SAN DIEGO--(BUSINESS WIRE)--Dec. 21, 2017--
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.
1http://www.cdc.gov/groupbstrep/about/index.html
2
http://www.cdc.gov/groupbstrep/about/fast-facts.html
3
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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Source: Quidel Corporation
Quidel Corporation
Quidel Contact:
Randy Steward, 858-552-7931
Chief
Financial Officer
or
Media and Investors Contact:
Ruben
Argueta, 858-646-8023
rargueta@quidel.com