Key Developments For Quidel Corporation
Quidel Corporation (QDEL.O) (Nasdaq)
Quidel Corporation Comments On Q4 2009 Revenue Outlook-Conference Call
Quidel Corporation announced that it expects to achieve meaningful double-digit revenue growth in the fourth quarter of 2009. According to Reuters Estimates, analysts on an average are expecting the Company to report revenue of $34 million for the same period.
Quidel Corporation Announces Launch of Their MicroVue C5a EIA Kit for Research Use Only
Quidel Corporation announced the launch of their MicroVue C5a EIA Kit for Research Use Only. The test is not for use in diagnostic procedures; it is intended for use in the research environment.
Quidel Corporation Announces Joint Development And Commercialization Agreement With BioHelix Corporation
Quidel Corporation announced that it has entered into a joint development and commercialization agreement with BioHelix Corporation. The agreement with BioHelix focuses on the development and commercialization of in vitro molecular diagnostic tests utilizing BioHelix's isothermal amplification technology. The partnership combines BioHelix's expertise in the research and development of nucleic acid technologies for diagnostic applications with the Company's strength in the development, manufacture and commercialization of diagnostic tests. Under the partnership, the Company will fund and jointly develop with BioHelix assays for rapid detection of infectious pathogens in a non-instrumented, handheld format utilizing BioHelix's isothermal amplification technology. BioHelix undertakes primary responsibility for assay development while the Company has primary responsibility for manufacturing, marketing and selling the new products developed under the agreement and exclusive, worldwide commercialization rights for the new products.
Quidel Corporation Issues Clarification Regarding Special 510(k) Clearance To Add 2009 H1N1 Influenza A Virus Reactivity Information To QuickVue Influenza A+B Test Package Insert
Quidel Corporation announced that it has issued clarification regarding the Special 510(k) clearance for an update to the Company's QuickVue Influenza A+B test package insert. A news wire agency released misleading information stating there is a new swine flu version of Quidel Corporation's QuickVue Influenza A+B test and that FDA approved this new version. This statement is incorrect. Quidel did obtain Special 510(k) clearance for an update to the QuickVue Influenza A+B test package insert to include reactivity with culture isolates of the 2009 H1N1 Influenza A virus. Although the QuickVue Influenza A+B test has been shown to detect the 2009 influenza A (H1N1) virus, the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1) virus have not been established. The QuickVue Influenza A+B test kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes. Quidel Corporation clarified, the special 510(k) clearance was for an update to the package insert. The QuickVue Influenza A+B test can detect cultured isolates of the 2009 influenza A (H1N1) virus, however, the clinical performance with actual clinical specimens has not been demonstrated.
Quidel Corporation Obtains Special 510(k) Clearance To Add 2009 H1N1 Influenza A Virus Reactivity Information To QuickVue Influenza A+B Test Package Insert
Quidel Corporation announced that it has received Special 510(k) clearance for an update to the Company's QuickVue Influenza A+B test package insert to include reactivity with culture isolates of the 2009 H1N1 Influenza A virus. This clearance supplements the reactivity with 13 other isolates of seasonal H1N1 influenza viruses currently listed in the package insert. In total, 34 different isolates of human Influenza A, 13 different isolates of human Influenza B, and 24 different isolates from birds and mammals have now been shown to be detectable by the QuickVue Influenza A+B test.
