Log in
Forgot password ?
Become a member for free
Sign up
Sign up
Dynamic quotes 

4-Traders Homepage  >  Equities  >  Nasdaq  >  Quidel Corporation    QDEL

News SummaryMost relevantAll newsSector newsTweets 

QUIDEL VTG : Quidel Announces FDA Clearance of Its QuickVue® RSV 10 Immunoassay Diagnostic Test

share with twitter share with LinkedIn share with facebook
share via e-mail
09/29/2010 | 01:05pm CEST

Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its QuickVue® RSV 10, a lateral flow immunoassay test for the qualitative detection of acute respiratory syncytial virus (RSV) infections.

Almost all infants will suffer from an RSV infection before the age of two. According to the United States Centers for Disease Control and Prevention, RSV is the most common cause of bronchiolitis and pneumonia in children under one year of age in the United States resulting in between 75,000 and 125,000 children hospitalized annually because of an RSV infection.1, 2

QuickVue RSV 10 detects RSV antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients under the age of six.

?The signs of an RSV infection are often similar to other respiratory infections, and diagnosis by symptoms alone can be difficult. Our new QuickVue RSV 10 product is a reliable, easy-to-use aid in detecting RSV in children. This new product will be available for the upcoming RSV season, which normally begins in November,? said Douglas Bryant, president and chief executive officer of Quidel Corporation. ?QuickVue RSV 10 offers results in 10 minutes, which can provide a significant time savings to healthcare professionals.?

QuickVue RSV 10 employs the identical test method and sample preparation of the QuickVue® Influenza A+B test, allowing for the use of the same nasopharyngeal patient specimen when testing for influenza or an RSV infection.

1Centers for Disease Control and Prevention website: http://www.cdc.gov/rsv/about/faq.html

2March of Dimes website: http://www.marchofdimes.com/pnhec/298_9546.asp

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 leading brand names QuickVue®, D3® Direct Detection and Thyretain?, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including 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 www.quidel.com and Diagnostic Hybrids at www.dhiusa.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, seasonality, the timing of onset, length and severity of cold and flu seasons, the level of success in executing on our strategic initiatives, our reliance on sales of our influenza diagnostic tests, uncertainty surrounding the detection of novel influenza viruses involving human specimens, our ability to comply with the covenants in our senior credit facility, our ability to develop new products and technologies, adverse changes in the competitive and economic conditions in domestic and international markets, our reliance on and actions of our major distributors, technological changes and uncertainty with research and technology development, including any molecular-based technology, the medical reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration, our ability to comply with FDA, environmental and other regulations, our ability to meet unexpected increases in demand for our products, our ability to execute our strategy, including the integration of new companies or technologies, disruptions in the global capital and credit markets, our ability to hire key personnel, intellectual property, product liability, environmental or other litigation, potential required patent license fee payments not currently reflected in our costs, adverse changes in our international markets, including as a result of currency fluctuations, political instability or new or increased tariffs, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated sales or market penetration of our new products. Forward-looking statements typically are identified by the use of terms such as "may," "will," "should," "might," "expect," "anticipate," "estimate," and similar words, although some forward-looking statements are expressed differently. The risks described under "Risk Factors" in reports and registration statements that we file with 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. We undertake no obligation to publicly release the results of any revision or update of the forward-looking statements, except as required by law.

Quidel Contact:
Quidel Corporation
John M. Radak, Chief Financial Officer
Media and Investors Contact:
Quidel Corporation
Ruben Argueta
[email protected]

© Business Wire 2010
share with twitter share with LinkedIn share with facebook
share via e-mail
01:27a QUIDEL CO. (NASDAQ : QDEL) reported earnings of $0.45 per share beating Walls St..
04/24 QUIDEL : posts 1Q profit
04/24 QUIDEL CORPORATION (NASDAQ : QDEL) Files An 8-K Results of Operations and Financ..
04/24 QUIDEL CORP /DE/ : Results of Operations and Financial Condition, Financial Stat..
04/24 QUIDEL : Reports First Quarter 2017 Financial Results
04/12 QUIDEL : to Hold First Quarter 2017 Financial Results Conference Call on April 2..
03/27 QUIDEL CORPORATION (NASDAQ : QDEL) Files An 8-K Departure of Directors or Certai..
03/13 QUIDEL CORPORATION (NASDAQ : QDEL) Files An 8-K Regulation FD Disclosure
03/13 QUIDEL CORP /DE/ : Regulation FD Disclosure (form 8-K)
03/03 QUIDEL : to Present at the Barclays Global Healthcare Conference
More news
Sector news : Advanced Medical Equipment & Technology - NEC
04/24DJPHILIPS : Net Profit Leaps; Backs Full Year Guidance
04/10DJCorrections & Amplifications -- WSJ
03/28DJPHILIPS : to Buy Australian pharmacy Sleep Services Firm
02/09 Infineon, Cree warn U.S. might block Wolfspeed deal
02/02 EU probes online sales in electronics, video games, hotels
More sector news : Advanced Medical Equipment & Technology - NEC
News from SeekingAlpha
04/24 Quidel Corporation's (QDEL) CEO Doug Bryant on Q1 2017 Results - Earnings Cal..
04/24 Quidel Corporation 2017 Q1 - Results - Earnings Call Slides
04/24 Quidel beats by $0.16, beats on revenue
04/23 Notable earnings after Monday?s close
02/08 Quidel Corporation's (QDEL) CEO Doug Bryant on Q4 2016 Results - Earnings Cal..
Financials ($)
Sales 2017 220 M
EBIT 2017 27,0 M
Net income 2017 5,74 M
Debt 2017 8,99 M
Yield 2017 -
P/E ratio 2017 135,60
P/E ratio 2018 61,84
EV / Sales 2017 3,58x
EV / Sales 2018 3,33x
Capitalization 779 M
More Financials
Duration : Period :
Quidel Corporation Technical Analysis Chart | QDEL | US74838J1016 | 4-Traders
Full-screen chart
Technical analysis trends QUIDEL CORPORATION
Short TermMid-TermLong Term
Technical analysis
Income Statement Evolution
More Financials
Mean consensus HOLD
Number of Analysts 7
Average target price 23,0 $
Spread / Average Target -2,1%
Consensus details
EPS Revisions
More Estimates Revisions
Douglas C. Bryant President, Chief Executive Officer & Director
Kenneth F. Buechler Chairman
Edward Kieth Russell Senior Vice President-Global Commercial Operations
Randall J. Steward CFO & Principal Accounting Officer
Werner Kroll Senior Vice President-Research & Development
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
PHILIPS5.16%31 920
More Results