Key Developments: Quidel Corp (QDEL.O)
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18 Jun 2013
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Latest Key Developments (Source: Significant Developments)
Quidel Corp Completes Acquisition Of BioHelix Corporation
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
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
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
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
Quidel Corp Receives FDA Clearance For Its AmpliVue Hand-Held Molecular Diagnostic Test For Clostridium Difficile
Quidel Corp announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel's non-instrumented molecular diagnostic test -- the AmpliVue C. difficile Assay -- for the detection of toxigenic Clostridium difficile bacterial DNA. Detection of the pathogen is achieved using a hand-held, fully contained cassette that combines isothermal Helicase Dependent Amplification (HDA) with its lateral flow detection technology. C. difficile infection is frequently associated with antibiotic therapy and prolonged hospital stays. Typical symptoms include nausea, fever, watery diarrhea and abdominal pain due to inflammation of the colon. Full Article
Quidel Corp Receives CE Mark For Sofia Legionella Fluorescent Immunoassay
Quidel Corp announced that it has received the CE Mark for Sofia Legionella FIA for use on the Sofia Analyzer for the rapid detection of Legionnaires' disease, also known as legionellosis. The CE Mark allows Quidel to launch new Sofia Legionella FIA in Europe. Full Article
Quidel Corp Receives CE Mark for Sofia RSV Fluorescent Immunoassay Test
Quidel Corp announced that it has received the CE Mark for its Sofia RSV Fluorescent Immunoassay (FIA) for use on the Sofia Analyzer for the rapid detection of respiratory syncytial virus (RSV). Sofia is the brand name for Quidel's immunoassay system that was launched earlier this year. The Sofia Analyzer and Sofia RSV FIA combine fluorescent chemistry, advanced lateral flow technology, and failure alert and fail-safe systems to ensure a reliable, objective, accurate, and rapid diagnostic result. The Sofia system was 510(k) cleared in October of 2011 and received Clinical Laboratory Improvement Amendments (CLIA) waiver by the U.S. FDA in April of 2012. With the CE Mark, Quidel is now launching its new Sofia RSV FIA in Europe. Full Article
Quidel Corp Secures New $140 Million Credit Facility
Quidel Corp announced that it entered into an amended and restated $140 million, five-year senior secured credit facility with a group of banks, led by Bank of America, N.A. as the sole lead arranger, and U.S. Bank National Association as the syndication agent. The funds borrowed under the credit facility are expected to be used by Quidel for general corporate purposes and/or acquisitions. The new senior credit facility replaces and expands upon Quidel's previous $120 million credit facility that was expiring in October of 2013. The new facility provides Quidel with the option, under certain conditions, to increase the company's borrowing capacity. The credit agreement includes customary covenants and events of default. Full Article
Quidel Corp Receives CE Mark for Direct Specimen Rapid PCR Test for Toxigenic Clostridium Difficile
Quidel Corp announced that it received CE mark for the Quidel Molecular Direct C. difficile Tox A/B assay for the detection of toxigenic Clostridium difficile bacterial DNA. C. difficile infection is frequently associated with antibiotic therapy and often causes diarrhea and inflammation of the colon. This Quidel Molecular Direct C. difficile Tox A/B 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 with their existing thermocyclers. These reagents provide attractive features that include refrigerated storage (no freezer required), convenient ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcome. Full Article
Quidel Corp Receives CE Mark for AmpliVue Hand-Held Molecular Diagnostic Test for Clostridium Difficile
Quidel Corp announced that it received CE mark for the AmpliVue C. difficile assay, its non-instrumented molecular test for the detection of toxigenic Clostridium difficile bacterial DNA. Detection of the pathogen is achieved using a hand-held fully contained detection cassette which utilizes lateral flow technology. C. difficile is frequently associated with antibiotic therapy and often causes diarrhea and inflammation of the colon. Full Article
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