Market Overview

Quidel Receives FDA Clearance for Its Point-of-Care Sofia® Lyme Fluorescent Immunoassay for Use with Sofia® 2 Instrument


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 Sofia 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 serum
and plasma specimens from patients suspected of B. burgdorferi
infection. The test is intended for use with either the Sofia or 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, automated and objective 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 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 Lyme Assay's 510(k) clearance for use on the Sofia 2
instrument will allow healthcare workers to generate a faster result,
thereby accelerating the 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 Lyme
results," said Douglas Bryant, president and chief executive officer of
Quidel Corporation. "We expect that this new product introduction will
increase the utilization of our Sofia 2 platform, and could create
incremental instrument placement opportunities in the near to medium

The Sofia Lyme Assay was previously 510(k) cleared for use on the Sofia
instrument. This new 510(k) clearance allows the assay to also be run on
the Sofia 2 instrument. The Sofia Lyme Assay is the fourth 510(k)
cleared Sofia test for use on the Sofia 2 system: the Sofia Influenza
A+B Assay, the Sofia RSV Assay, and the Sofia Strep A+ Assay were 510(k)
cleared and CLIA waived by the FDA in 2017.

  1. 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.
  2. CDC.
  3. 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

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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