Proprietary RT-HDA Assay Yields Accurate
Results from up to 11 Samples in 25 Minutes
Simplified Process Requires No Sample
Extraction and Minimal Hands-on Time
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading
provider of rapid diagnostic testing solutions, cellular-based
virology assays and molecular diagnostic systems, announced today
that it has received Emergency Use Authorization (EUA) from the
U.S. Food and Drug Administration (FDA) to market its Solana®
SARS-CoV-2 Assay, an isothermal Reverse Transcriptase -
Helicase-Dependent Amplification (RT-HDA) assay intended for the
qualitative detection of nucleic acid from SARS-CoV-2 in
nasopharyngeal (NP) and nasal (NS) swab specimens in viral
transport media from patients suspected of COVID-19 by their
healthcare provider. Testing is limited to laboratories certified
under the Clinical Laboratory Improvement Amendments of 1988
(CLIA), 42 U.S.C. §263a, to perform high and moderate complexity
tests.
The Solana® SARS CoV-2 offers a number of advantages over
competing laboratory-based molecular diagnostic test protocols for
COVID-19, including: a simple workflow with no sample extraction; a
medium volume throughput design that is ideal for batch testing and
improved laboratory efficiency; and a fast, 25-minute run time for
up to 11 samples. The assay consists of two main steps: (1)
specimen preparation, and (2) amplification and detection of target
sequences specific to SARS-CoV-2 using Quidel’s proprietary
isothermal Reverse Transcriptase – Helicase-Dependent Amplification
(RT-HDA) in the presence of target-specific fluorescence probes.
The Solana® instrument objectively measures and interprets a
fluorescent signal, reports the test results to the user on its
display screen, and can print out the results via an integrated
printer.
Quidel’s Solana® bench-top instrument is designed for maximum
space efficiency and ease of use. The small-profile instrument
features an interactive touchscreen and barcode scanner for easy
data entry, Ethernet and USB ports for data transfer and printing
and compatibility with Dymo Label Writer systems. Solana® also
comes with access to Quidel’s proprietary Virena® data management
and surveillance ecosystem, which provides aggregated,
de-identified testing data to public health authorities in near
real time.
“With so many of our nation’s laboratories overwhelmed by demand
for COVID-19 tests and under pressure to produce more timely
results, there is a compelling societal need for the throughput and
quick runtime offered by our new Solana® molecular testing
technology,” said Douglas Bryant, president and CEO of Quidel
Corporation. “Joining our Lyra® and Lyra® Direct assays for
SARS-CoV-2, we now offer another molecular weapon in the fight
against COVID-19 to quickly diagnose symptomatic patient
populations. The Solana® SARS-CoV-2 Assay nicely complements our
Sofia® and QuickVue® tests that are run at the point-of-care, for
pre-symptomatic, asymptomatic and symptomatic patients. We are
pleased to bring the benefits of our proprietary RT-HDA technology
to detect COVID-19 to the marketplace and further democratize
access to testing across the country. Solana® is a powerful
diagnostic solution at a critical time.”
Solana® is an established Quidel brand with more than 1,000
instruments and ten different 510(k) cleared Solana® diagnostic
assay applications in the market. In addition to laboratories,
Solana® is ideal for use in small- to medium-sized hospitals that
cannot afford the space requirements or expense of traditional
diagnostic machinery. Solana® also eliminates the need for
healthcare facilities to send patient test samples out for
processing -- saving time and costs while reducing the backlog at
central laboratories.
“We are proud of the commitment demonstrated by our Quidel team
since the first day we started developing our PCR, rapid antigen
and HDA tests for COVID-19,” Mr. Bryant added. “Our people have
worked around the clock to create these life-saving diagnostic
innovations and their ability to speed and scale production has
been extraordinary.”
Solana® is a bench top instrument that combines Quidel’s
proprietary helicase-dependent amplification (HDA) with
fluorescence detection to deliver molecular results faster than
ever before. Isothermal amplification eliminates thermal cycling,
operating at one temperature in one tube to reduce the time to
result to as little as 25 minutes. Solana®’s simplified workflow
also avoids the need for specialized molecular operator training,
making Solana easily adoptable in CLIA certified settings.
In addition to the Solana® SARS CoV-2 assay, Quidel’s Solana®
instrument can run a suite of diagnostic assays and panels
including Bordetella, C. Difficile, GAS, GBS, HSV 1+2/VSV,
Influenza A+B, Respiratory Viral Panel, RSV + hMPV, Strep, and
Trichomonas.
Background Information:
Quidel Corporation operates at the forefront of the battle
against the coronavirus pandemic. Quidel received Emergency Use
Authorization (EUA) from the FDA for its Lyra® SARS-CoV-2 Assay, a
real-time RT-PCR test intended for the qualitative detection of
nucleic acid from COVID-19 on March 17, 2020. Lyra® is a leading
molecular test for COVID-19.
On May 8, 2020, Quidel was first to market in the U.S. with a
rapid antigen test that delivers results in 15 minutes. Quidel's
Sofia® SARS Antigen FIA set the bar for antigen test accuracy,
proving to be in agreement with PCR results 96.7% of the time.
Quidel developed the first visually read lateral flow flu test,
the QuickVue® Influenza A/B Test, which received FDA approval in
September of 1999. QuickVue® was also the first flu test cleared by
the FDA for use in CLIA-Waived point-of-care facilities like
doctors’ offices, urgent care clinics and pharmacies.
QuickVue® is a market leading platform for visually diagnosing
Influenza, respiratory syncytial virus (RSV), Strep A and a variety
of other illnesses. Since its FDA approval in 1999, more than 150
million QuickVue® units have been sold.
Sofia® 2 is Quidel’s best-selling cartridge-based, instrument
read rapid diagnostic system for infectious disease testing, which
utilizes fluorescent chemistry design, an intuitive graphical user
interface, and optics system to provide a highly accurate,
objective and automated result in 15 minutes. The Sofia® 2 system
also comes connected to Virena®, Quidel’s data management system,
which provides aggregated, de-identified testing data to public
health authorities in near real time.
Quidel recently doubled its production of Sofia® rapid antigen
tests to the current rate of approximately two million tests per
week. The company is building additional production lines that we
expect will more than double current capacity once again. Our goal
is to reach a run-rate of over 240 million tests per year by the
third quarter of 2021.
About Quidel Corporation
Quidel Corporation (Nasdaq: QDEL) is a leading
manufacturer of diagnostic solutions at the point of care,
delivering a continuum of rapid testing technologies that further
improve the quality of health care throughout the globe. An
innovator for over 40 years in the medical device industry, Quidel
pioneered the first FDA-cleared point-of-care test for influenza in
1999 and was the first to market a rapid SARS-CoV-2 antigen test in
the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage®
and QuickVue®, Quidel’s comprehensive product portfolio includes
tests for a wide range of infectious diseases, cardiac and
autoimmune biomarkers, as well as a host of products to detect
COVID-19. With products made in America, Quidel’s mission is to
provide patients with immediate and frequent access to highly
accurate, affordable testing for the good of our families, our
communities and the world. For more information about Quidel, visit
quidel.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the federal securities laws that involve material
risks, assumptions and uncertainties. Many possible events or
factors could affect our future financial results and performance,
such that our actual results and performance may differ materially
from those that may be described or implied in the forward-looking
statements. As such, no forward-looking statement can be
guaranteed. Differences in actual results and performance may arise
as a result of a number of factors including, without limitation:
the impact and duration of the novel virus (COVID-19) global
pandemic; funding and compliance risks relating to government
contracts, including our ability to meet key deliverables and
milestones under our NIH RADx-ATP contract; our ability to
accurately forecast demand for our products and products in
development, including in new market segments; adverse changes in
competitive conditions, the reimbursement system currently in place
and future changes to that system, changes in economic conditions
in our domestic and international markets, lower than anticipated
market penetration of our products, our reliance on sales of our
influenza and COVID-19 diagnostic tests, fluctuations in our
operating results resulting from the timing of the onset, length
and severity of cold and flu seasons, seasonality, government and
media attention focused on influenza and other respiratory or novel
viruses and the related potential impact on humans from such
viruses, our ability to meet demand for our products; interruptions
or shortages in our supply of raw materials and other components;
the quantity of our product in our distributors’ inventory or
distribution channels, changes in the buying patterns of our
distributors, and changes in the healthcare market and
consolidation of our customer base; our development, acquisition
and protection of proprietary technology rights; our ability to
develop new technologies, products and markets and to commercialize
new products; our reliance on a limited number of key distributors;
our exposure to claims and litigation that could result in
significant expenses and could ultimately result in an unfavorable
outcome for us, including the ongoing litigation between us and
Beckman Coulter, Inc.; intellectual property risks, including but
not limited to, infringement litigation; our ability to finance our
capital or operating needs; the financial soundness of our
customers and suppliers; acceptance of our products among
physicians and other healthcare providers; competition from other
providers of diagnostic products; failures or delays in receipt of
new product reviews or related to currently-marketed products by
the U.S. Food and Drug Administration (the “FDA”) or other
regulatory authorities or loss of any previously received
regulatory approvals or clearances or other adverse actions by
regulatory authorities; changes in government policies; costs of
and adverse operational impact from failure to comply with
government regulations in addition to FDA regulations; compliance
with government regulations relating to the handling, storage and
disposal of hazardous substances; third-party reimbursement
policies and potential cost constraints; our failure to comply with
laws and regulations relating to billing and payment for healthcare
services; product defects; business risks not covered by insurance;
costs and disruptions from failures in our information technology
and storage systems; our exposure to data corruption, cyber-based
attacks, security breaches and privacy violations; competition for
and loss of management and key personnel; international risks,
including but not limited to, compliance with product registration
requirements, compliance with legal requirements, tariffs, exposure
to currency exchange fluctuations and foreign currency exchange
risk, longer payment cycles, lower selling prices and greater
difficulty in collecting accounts receivable, reduced protection of
intellectual property rights, social, political and economic
instability, increased financial accounting and reporting burdens
and complexities, taxes, and diversion of lower priced
international products into U.S. markets; changes in tax rates and
exposure to additional tax liabilities or assessments; our ability
to manage our growth strategy and successfully identify, acquire
and integrate potential acquisition targets or technologies and our
ability to obtain financing; the level of our deferred payment
obligations; that our Revolving Credit Facility is secured by
substantially all of our assets; operating and financial
restrictions on us under the agreements for our indebtedness and
their effect on our ability to operate our business; that an event
of default could trigger acceleration of outstanding indebtedness;
that we may incur additional indebtedness; dilution resulting from
future sales of our equity; volatility in our stock price;
provisions in our charter documents and Delaware law that might
delay or impede stockholder actions with respect to business
combinations or similar transactions; and our intention of not
paying dividends. Forward-looking statements typically are
identified by the use of terms such as “may,” “will,” “should,”
“might,” “expect,” “anticipate,” “estimate,” “plan,” “intend,”
“goal,” “project,” “strategy,” “future,” and similar words,
although some forward-looking statements are expressed differently.
The risks described in reports and registration statements that we
file with the Securities and Exchange Commission from time to time,
should be carefully considered. You are cautioned not to place
undue reliance on these forward-looking statements, which reflect
management’s analysis only as of the date of this press release.
Except as required by law, we undertake no obligation to publicly
release any revision or update of these forward-looking statements,
whether as a result of new information, future events or
otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20201223005469/en/
Quidel Contact: Quidel Corporation Randy Steward Chief Financial
Officer (858) 552-7931
Media and Investors Contact: Quidel Corporation Ruben Argueta
(858) 646-8023 rargueta@quidel.com
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