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 and Clinical Laboratory Improvement
Amendments (CLIA) waiver from the United States Food and Drug
Administration (FDA) to market its Sofia 2 Lyme FIA to be used with
the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid
differential detection of human IgM and IgG antibodies to Borrelia
burgdorferi from finger-stick whole blood specimens from patients
suspected of B. burgdorferi infection. The test is intended for use
with the Sofia 2 analyzer to aid in the diagnosis of Lyme
disease.
Sofia 2 is Quidel’s next-generation version of its best-selling
Sofia instrumented system. Sofia 2 utilizes the original Sofia’s
fluorescent chemistry design while improving upon the graphical
user interface and optics system to provide an accurate, objective
and automated result in as few as 3 minutes. Sofia 2 also
integrates wireless connectivity and its barcode scanner within a
smaller footprint than the legacy Sofia instrument. The
next-generation Sofia 2 system also comes connected to Virena®,
Quidel’s data management system, which provides aggregated,
de-identified testing data in near real-time.
Lyme disease is the most common tickborne disease in North
America and Europe1. In the United States, Lyme disease is caused
by the bacterium, Borrelia burgdorferi, transmitted through the
bite of an infected blacklegged tick1,2. Patients infected with B.
burgdorferi may experience symptoms associated with three stages:
early localized disease, early disseminated disease, and late
persistent disease1. The most characteristic symptom of early
localized disease is the appearance of erythema migrans (EM) on the
skin1,3. EM may also be accompanied by flu-like symptoms days or
weeks after infection3. In the second stage, early disseminated
disease, untreated patients may begin to see neurological and
rheumatological manifestations, and less commonly, dermatological,
cardiac, or ophthalmological manifestations. These symptoms
generally appear weeks to months after infection1. If the disease
continues to be left untreated, late persistent disease may also
follow months or years later with continued progression of
manifestations in the joints, heart, skin, and nervous
system2,3.
Early detection and treatment of Lyme disease can help resolve
symptoms and prevent progression of the disease1. The primary means
of identifying B. burgdorferi infection is detection of the body’s
IgM and IgG antibody response by way of immunoassay3. Detection of
IgM antibodies to B. burgdorferi is generally most significant in
the earlier stages of the disease. Conversely, detection of IgG
antibodies has proven to be significant for longer periods, as the
antibodies may remain detectable years after infection.
The Sofia 2 Lyme FIA uses a bi-directional test strip format to
detect both IgM and IgG antibodies to B. burgdorferi from a single
finger-stick whole blood sample. One side of the test strip detects
IgM antibodies to B. burgdorferi and the other side of the test
strip detects IgG antibodies to B. burgdorferi.
The Sofia 2 Lyme FIA is also novel in that it can process
samples from less invasive finger-stick whole blood specimens
instead of blood samples collected though venipuncture, the
traditional method of sample collection for Lyme testing. The
assay’s whole blood sample processing technology speeds the time to
diagnosis, is less invasive to the patient, and allows the test to
be CLIA waived by the FDA.
CLIA waiver for the Sofia 2 Lyme FIA markedly expands the
available market for the Sofia 2 test system, which allows the test
to be run in physician offices, as well as in several thousand
hospitals, medical centers, smaller clinics, and alternate sites
(e.g., urgent care centers, free standing emergency departments,
retail clinics, etc.) in the United States.
“The Sofia 2 Lyme FIA’s 510(k) clearance and CLIA Waiver for use
on the Sofia 2 instrument will allow healthcare workers to generate
a result in a single office visit, accelerating the time to
diagnosis and potential treatment of Lyme Disease for the patient.
This is another example of our ability to provide simple,
cost-effective solutions for physician offices and hospitals that
previously had to wait several days for send-out results,” said
Douglas Bryant, president and chief executive officer of Quidel
Corporation. “We expect that this new product introduction will
increase the value of our Sofia 2 platform, and could create
incremental instrument placement opportunities in traditional
healthcare institutions that are closer to the patient, as well as
in the rapidly growing alternate site segment of point of
care.”
The Sofia 2 Lyme FIA is the fourth Sofia test for use on the
Sofia 2 system that has been 510(k) cleared and CLIA waived by the
FDA: the Sofia Influenza A+B FIA, the Sofia RSV FIA, and the Sofia
Strep A+ FIA were 510(k) cleared and CLIA waived by the FDA in
2017. Quidel also markets the moderately complex Sofia Lyme FIA in
the US, as well as Sofia Legionella FIA and Sofia S. pneumoniae FIA
in Europe.
- Wormser, G. P., Dattwyler, R. J.,
Shapiro, E. D., Halperin, J. J., Steere, A. C., Klempner, M. S.,
Nadelman, R. B. (2006). The Clinical Assessment, Treatment, and
Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and
Babesiosis: Clinical Practice Guidelines by the Infectious Diseases
Society of America. Clinical Infectious Diseases, 43(9),
1089-1134.
- CDC.
http://www.cdc.gov/lyme/diagnosistesting/LabTest/TwoStep/index
- Aguero-Rosenfeld, M. E., Wang, G.,
Schwartz, I., & Wormser, G. P. (2005). Diagnosis of Lyme
Borreliosis. Clinical Microbiology Reviews, 18(3), 484-509.
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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version on businesswire.com: https://www.businesswire.com/news/home/20180830005891/en/
Quidel Contact:Quidel CorporationRandy StewardChief Financial
Officer(858) 552-7931orMedia and Investors Contact:Quidel
CorporationRuben Argueta(858) 646-8023rargueta@quidel.com
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