SAN DIEGO--(BUSINESS WIRE)--Jun. 7, 2017--
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic
testing solutions, cellular-based virology assays and molecular
diagnostic systems, announced today it has received the CE Mark for
Quidel’s Thyretain® TBI Reporter BioAssay for the qualitative detection
of blocking autoantibodies to the thyroid-stimulating hormone receptors
(TSHR) in serum.
According to the Centers for Disease Control and Prevention (CDC),
autoimmune diseases are the third most common category of disease in the
United States after cancer and heart disease. Autoimmune diseases affect
roughly 14–22 million persons, and approximately 80% of the persons
affected with autoimmune diseases are women.1
One such autoimmune disease, autoimmune thyroiditis (AT) or Hashimoto’s
disease, is a chronic inflammatory disorder of the thyroid gland that is
caused by abnormal blood antibodies and white blood cells that
mistakenly attack and damage healthy thyroid cells.2 In
autoimmune thyroiditis, thyroid-blocking immunoglobulin, or TBI,
prevents or blocks the TSH from binding to its own receptor, TSHR. This
event stops the intracellular signaling cascade required for the
production and secretion of thyroid hormones. AT is characterized by a
deficiency of thyroid hormone.
Autoimmune thyroiditis begins slowly. It may take months or even years
for the condition to be detected and for thyroid hormone levels to
become lower than normal.3 Possible signs and symptoms of
hypothyroidism can include: memory loss, fatigue and sluggishness,
increased sensitivity to cold, constipation, pale, dry skin, hair loss,
enlargement of the tongue, unexplained weight gain, muscle aches,
stiffness, and depression.4 Therefore, it is important to
provide a diagnostic method to detect the thyroid blocking antibodies
that can aid physicians in patient care.
Quidel’s Thyretain TBI Reporter BioAssay utilizes a patented bioassay
technology to detect TBI in human serum. Until now, no specific TBI
detecting method was available in the market. The assay enables highly
complex laboratories to quickly diagnose autoimmune thyroiditis in just
a few days.
“We’ve developed a test that can truly make a difference in the lives of
those who are suffering from AT, a disease that can take years to
diagnose,” said Douglas Bryant, president and chief executive officer of
Quidel Corporation. “We are pleased to expand our Thyretain franchise,
and to bring meaningful solutions to key issues that affect patients
globally.”
The assay is currently available for sale in Europe, and not yet
available for sale in the United States.
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https://wwwnc.cdc.gov/eid/article/10/11/04-0367_article
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http://www.webmd.com/women/autoimmune-thyroiditis
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https://medlineplus.gov/ency/article/000371.htm
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http://www.mayoclinic.org/diseases-conditions/hashimotos-disease/home/ovc-20269762
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® 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 research and development engine is also
developing a continuum of diagnostic solutions from advanced
lateral-flow and direct fluorescent antibody 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.
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, including our ability to integrate companies
or technologies we have acquired or may acquire; 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 U.S. Food and Drug Administration
(the “FDA”); 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 Contact:
Quidel Corporation
Randy Steward
Chief
Financial Officer
(858) 552-7931
or
Media and Investors
Contact:
Quidel Corporation
Ruben Argueta
(858) 646-8023
rargueta@quidel.com