SAN DIEGO--(BUSINESS WIRE)--Jul. 16, 2018--
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid
diagnostic testing solutions, cellular-based virology assays and
molecular diagnostic systems, announced today that it has received
510(k) clearance from the United States Food and Drug Administration
(FDA) to market its Solana Bordetella Complete Assay, a molecular
diagnostic assay to be used with the Solana molecular diagnostic
instrument for the qualitative detection and differentiation of Bordetella
pertussis and Bordetella parapertussis nucleic acids isolated
from nasopharyngeal swab specimens obtained from patients suspected of
having a respiratory tract infection attributable to Bordetella
pertussis and Bordetella parapertussis.
Pertussis, or whooping cough, is a very contagious disease caused by the Bordetella
pertussis bacteria, which attach to the cilia that line part of the
upper respiratory tract, causing inflammation through the release of
toxins, which cause airways to swell.1 Pertussis is spread
from person to person through the inhalation of bacteria from an
infected person’s cough or sneeze. Symptoms, such as a runny nose,
low-grade fever, or mild cough usually develop within 5–10 days after
exposure, but sometimes appear as long as 3 weeks later. Although
whooping cough can cause serious illness in children and adults, it is
most dangerous for infants and babies. According to the Centers for
Disease Control and Prevention (CDC), about half of infants younger than
1 year of age who get this disease require hospitalization.2
The incidence of pertussis has risen steadily over the last few years.3
Factors that have likely contributed to the increased incidence of
pertussis include a decline in vaccine use, waning vaccine-induced
immunity in adolescent and adult populations, failure to receive booster
shots later in life, and continued circulation of B. pertussis in
our population.4-5
According to the CDC, B. parapertussis causes a pertussis-like
illness that is generally milder than pertussis, likely because the
bacteria do not produce pertussis toxin. Co-infection of B. pertussis
and B. parapertussis can occur but is uncommon.6B.
parapertussis is not easily distinguished from B. pertussis
infection by symptoms, and unlike B. pertussis, usually it is not
laboratory confirmed. For these reasons, the epidemiology of illness
caused by B. parapertussis is poorly recognized.7
The Solana Bordetella Complete Assay 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 on
the Solana molecular diagnostic instrument. The assay targets the IS481
and IS1001 sequence of the Bordetella pertussis and Bordetella pertussis
genomes, respectively.
The Solana molecular diagnostic instrument can process up to 12 patient
samples in each batched run, and provides time-saving workflow
advantages to healthcare professionals in moderately complex settings.
Solana also comes connected to Virena®, Quidel’s data management system,
which provides aggregated, de-identified testing data in near real-time.
“We are pleased to receive 510(k) clearance for our Solana Bordetella
Complete Assay, as this test rounds out our Solana molecular test
offering in the respiratory category,” said Douglas Bryant, president
and chief executive officer of Quidel Corporation. “Although whooping
cough cases can be sporadic, outbreaks are often highly contagious, and
we believe that this test can provide healthcare workers with the
ability to quickly diagnose whooping cough and B. parapertussis.
When paired with Quidel’s Virena ecosystem, clinicians will be able to
see real-time positive cases at the local level, giving them further
insights into disease prevalence for both parapertussis and pertussis.”
The Solana instrumented system offers a comprehensive set of
510(k)-cleared assays that allows laboratories to quickly process
multiple patient samples to diagnose many diseases such as Influenza
A+B, Strep Complete (Groups A+C/G), RSV+hMPV, HSV 1+2/VZV, Trichomonas,
Group B Strep, 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/pertussis/about/causes-transmission.html
2)
http://www.cdc.gov/pertussis/about/signs-symptoms.html
3)
CDC. Provisional Pertussis Surveillance Report. 2013. http://www.cdc.gov/pertussis/downloads/pertussis-surveillance-report.pdf
4)
Versteegh FGA, Schellekens JFP, Fleer A, Roord JJ. Pertussis: a concise
historical review including diagnosis, incidence, clinical
manifestations and the role of treatment and vaccination in management
Rev Med Microbiol 2005; 16 (3): 79-89.
5) Atwell JE, Van Otterloo
J, Zipprich J, Winter K, Harriman K, Salmon DA, Halsey NA, Omer SB.
Nonmedical vaccine exemptions and pertussis in California, 2010. Pediatrics
2013; 132 (4): 624–30.
6) https://www.cdc.gov/vaccines/pubs/surv-manual/chpt10-pertussis.html
7)
Mastrantonio P, Stefanelli P, Giuliano M., Herrera Rojas Y, Ciofi Degli
Atti M, Anemoa A Tozzi AE. Bordetella pertussis infection in children:
epidemiology, clinical symptoms, and molecular characteristics of
isolates, 1998. Journal of Clinical MicrobiologyApril 1998: 999-1002.
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 healthcare
providers 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.
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, our reliance on sales of our influenza
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 the
related potential impact on humans from novel influenza viruses, adverse
changes in competitive conditions in domestic and international markets,
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, 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 proprietary technology rights; our
development of new technologies, products and markets; our reliance on a
limited number of key distributors; intellectual property risks,
including but not limited to, infringement litigation; our need for
additional funds 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
with other providers of diagnostic products; adverse actions or delays
in 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; changes in government policies; our exposure to claims and
litigation, including litigation currently pending against us; costs of
or our 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; our failure to comply with laws and regulations
relating to billing and payment for healthcare services; our ability to
meet demand for our products; interruptions in our supply of raw
materials; product defects; business risks not covered by insurance; our
exposure to cyber-based attacks and security breaches; 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; changes in tax rates and exposure to additional tax
liabilities or assessments; risks relating to the acquisition and
integration of the Triage and BNP Businesses; Alere’s failure to perform
under various transition agreements relating to our acquisition of the
Triage and BNP Businesses; that we may incur substantial costs to build
our information technology infrastructure to transition the Triage and
BNP Businesses; that we may have to write off goodwill relating to our
acquisition of the Triage and BNP Businesses; that we our ability to
manage our growth strategy; the level of our indebtedness; the amount
of, and our ability to repay, renew or extend, our outstanding debt and
its impact on our operations and our ability to obtain financing; that
substantially the Senior Credit Facility is secured by substantially all
of our assets; our prepayment requirements under the Senior Credit
Facility; the agreements for our indebtedness place operating and
financial restrictions on the Company; that an event of default could
trigger acceleration of our outstanding indebtedness; 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; that we may incur additional
indebtedness; increases in interest rate relating to our variable rate
debt; dilution resulting from future sales of our equity; volatility in
our stock price; provisions in our charter documents, Delaware law and
the indenture governing 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 Contact:
Quidel Corporation
Randy Steward
Chief
Financial Officer
(858) 552-7931
or
Media and Investors
Contact:
Quidel Corporation
Ruben Argueta
(858) 646-8023
rargueta@quidel.com