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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171017005589/en/
Quidel CorporationRandy StewardChief Financial Officer(858)
552-7931orAngie Mazza(312) 690-6006amazza@clermontpartners.com
QuidelOrtho (NASDAQ:QDEL)
Historical Stock Chart
From Aug 2024 to Sep 2024
QuidelOrtho (NASDAQ:QDEL)
Historical Stock Chart
From Sep 2023 to Sep 2024