Quidel Receives 510(k) Clearance for Quidel Triage® TOX Drug Screen, 94600 Toxicology Test for Use With Quidel’s Triage® ...
June 19 2019 - 6:00PM
Business Wire
Quidel Corporation (NASDAQ: QDEL)
(“Quidel”), a provider of rapid diagnostic testing solutions,
cellular-based virology assays and molecular diagnostic systems,
announced today that Quidel has received 510(k) clearance from the
Unites States Food and Drug Administration (FDA) to market the
Quidel Triage® TOX Drug Screen, 94600, a fluorescence immunoassay
for the qualitative determination of the presence of drug and/or
metabolites in human urine of up to 9 drug assays. The test is to
be used with Quidel’s Triage® MeterPro instrumented system.
Drug abuse in the United States continues to be an increasingly
significant social and economic problem. Opiates, cocaine, THC and
amphetamines are recognized by the Substance Abuse and Mental
Health Services Administration (SAMHSA) as the most frequently
abused illicit drugs. Benzodiazepines, tricyclic antidepressants,
barbiturates and opiate compounds are among a group of prescription
drugs that also are frequently abused.
Urine-specific screening tests for drugs of abuse range from
simple immunoassay tests to complex analytical procedures. The
speed and sensitivity of immunoassays have made them the most
accepted method for screening urine for the presence of drugs.
The Quidel Triage TOX Drug Screen, 94600 uses distinct
immunoassays for the simultaneous detection of drug and/or the
urinary metabolites of up to 9 different drug classes. The use of
monoclonal antibodies that are specific for the metabolites of the
9 drug classes ensures a high degree of sensitivity and
specificity. The positive or negative results are typically
displayed on the Quidel Triage MeterPro screen in approximately 15
minutes from the addition of specimen. All results are stored in
the Meter memory to display or print when needed. If connected, the
Meter can transmit results to the laboratory or hospital
information system.
“We believe that our latest diagnostic screening test can play
an important role in providing fast, diagnostic answers to
healthcare providers in the emergency and urgent care settings,”
said Douglas Bryant, president and chief executive officer of
Quidel Corporation. “We are very pleased to receive clearance from
the FDA for our Quidel Triage TOX Drug Screen, 94600 toxicology
test and are optimistic that this assay will drive growth in the
Triage business by delivering a more reliable, higher quality
product to the customer, as well as creating further growth in the
installed base of MeterPro instruments out in the field.”
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 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,
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, 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, 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; our exposure to claims and litigation,
including litigation currently pending against us involving Beckman
Coulter; 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; 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; failure in our information
technology and storage systems; 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; 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/20190619005819/en/
Quidel Contact: Quidel Corporation Randy Steward Chief Financial
Officer (858) 552-7931
Media and Investors Contact: Quidel Corporation Ruben Argueta
(858) 646-8023 rargueta@quidel.com
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