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 from the United States Food and Drug
Administration (FDA) for its Solana® GBS Assay for the direct,
qualitative detection of Group B Streptococcus from enriched broth
cultures of specimens from antepartum women.
GBS is responsible for illness in people of all ages, but it is
a particularly serious pathogen for newborns in whom the infection
can cause life-threatening sepsis, pneumonia and sometimes
meningitis with a risk for long lasting effects, including deafness
and developmental disabilities.1 According to the Centers for
Disease Control and Prevention (CDC), roughly 20% to 30% of
pregnant women carry GBS that can be transmitted to the newborn at
delivery. CDC guidelines recommend that all pregnant women should
be tested for GBS infection between 35 and 37 weeks of
pregnancy.2
Although more rare, serious GBS infections can also occur in
adults, leading to bloodstream infections, pneumonia, and other
infections that can be fatal.3
The Solana GBS Assay is an easy-to-use, molecular diagnostic
test that generates an accurate result from either LIM or Carrot
enrichment broth cultures of vaginal/rectal swabs from antepartum
women following 18 to 24 hours of incubation.
The Solana molecular platform leverages the Helicase-Dependent
Amplification (HDA) technology that is resident in Quidel’s
AmpliVue® molecular product line to generate a fast and accurate
test result. Solana can process up to 12 different assays or
patient samples in each batched run, and provides time-saving
workflow advantages to healthcare professionals in moderately
complex settings.
“We are pleased to receive 510(k) clearance for our Solana GBS
assay, a test that can potentially be life-saving or life-changing
for those that are most vulnerable: newborns,” said Douglas Bryant,
president and chief executive officer of Quidel Corporation. “From
Respiratory Diseases to Sexually Transmitted Infections to
Healthcare Associated Infections, our Solana systems are quickly
and accurately diagnosing real-world disease states in a
cost-effective manner, while addressing the specific workflow needs
of laboratorians in the moderately complex setting.”
The Solana instrumented system offers a comprehensive set of
510(k)-cleared assays that allows laboratories to quickly diagnose
many diseases such as Influenza A+B, Strep Complete (Groups A+C/G),
RSV+hMPV, HSV 1+2/VZV, Trichomonas, and C. difficile.
The commercial introduction of Solana has broadened Quidel’s
molecular strategy to include instrumented systems, and grown the
number of its molecular platforms that are both 510(k) cleared and
available commercially. Quidel’s other FDA cleared molecular
solutions include the AmpliVue® non-instrumented system for
lower-volume moderately complex labs, and Lyra® reagents for higher
throughput, highly complex laboratories that are compatible with
existing PCR infrastructure.
1 http://www.cdc.gov/groupbstrep/about/index.html2
http://www.cdc.gov/groupbstrep/about/fast-facts.html3
http://www.cdc.gov/groupbstrep/about/adults.html
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/20171221006119/en/
Quidel CorporationQuidel Contact:Randy Steward,
858-552-7931Chief Financial OfficerorMedia and Investors
Contact:Ruben Argueta, 858-646-8023rargueta@quidel.com
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