OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that it
has received Emergency Use Authorization (EUA) from the U.S. Food
and Drug Administration (FDA) for its COVID-19 rapid antigen tests,
which the Company is branding as InteliSwab™. These tests detect
active COVID-19 infection. The FDA has authorized the InteliSwab™
COVID-19 Rapid Test for Over-the-Counter (OTC) use without a
prescription. FDA has also authorized the InteliSwab™ COVID-19
Rapid Test Pro for professional use in point of care (POC)
CLIA-waived settings, and the InteliSwab™ COVID-19 Rapid Test Rx
for Prescription Home Use.
OraSure will market three versions of
InteliSwab™:
- InteliSwab™ COVID-19 Rapid Test:
The OTC home test for use without a prescription in individuals 15
years or older (with or without symptoms) when tested twice over
two or three days with at least 24 and no more than 36 hours
between tests.
- InteliSwab™ COVID-19 Rapid Test
Pro: The Professional Test, which is packaged in bulk
configurations, is authorized for use at the point of care in
healthcare settings operating under a CLIA Certificate of Waiver,
Certificate of Compliance, or Certificate of Accreditation, for
individuals 15 years or older who are suspected of COVID-19 by
their healthcare provider within 7 days of symptom onset or for
individuals without symptoms when tested twice over two or three
days with at least 24 hours and no more than 36 hours between
tests.
- InteliSwab™ COVID-19 Rapid Test Rx:
The prescription home test is authorized for prescription home use
with self-collection (unobserved) of anterior nasal samples from
individuals 18 years or older or adult collected samples from
individuals age 15 years or older who are suspected of COVID-19
infection by their healthcare provider within the first seven (7)
days of symptom onset.
The unique design of InteliSwab™ incorporates a
built-in swab that is fully integrated into the test stick,
simplifying the entire testing process. Use of this integrated swab
also helps ensure supply continuity, as InteliSwab™ does not
require sourcing scarce nasal swabs. Testing with InteliSwab™ is
simple: users swab their lower nostrils with the test stick, swirl
it in a pre-measured solution, and see their result on the test
stick in 30 minutes – with no instruments, batteries, smartphone or
laboratory analysis needed to see the result. Using InteliSwab™ to
test for COVID-19 requires less than one minute of “hands-on”
time.
In a clinical study at five independent US
sites, InteliSwab™ had strong performance, with positive results
agreeing with highly sensitive FDA-authorized PCR tests 84% of the
time, and negative results agreeing 98% of the time. In addition,
98% of consumers in the clinical trial found InteliSwab™
easy-to-use.
“OraSure is on a mission to make COVID-19
testing dramatically simpler. We believe that this easy and
intuitive ‘swab, swirl and see’ test will be one of the simplest
COVID-19 tests on the market. We expect that InteliSwab’s™
simplicity and accuracy will give users peace of mind that they
performed the test correctly and can rely on the results,” said
OraSure President and CEO Stephen Tang, Ph.D. “Simple and
accessible at-home tests, like InteliSwab™, make it easier for
individuals to know if they are infectious and to quickly
self-isolate if they test positive. With InteliSwab™, we believe
OraSure will play an even larger role in safely reopening – and
keeping open – workplaces, schools and other places where people
congregate.”
The Company’s installed manufacturing capacity
for InteliSwab™ is currently 55 million units annually; the Company
will be ramping up to a production capacity of 70 million units
annually in the third quarter of 20211.
OraSure will be completing the required post
market studies as specified in the FDA authorization letter which
can be found at InteliSwab.com or on the FDA website at
fda.gov.
Visit InteliSwab.com for more details.
The Company has built product inventory at risk,
but because the EUAs require updates to labelling the Company is
expecting only nominal, if any, InteliSwab™ revenue in the second
quarter of 2021. The Company plans to provide an update on its
expectations for InteliSwab™ revenue at or before its second
quarter earnings call in August.
The pan-SARS-coronavirus antigen rapid in-home
self-test project has been funded in whole or in part with federal
funds from the Department of Health and Human
Services, Office of the Assistant Secretary for Preparedness
and Response; Biomedical Advanced Research and Development
Authority, under Contract No. 75A50120C00061.
OraSure’s Response to
COVID-19OraSure is leveraging its expertise in infectious
disease testing and molecular sample collection to advance COVID-19
testing and sample collection solutions across three modalities:
Antigen, Molecular/PCR, and Antibody. The Company’s portfolio of
COVID-19 tests and collection kits all feature easy, convenient,
pain-free self-collection, and help increase access to testing,
while alleviating the burden on the healthcare system and
minimizing exposure risks.
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 expected revenues, 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: ability to successfully manage and integrate
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; impact of increased or different risks arising from
the acquisition of companies located in foreign countries; 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 our business and our 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;
ability to identify, complete, integrate and realize the full
benefits of future acquisitions; 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, 2020, 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.
1 Manufacturing capacity numbers include existing tests for HIV,
HCV and Ebola.
Investor
Contact:Scott GleasonSVP Investor Relations & Corporate
Communications484-425-0588sgleason@orasure.com |
|
Media
Contact:Amy KochSr. Mgr. Corporate
Communications484-523-1815media@orasure.com |
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/b0875e37-ad0b-4761-bc61-4141d6a221a3
A video accompanying this announcement is available
at https://www.globenewswire.com/NewsRoom/AttachmentNg/92f1e416-146d-4cf4-a166-17f635cf9f91
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