical cancer screening for underserved and
rural populations on a larger scale.
The health-economic research employed an
innovative cost-benefit analysis model, utilizing real-world
evidence from England’s primary HPV NHS Cervical Screening
Programme (NHSCSP). The study compared three sampling approaches
using a deterministic decision-tree model. The biocomputational
analysis simulated a cohort of 10,000 individuals representative of
the 400,000 people with a cervix aged 25 to 64 in England’s NHSCSP
during 2020 and 2021. The three sampling strategies evaluated were
routine clinician-collected cervical sample (identified as the most
expensive option), self-collected first-void urine via the
Colli-Pee® device (the least expensive option), and self-collected
vaginal swab (the second-most expensive). The Colli-Pee® first-void
urine collection device evaluated in the study is manufactured by
OraSure's Belgium-based subsidiary, Novosanis.
“OraSure is committed to delivering
user-friendly tests and collection devices that can be conveniently
used in decentralized settings. The Colli-Pee® collection device
has the potential to reduce cost to the healthcare system, expand
access to screening, and eliminate an invasive, sometimes painful,
procedure for women,” said Carrie Eglinton Manner, President and
Chief Executive Officer of OraSure. “We are excited about the
potential of the Colli-Pee® UCM® device in improving access to
cost-effective HPV screening and enhancing the patient experience
worldwide and are actively engaged in multiple clinical research
and commercial collaborations to establish first-void urine as a
validated sample type for HPV screening, women's health
therapeutics, and the detection of innovative oncology-related
biomarkers,” she said.
According to the World Health Organization, HPV
is responsible for over 99 percent of cervical cancer cases. The
National Cancer Institute reports that half of new HPV cases occur
among unscreened women. The UK-based study found that, if
self-screening led to a 15 percent increase in women accessing the
HPV cervical cancer screening program in England, along with an
additional 50 percent transition to self-screening by women
currently undergoing screening in physician practices, the NHSCSP
could potentially save £19.2 million per year through minimally
invasive first-void urine self-screening or £16.5 million per year
through more invasive vaginal swab-based self-screening. These
figures highlight the significant economic benefits associated with
implementing self-sampling methods.
Overall, this pioneering study underscores the
potential of self-sampling with the Colli-Pee® device as a
cost-effective solution for HPV cervical cancer screening. With its
substantial impact on improving access to screening and reducing
healthcare costs, it holds great promise in advancing women's
health globally.
Full study results can be viewed at
https://bmjopen.bmj.com/content/13/6/e068940.
About OraSure
TechnologiesOraSure Technologies, Inc., 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 NovosanisNovosanis NV, a
subsidiary of OraSure, is an innovator of first-void urine (FVU)
urine sample collection with the Colli-Pee® sample collection
device family to improve the quality of diagnostic tests for
infectious diseases and oncology. The Colli-Pee® devices provide
non-invasive, self-collected, and volumetric sampling to
standardize FVU collection, with a unique design to enable the
immediate mixing of urine and preservative for FVU sample
stability. Offering various sizes to capture a range of urine
volumes for different application purposes, Novosanis is pioneering
FVU sample collection as an alternative to invasive sampling
demonstrated by strong clinical research outcomes, patient
preference and affordability.
Important InformationThis press
release contains certain forward-looking statements, including with
respect to products, product development activities, regulatory
submissions and authorizations, revenue growth, cost savings, cash
flow, increasing margins 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: our ability to
satisfy customer demand; ability to reduce our spending rate,
capitalize on manufacturing efficiencies and drive profitable
growth; ability to achieve the anticipated cost savings as a result
of our business restructuring; 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 FDA or other regulators; the impact
of the novel coronavirus (“COVID-19”) pandemic on the Company's
business, supply chain, labor force, 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, and demand for our COVID-19 testing products; 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 and
the ability to continue to reduce costs; 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 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, civil
unrest, hostilities and war ; and general political, business and
economic conditions, including inflationary pressures and banking
stability. 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, 2022, 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: |
Jason Plagman |
Amy Koch |
VP, Investor Relations |
Director, Corporate Communications |
investorinfo@orasure.com |
media@orasure.com |
OraSure Technologies (NASDAQ:OSUR)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
OraSure Technologies (NASDAQ:OSUR)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024