quidel corp (QDEL) Key Developments
Quidel Corp. Provides Revenue Guidance for the Fourth Quarter and Year Ended December 31, 2014
Jan 12 15
Quidel Corp. provided revenue guidance for the fourth quarter and year ended December 31, 2014. For the quarter, the company expects revenues to be in the range of $63 million to $64 million.
For the full year 2014, revenues are expected to be in the range of $182 million to $183 million.
Quidel Corp. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-14-2015 11:30 AM
Jan 5 15
Quidel Corp. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-14-2015 11:30 AM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Douglas C. Bryant, Chief Executive Officer, President and Director, Randall J. Steward, Chief Financial Officer and Principal Accounting Officer.
Quidel Corp. Receives Simultaneous FDA Clearance and CLIA Waiver for Sofia(R) Strep A+ Fluorescent Immunoassay
Dec 17 14
Quidel Corporation announced that it has received marketing clearance and CLIA waiver by the United States Food and Drug Administration (FDA) for its Sofia Strep A+ Fluorescent Immunoassay (FIA) for the rapid detection of infections by Group A Streptococcus bacteria. These bacteria are the most common cause of bacterial pharyngitis and can also cause rheumatic fever and other potentially serious illnesses. Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia Strep A+ FIA combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure reliable, objective, highly accurate, diagnostic results within five (5) minutes of application of the patient's specimen. The linked-FDA clearance and CLIA waiver represent the first such achievement of any manufacturer under the FDA's new Dual Submission Program. This program requires a Pre-submission, and allows for simultaneous review of the 510(k) and CLIA waiver applications, substantially reducing the time and effort required for the FDA's review of 510(k) and CLIA waiver submissions that previously required two independent sequential submissions. Successful passage through the Dual Submission Program thus allows the diagnostic industry to pursue its commercial goals sooner, while also more quickly bringing new products to the marketplace where they can serve both physicians and patients. The CLIA waiver designation for the Sofia Strep A+ FIA allows Quidel to sell the assay to all CLIA categories of laboratories in the United States, including the CLIA-waived segment of the market that is comprised of approximately 30,000 physician offices laboratories and 5,000 hospital emergency departments. It is anticipated that the clearance and CLIA waiver of the Sofia Strep A + FIA will further expand the placement of new Sofia instruments a process that has accelerated throughout 2014.
Quidel Receives FDA Clearance for its AmpliVue(R) Hand-Held Molecular Diagnostic Test for Bordetella Pertussis
Dec 10 14
Quidel Corporation announced that it has received clearance from the United States Food and Drug Administration to market its AmpliVue Bordetella Assay for the detection of Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to Bordetella pertussis. The AmpliVue Bordetella Assay is an easy-to-use, self-contained, handheld disposable molecular diagnostic test with superb clinical accuracy. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 75 minutes. Like all FDA-cleared AmpliVue assays, the AmpliVue Bordetella Assay is CLIA-classified as moderately complex and does not require the customer to invest in expensive thermocycling equipment. This benefit, plus less laboratory space requirements, can significantly lower a laboratory's cost when adopting new molecular testing methods. Quidel's AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue Bordetella Assay expands to six the list of detectable analytes for which this novel AmpliVue platform now has FDA clearance. These include Pertussis, C. difficile, Group A Strep, Group B Strep, HSV1 and HSV2.
Quidel Seeks Acquisitions
Dec 1 14
Quidel Corp. (NasdaqGS:QDEL) is looking for acquisition opportunities. Quidel proposed underwritten public offering of $150 million and intends to use the net proceeds from this offering for working capital and other general corporate purposes, which may include acquisitions of products, technologies or businesses, and opportunistic repurchases of shares of its common stock.