Key Developments: Quidel Corp (QDEL.O)

QDEL.O on Nasdaq

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Latest Key Developments (Source: Significant Developments)

Quidel receives FDA clearance for Hand-Held Molecular Diagnostic Test for Group A Strep
Monday, 28 Jul 2014 09:00am EDT 

Quidel Corp:Receives clearance from United States Food and Drug Administration (FDA).To market AmpliVue GAS Assay for qualitative detection of Group A -hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat.AmpliVue GAS Assay is an easy-to-use, handheld disposable molecular diagnostic test that has superb clinical accuracy and does not require culture confirmation of negative results.Assay requires no upfront extraction of DNA and generates an accurate result in less than one hour.Like other previously FDA-cleared AmpliVue assays, AmpliVue GAS Assay does not require the customer to invest in either expensive thermocycling equipment, or any other upfront testing costs.Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain molecular testing methods.Group A streptococci are Gram-positive bacteria, primarily residing in nose, throat and skin; they are responsible for several illnesses, ranging from mild illnesses (strep throat or skin infections) to severe illnesses (necrotizing fasciitis, or streptococcal toxic shock syndrome).Strep throat, or streptococcal pharyngitis, is common illness from Group A streptococcal infections.These bacteria are spread through contact with airborne droplets from an infected person's cough, sneeze or via contaminated items such as eating utensils.  Full Article

Quidel Corp receives FDA Clearance for its Lyra Molecular PCR assay for the Detection of infections from Pyogenic Streptococcus Group A and C or G
Tuesday, 22 Apr 2014 02:30pm EDT 

Quidel Corp:Says it has received clearance, via the De Novo Request process, from the USFDA to market its Lyra Direct Strep Assay, a multiplex real-time PCR assay.This new molecular test detects and differentiates between pyogenic Group A and pyogenic C or G Streptococcal throat infections.  Full Article

Quidel Corp gives FY 2015 revenue guidance above estimates - Conference call
Monday, 3 Mar 2014 04:10pm EST 

Quidel Corp:Expects fiscal 2015 revenues up to about $250 mln.Fiscal 2015 revenue estimate $227 mln - Thomson Reuters I/B/E/S.  Full Article

Quidel Corp gives Q4 2013 revenue guidance in line with analysts' estimates
Wednesday, 8 Jan 2014 04:15pm EST 

Quidel Corp:Says Q4 2013 revenues to be about $50 million.Q4 2013 revenue of $49 million - Thomson Reuters I/B/E/S Estimates.  Full Article

Quidel Corp receives FDA clearance for its hand-held molecular diagnostic test
Monday, 30 Dec 2013 04:05pm EST 

Quidel Corp:Says it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its AmpliVue Group B Strep Assay.Says AmpliVue is Quidel's non-instrumented molecular diagnostic test that employs a novel amplification technology with an easy-to-use, hand-held device.Says AmpliVue Group B Strep Assay combines isothermal Helicase Dependent Amplification with Quidel's well-established expertise in lateral flow technology to detect Group B Streptococcus from enriched broth cultures of specimens from antepartum women.  Full Article

Quidel Corp Receives FDA Clearance for Sofia hCG Fluorescent Immunoassay (FIA)-DJ
Monday, 5 Aug 2013 06:00pm EDT 

Dow Jones reported that Quidel Corporation received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer for the rapid, objective detection of elevated levels of human chorionic gonadotropin ( hCG), an early indicator of pregnancy. The 510(k) clearance allows Quidel to market and sell its new Sofia hCG FIA in the United States.  Full Article

Quidel Corp Completes Acquisition Of BioHelix Corporation
Monday, 6 May 2013 04:05pm EDT 

Quidel Corp announced that it completed the acquisition of BioHelix Corporation (BioHelix). According to the terms of the deal, Quidel will pay BioHelix shareholders $10 million in cash, plus additional amounts in connection with an R&D earn-out based on the completion of a designated number of assays and a commercial earn-out dependent on product sales over a defined period.  Full Article

Quidel Corp Completes Acquisition Of BioHelix Corporation
Monday, 6 May 2013 04:05pm EDT 

Quidel Corp announced that it completed the acquisition of BioHelix Corporation (BioHelix). According to the terms of the deal, Quidel will pay BioHelix shareholders $10 million in cash, plus additional amounts in connection with an R&D earn-out based on the completion of a designated number of assays and a commercial earn-out dependent on product sales over a defined period.  Full Article

Quidel Corp Receive FDA Clearance For Clostridium Difficile Assay And Quantstudio DX And 7500 Fast DX Real-Time PCR Instruments
Monday, 18 Mar 2013 08:00am EDT 

Quidel Corp announced that they received 510(k) clearances from the United States Food and Drug Administration (FDA) to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments. Clostridium difficile bacterial infections are life-threatening, especially for the elderly, immunocompromised populations, and for patients on a prolonged antibiotic regimen. C. difficile infection (CDI) is frequently associated with antibiotic therapy and extended hospital stays. This Quidel Molecular Direct C. difficile Assay is part of Quidel's expanding line of molecular diagnostics products. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories, including Life Technologies' QuantStudio Dx and 7500 Fast Dx. These reagents provide attractive features that include refrigerated storage instead of freezing, convenient ready-to-use reagents, a short time to result, and other benefits that favorably enhance the molecular workflow. The current 510(k) clearance represents another milestone in the extension of Life Technologies' move into the diagnostics arena. In September 2012, Life Technologies launched Pervenio Lung RS, a lab-developed test distinguishing high-risk from low-risk early stage lung cancer patients. In February 2013, the company received 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore(R) HLA typing kits.  Full Article

Quidel Corp Issues Q4 2012 Revenue Guidance Above Analysts' Estimates
Friday, 4 Jan 2013 09:15am EST 

Quidel Corp announced that for the fourth quarter of 2012, it expects revenues in the range of $53 to $54 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $44 million for the fourth quarter of 2012.  Full Article

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