Market Overview

Quidel Receives FDA Clearance, CLIA Waiver for Its Point-of-Care Sofia® 2 Lyme Fluorescent Immunoassay for Use with Sofia® 2 Instrument from Finger-Stick Whole Blood Specimens


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.
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.

  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, 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.
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cautioned not to place undue reliance on these forward-looking
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