quidel corp (QDEL) Key Developments
Quidel Corporation Receives FDA Clearance for its Amplivue Trichomonas Assay
Mar 17 15
Quidel Corporation announced that it has received clearance from the United States Food and Drug Administration (FDA) to market its AmpliVue Trichomonas Assay for the detection of nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic female patients. This molecular assay aids in the diagnosis of trichomoniasis, a sexually transmitted disease attributable to infection by the Trichomonas vaginalis parasite. The AmpliVue Trichomonas Assay is an easy-to-use, self-contained, handheld disposable molecular diagnostic test with superb clinical accuracy and with procedural steps consistent with those commonly seen in moderately complex laboratories. Quidel's AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue Trichomonas Assay is Quidel's sixth molecular infectious disease assay to receive 510(k) clearance from the FDA in this hand-held, disposable AmpliVue format. In addition to Trichomonas Quidel offers 510(k)-cleared, in vitro diagnostic products on this novel platform for the diagnosis of six other pathogens: C. difficile, Group A Strep, Group B Strep, Pertussis, HSV1 and HSV2.
Quidel Corp. Approves Amendments to the Bylaws
Feb 27 15
On February 24, 2015, the board of directors of Quidel Corporation amended and restated the company's bylaws to add as a new Article VII a forum selection provision identifying Delaware as the exclusive forum for the adjudication of certain intra-corporate disputes. The adoption of the forum selection provision is effective as of February 24, 2015.
Quidel Corp. Presents at Barclays Global Healthcare Conference, Mar-12-2015 02:05 PM
Feb 24 15
Quidel Corp. Presents at Barclays Global Healthcare Conference, Mar-12-2015 02:05 PM. Venue: Loews Miami Beach Hotel, 1601 Collins Avenue, Miami, Florida, United States. Speakers: Douglas C. Bryant, Chief Executive Officer, President and Director.
Quidel Corp. Presents at Cowen and Company 35th Annual Healthcare Conference, Mar-04-2015 11:20 AM
Feb 18 15
Quidel Corp. Presents at Cowen and Company 35th Annual Healthcare Conference, Mar-04-2015 11:20 AM. Venue: The Boston Marriott Copley Place, Boston, Massachusetts, United States. Speakers: Douglas C. Bryant, Chief Executive Officer, President and Director.
Quidel Corp. Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2014
Feb 11 15
Quidel Corp. reported unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2014. For the quarter, the company's total revenues were USD 63,597,000 compared to USD 50,170,000 a year ago. Operating income was USD 12,915,000 compared to USD 236,000 a year ago. Income before taxes was USD 12,095,000 compared to loss before taxes of USD 89,000 a year ago. Net income was USD 7,113,000 or USD 0.20 per diluted share compared to USD 1,139,000 or USD 0.03 per diluted share a year ago. Adjusted net income was USD 13,336,000 or USD 0.37 per diluted share compared to USD 6,963,000 or USD 0.20 per diluted share a year ago. The increase in Revenue was due to greater sales of Infectious Disease products in the fourth quarter of 2014.
For the year, the company's total revenues were USD 182,615,000 compared to USD 175,410,000 a year ago. Operating loss was USD 9,208,000 compared to operating income of USD 4,842,000 a year ago. Loss before taxes was USD 10,983,000 compared to income before taxes of USD 3,434,000 a year ago. Net loss was USD 7,074,000 or USD 0.21 per diluted share compared to net income of USD 7,390,000 or USD 0.21 per basic and diluted share a year ago. Adjusted net income was USD 12,342,000 or USD 0.35 per diluted share compared to USD 21,348,000 or USD 0.61 per diluted share a year ago.