Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

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

SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 

Quidel Corporation : Quidel Receives 510(k) Clearance of Its Sofia(TM) Fluorescent Immunoassay Analyzer and Influenza A+B FIA Test

share with twitter share with LinkedIn share with facebook
share via e-mail
0
10/26/2011 | 08:00pm CEST

SAN DIEGO, CA, Oct 26, 2011 (MARKETWIRE via COMTEX) --

Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its Sofia(TM) Analyzer and its Sofia Influenza A+B FIA.

Sofia is the brand name for Quidel's next generation immunoassay system. The easy-to-use Sofia Analyzer and Sofia Influenza A+B FIA combine unique software and fluorescent chemistry to yield an automatic, objective result that is readily available on the instrument's screen, in a hard-copy printout, and in a transmissible electronic form that can network via an LIS system to hospital and medical center databases. The Sofia FIA employs advanced lateral flow and immunofluorescence technologies to provide enhanced clinical sensitivity for influenza A and B. The Sofia Analyzer provides for different operational modes to accommodate both small and large laboratories, as well as other features designed to facilitate use in a variety of healthcare settings, including hospitals, medical centers, and small clinics. These features help ensure a reliable, objective, rapid, and accurate diagnostic result.

"We are very pleased with the FDA clearance of our Sofia Analyzer and Sofia Influenza A+B FIA," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "This announcement represents the achievement of a significant milestone, and positions us in the marketplace with a strategically important platform that will provide numerous benefits to healthcare providers and their patients."

The Sofia Influenza A+B Fluorescent Immunoassay is the first in a series of new Quidel immunofluorescent assays for infectious disease and other conditions or disorders that will use the very same Sofia Analyzer. The 510(k) clearance grants Quidel permission to sell both the Sofia Analyzer and the Sofia Influenza A+B FIA in the United States in advance of the upcoming influenza and respiratory disease season. Both the Sofia Analyzer and the Sofia Influenza A+B FIA received the CE Mark in August 2011, and are thus already available for sale in Europe and other ex-U.S. locations, and they are now available for commercial distribution in the United States.

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 QuickVue(R), D3(R) Direct Detection and Thyretain(R) leading brand names, as well as under the new Sofia(TM) and Quidel Molecular brands, 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 and Diagnostic Hybrid's comprehensive product portfolio, visit quidel.com and 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 develop new products and technology, 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 (the "FDA"), 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, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated acceptance, 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
(858) 646-8032

Media and Investors Contact:
Quidel Corporation
Ruben Argueta
(858) 646-8023
Email Contact

SOURCE: Quidel Corporation

http://www2.marketwire.com/mw/emailprcntct?id=6EB3C687D4DB029C
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on QUIDEL CORPORATION
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
02/28 QUIDEL CORP /DE/ : Change in Directors or Principal Officers (form 8-K)
02/22 QUIDEL CORPORATION (NASDAQ : QDEL) Files An 8-K Departure of Directors or Certai..
02/21 QUIDEL CORP /DE/ : Change in Directors or Principal Officers, Financial Statemen..
02/16 QUIDEL : DE/ Management's Discussion and Analysis of Financial Condition and Res..
02/16 QUIDEL : Patent Issued for Device for Isolating an Analyte from a Sample, and Me..
02/15 QUIDEL : New flu-tracking app uses Maricopa County as beta site
More news
Sector news : Advanced Medical Equipment & Technology - NEC
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
01/31DJTHERMO FISHER SCIENTIFIC : Earnings, Sales Rise
01/31DJDANAHER : Revenue, Profit Rise
More sector news : Advanced Medical Equipment & Technology - NEC
News from SeekingAlpha
02/08 Quidel Corporation's (QDEL) CEO Doug Bryant on Q4 2016 Results - Earnings Cal..
02/08 Quidel beats by $0.07, misses on revenue
02/07 Notable earnings after Wednesday?s close
01/06 Quidel reports preliminary FQ4 revenue below estimates
2016 Quidel Corporation's (QDEL) CEO Doug Bryant on Q3 2016 Results - Earnings Cal..
Advertisement
Financials ($)
Sales 2017 219 M
EBIT 2017 26,9 M
Net income 2017 5,56 M
Debt 2017 8,99 M
Yield 2017 -
P/E ratio 2017 131,37
P/E ratio 2018 58,18
EV / Sales 2017 3,36x
EV / Sales 2018 3,12x
Capitalization 729 M
More Financials
Chart QUIDEL CORPORATION
Duration : Period :
Quidel Corporation Technical Analysis Chart | QDEL | US74838J1016 | 4-Traders
Full-screen chart
Technical analysis trends QUIDEL CORPORATION
Short TermMid-TermLong Term
TrendsBullishNeutralNeutral
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus HOLD
Number of Analysts 7
Average target price 22,7 $
Spread / Average Target 2,5%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
Douglas C. Bryant President, Chief Executive Officer & Director
Kenneth F. Buechler Chairman
Randall J. Steward Chief Financial Officer
John D. Tamerius Senior VP-Clinical & Regulatory Affairs
Timothy Tood Stenzel Chief Scientific Officer
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
QUIDEL CORPORATION3.22%729
THERMO FISHER SCIENTIF..9.60%60 370
DANAHER CORPORATION10.34%59 546
BOSTON SCIENTIFIC CORP..14.19%33 678
PHILIPS2.57%29 901
INTUITIVE SURGICAL, IN..20.55%28 076
More Results