Quidel Corporation (NASDAQ: QDEL), a provider of rapid
diagnostic testing solutions, cellular-based virology assays and
molecular diagnostic systems, announced today it has received
510(k) clearance and Clinical Laboratory Improvements Amendments
(CLIA) waiver from the United States Food and Drug Administration
(FDA) for its Sofia Strep A+ Fluorescent Immunoassay (FIA) to be
used with the Sofia 2 Fluorescent Immunoassay Analyzer for the
rapid detection of infections by Group A Streptococcus bacteria.
These bacteria are one of the more common causes of acute upper
respiratory tract infection.
Sofia 2 is Quidel’s next-generation version of its
best-selling Sofia instrumented immunoassay diagnostic solution
that addresses the specific testing needs of the decentralized
point-of-care (POC) market. Sofia 2 utilizes the original
Sofia’s fluorescent chemistry design while improving upon the
graphical user interface and optics system to provide an accurate,
automated and objective result in 5 minutes.
Sofia 2 integrates a barcode scanner and wireless
connectivity within a smaller footprint than the legacy Sofia
instrument. The next-generation Sofia system also comes connected
to Virena®, Quidel’s data management system, which provides
aggregated, de-identified testing data in near real-time.
The Sofia Strep A+ assay employs advanced lateral flow and
immunofluorescence technologies to provide enhanced clinical
sensitivity for Group A Streptococcus, one of the more serious
respiratory diseases in children and seniors. These technologies
help ensure a reliable, objective, rapid, and accurate diagnostic
result. Early diagnosis and treatment of Group A Streptococcal
pharyngitis has been shown to reduce the severity of symptoms and
serious complications such as rheumatic fever and
glomerulonephritis.1,2
“With the clearance of Sofia Strep A+, Sofia 2 now provides
clinicians at the point-of-care with a powerful diagnostic tool
that quickly and accurately diagnoses three of the more common
respiratory diseases: Influenza A+B, RSV and Strep A. We believe
that the Sofia 2 solution is a perfect fit for the specific
needs of the point-of-care space, especially as we continue to
develop and add incremental assays to the Sofia 2 ecosystem,”
said Douglas Bryant, president and chief executive officer of
Quidel Corporation. “Sofia 2 will build on the successful
legacy of our original Sofia flagship product by expanding our
instrument placements into the smaller, lower volume physician
offices as well as the higher volume health systems, while also
significantly growing our Virena wireless coverage throughout the
country.”
Sofia Strep A+ is the third CLIA-waived assay available on the
Sofia 2 system. Sofia 2 is CLIA-waived for use with the
Sofia Influenza A+B assay as well as the Sofia RSV assay, for the
detection of Respiratory Syncytial Virus.
____________________________________________________________________________________1.
American Academy of Pediatrics. [Group Streptococcal Infection]. In
: Pickering L.K., Baker C.J ., Kimberlin D.W., Long S.S ., eds. Red
Book: 2009 Report of the Committee on Infectious Diseases. 28th ed.
Elk Grove Village, IL: America Academy of Pediatrics;
2009:617-6282. Youmans G.P., Paterson P.Y., and Sommer H.M., Upper
Respiratory Tract Infection: General Considerations, in the
Biological and Clinical Basis of Infectious Disease, W.B. Saunders
Co., Philadelphia, 1980, pp. 177-183
About Quidel Corporation
Quidel Corporation serves to enhance the health and
well-being of people around the globe through the development of
diagnostic solutions that can lead to improved patient outcomes and
provide economic benefits to the healthcare system. Marketed under
the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage®
and InflammaDry® leading brand names, as well as under the new
Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s
products aid in the detection and diagnosis of many critical
diseases and conditions, including, among others, influenza,
respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid
disease and fecal occult blood. Quidel's recently
acquired Triage® system of tests comprises a comprehensive test
menu that provides rapid, cost-effective treatment decisions at the
point-of-care (POC), offering a diverse immunoassay menu in a
variety of tests to provide you with diagnostic answers for
quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and
qualitative TOX Drug Screen. Quidel’s research and development
engine is also developing a continuum of diagnostic solutions from
advanced immunoassay to molecular diagnostic tests to further
improve the quality of healthcare in physicians’ offices and
hospital and reference laboratories. For more information about
Quidel’s comprehensive product portfolio,
visit quidel.com.
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,
fluctuations in our operating results resulting from seasonality,
the timing of the onset, length and severity of cold and flu
seasons, government and media attention focused on influenza and
the related potential impact on humans from novel influenza
viruses, adverse changes in competitive conditions in domestic and
international markets, changes in sales levels as it relates to the
absorption of our fixed costs, lower than anticipated market
penetration of our products, the reimbursement system currently in
place and future changes to that system, changes in economic
conditions in our domestic and international markets, 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 and protection of intellectual property; our
development of new technologies, products and markets; our reliance
on a limited number of key distributors; our reliance on sales of
our influenza diagnostics tests; our ability to manage our growth
strategy; our ability to integrate companies or technologies we
have acquired or may acquire, including integration and transition
risks, the ability to achieve anticipated financial results and
synergies, and effects of disruptions or threatened disruptions to
our relationships, or those of the acquired businesses, with
distributors, suppliers, customers and employees; intellectual
property risks, including but not limited to, infringement
litigation; our debt service requirements; our inability to settle
conversions of our Convertible Senior Notes in cash; the effect on
our operating results from the trigger of the conditional
conversion feature of our Convertible Senior Notes; the possibility
that we may incur additional indebtedness; our need for additional
funds to finance our operating needs; volatility and disruption in
the global capital and credit markets; acceptance of our products
among physicians and other healthcare providers; competition with
other providers of diagnostic products; adverse actions or delays
in new product reviews or related to currently-marketed products by
the FDA or any loss of previously received regulatory
approvals or clearances; changes in government policies; compliance
with other government regulations, such as safe working conditions,
manufacturing practices, environmental protection, fire hazard and
disposal of hazardous substances; third-party reimbursement
policies; our ability to meet demand for our products;
interruptions in our supply of raw materials; product defects;
business risks not covered by insurance and exposure to other
litigation claims; interruption to our computer systems;
competition for and loss of management and key personnel;
international risks, including but not limited to, compliance with
product registration requirements, exposure to currency exchange
fluctuations and foreign currency exchange risk sharing
arrangements, longer payment cycles, lower selling prices and
greater difficulty in collecting accounts receivable, reduced
protection of intellectual property rights, political and economic
instability, taxes, and diversion of lower priced international
products into U.S. markets; dilution resulting from future sales of
our equity; volatility in our stock price; provisions in our
charter documents, Delaware law and our Convertible
Senior Notes 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 (the “SEC”) 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 the results of
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: http://www.businesswire.com/news/home/20171221006123/en/
Quidel Contact:Quidel CorporationRandy StewardChief Financial
Officer(858) 552-7931orMedia and Investors Contact:Quidel
CorporationRuben Argueta(858) 646-8023rargueta@quidel.com
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