SAN DIEGO--(BUSINESS WIRE)--Oct. 17, 2017--
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
clearance from the United States Food and Drug Administration (FDA) to
market its Solana® respiratory syncytial virus (“RSV”) +
human metapneumovirus (“hMPV”) Assay for the detection of nucleic acids
isolated from nasal and nasopharyngeal swabs from patients with signs
and symptoms of respiratory infection to aid in the diagnosis of RSV
and/or hMPV infections. The Solana® RSV + hMPV Assay is
intended for use only with the Solana® instrument.
“We are pleased to introduce an additional innovative, rapid testing
solution that addresses the leading cause of viral respiratory
infections in both the young and elderly, RSV and hMPV. This economic
and focused approach to testing to detect and differentiate these
infections replaces expensive syndromic panels or laboratories capable
of performing high complexity testing,” said Douglas Bryant, president
and chief executive officer of Quidel Corporation. “The Solana RSV +
hMPV assay is an easy-to-use, rapid molecular diagnostic test that has
superb clinical accuracy. The assay requires no upfront extraction of
RNA and generates an accurate result in approximately 45 minutes.”
Viral infections are the most frequent causes of morbidity and mortality
due to respiratory dysfunction worldwide, especially in children under
five years of age. Several studies have reported the association of hMPV
and RSV with acute respiratory infection. RSV and hMPV share overlapping
symptoms, and therefore, cannot be identified or differentiated simply
by clinical manifestations(1,2). The most common clinical
symptoms are cough, fever, nasal congestion, and shortness of breath,
but may progress to bronchiolitis or pneumonia. RSV and hMPV are also
important viral respiratory pathogens in the elderly. In adults greater
than 50 years old, hospitalization rates for RSV and HMPV were similar
to those associated with influenza(3).
The Solana molecular platform leverages Quidel’s Helicase-Dependent
Amplification (HDA) technology, and in the case of Solana®
RSV + hMPV Assay, a novel Reverse-Transcriptase HDA that is resident in
Quidel’s AmpliVue® molecular product line to generate a fast
and accurate test result. Solana can process up to 12 patient samples in
each 45-minute run, thereby providing time-saving workflow advantages to
healthcare professionals in moderately complex settings, which is
critical during a busy respiratory season when testing volumes are at
their highest.
The Solana® RSV + hMPV assay received CE Mark in August, and is Quidel’s
seventh molecular diagnostic test to receive 510(k) clearance from the
FDA in the scalable and versatile Solana format.
____________________________________________________________________________________
1) Jacques J, Bouscambert-Duchamp M, Moret H, Carquin J, Brodard V, Lina
B, et al. Association of respiratory picornaviruses with acute
bronchiolitis in French infants. J Clin Virol. 2006; 35(4):
463-6[DOI][PubMed]
2) Matthew J, Pinto Pereira LM, Pappas TE, Swenson CA, Grindle KA,
Roberg KA, et al. Distribution and seasonality of rhinovirus and other
respiratory viruses in a cross-section of asthmatic children in
Trinidad, West Indies. Ital J Pediatr. 2009; 35:
16[DOI][PubMed]
3) Kyle
Widmer, Yuwei
Zhu, John
V. Williams, Marie
R. Griffin, Kathryn
M. Edwards, and H.
Keipp Talbot. Rates of Hospitalizations for Respiratory Syncytial
Virus, Human Metapneumovirus, and Influenza Virus in Older Adults. J
Infect Dis. 2012 Jul 1; 206(1): 56–62.
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.
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, 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
Randy Steward
Chief Financial Officer
(858)
552-7931
or
Angie Mazza
(312) 690-6006
amazza@clermontpartners.com