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Wednesday July 14, 8:59 am Eastern Time Company Press Release SOURCE: ID Biomedical Corporation ID Biomedical Receives FDA Clearance to Market Velogene(TM) Rapid MRSA Identification Assay Velogene Rapid MRSA Test Quickly Identifies Antibiotic resistant 'SUPERBUGS' to Help Improve Patient Care VANCOUVER, British Columbia, July 14 /PRNewswire/ -- ID Biomedical Corporation (Nasdaq: IDBE - news; Toronto: IDB - news) announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company's Velogene Rapid MRSA Identification Assay for marketing. The Velogene Rapid MRSA Identification Assay is a diagnostic test enabling the rapid and accurate identification of methicillin resistant Staphylococcus aureus (MRSA). MRSA is the most common cause of hospital-based ''superbugs,'' antibiotic resistant staph infections which can cause a range of illnesses, including wound and post-surgical infections, as well as life-threatening blood stream infections and pneumonia. MRSA infections are associated with longer hospital stays, in some cases averaging up to twelve days, and on average increase hospital costs per patient by $5,100, according to the National Foundation for Infectious Diseases. These infections can spread quickly among patients, which means rapid diagnosis, isolation and treatment are necessary to prevent serious outbreaks. Utilizing ID Biomedical's proprietary Cycling Probe(TM) Technology, the Velogene Rapid MRSA Identification Assay identifies the mecA gene responsible for methicillin antibiotic resistance in approximately 90 minutes after a primary culture. This response time represents a significant improvement as compared to the 24-48 hours (after culture) required by the current leading test. In a clinical trial at four U.S. hospitals last year, the Velogene Rapid MRSA Identification Assay correctly identified 99.3 per cent of samples when compared to conventional susceptibility tests and 100 percent when compared to Polymerase Chain Reaction, the current gold standard gene identification technology. ''This FDA clearance is a major milestone for ID Biomedical. It marks the culmination of years of research and development and gives us the opportunity to generate operating revenues this year for the first time in the Company's history,'' stated Anthony Holler, M.D., President of ID Biomedical. ''This clearance also validates our Cycling Probe(TM) Technology as an effective method of gene detection and positions our Velogene platform as a fast, accurate and easy to use method to identify a wide range of disease causing organisms. We are confident that our test will be well accepted and help hospitals quickly diagnose MRSA, improving patient care and reducing healthcare costs.'' Each year approximately two million patients in the United States acquire infections while hospitalized according to the Centers for Disease Control and Prevention. Methicillin is the antibiotic of choice in combating staph infections, but according to the National Foundation for Infectious Diseases, up to 40 percent of staph-based infections in large hospitals and between 25 to 30 percent of such infections in smaller hospitals are resistant to methicillin. Currently, MRSA infections can only be treated with the antibiotic vancomycin; however, evidence suggests that bacterial resistance -- including resistance to methicillin and vancomycin -- may be on the rise due to overuse and/or inappropriate use of antibiotics. ''Given growing concerns surrounding antibiotic resistance, and in particular, the emergence of 'superbugs,' the ability to quickly and accurately identify an infection has tremendous potential to positively impact public health,'' said Dr. Geri S. Hall, Staff Microbiologist at Cleveland Clinic Foundation and a principal investigator of the Velogene MRSA Assay. ''By reducing the length of time needed for identifying resistance by up to two days, the Velogene test gives the physician a tool that may help reduce the overuse of vancomycin while ensuring that the patient promptly receives the best care possible.'' ID Biomedical will be working with their international marketing and distribution partner, Alexon-Trend, a subsidiary of Sybron International (NYSE: SYB - news), to begin sales and shipment of the Velogene Rapid MRSA Assay by the end of the third quarter, 1999. The test is intended for use in hospital laboratories which currently conduct an estimated 4.6 million tests for MRSA in the U.S. each year. ''The Velogene test represents an excellent marketing opportunity for Alexon-Trend and is highly complimentary to our broad portfolio of rapid diagnostic products for infectious diseases,'' commented Alexon-Trend President, David Taus. ''Based on recent feedback from delegates at the American Society of Microbiology's annual June meeting in Chicago, we believe there is already great interest in this product.'' The Velogene Rapid MRSA Identification Assay is based on ID Biomedical's proprietary gene identification technology known as Cycling Probe(TM) Technology (CPT). CPT enables the detection and quantification of specific gene sequences and has potential applications for the rapid and accurate diagnosis of infectious diseases, genetic diseases and cancer diagnostics. The Company is also developing a rapid test to identify another serious antibiotic resistant organism, vancomycin resistant enterococcus (VRE). ID Biomedical Corporation is an emerging leader in two medical product areas: vaccines and rapid gene-based disease detection tests. The Company is engaged in the development of subunit vaccines against infectious diseases. The Company's lead product candidates are: a vaccine against group A streptococcus, which is the subject of a clinical partnership with the National Institutes of Health; a vaccine for the prevention of tuberculosis which has been licensed to Pasteur Merieux Connaught, a member company of Aventis (formerly Hoechst/Rhone-Poulenc); and a therapeutic vaccine against HIV/AIDS, being developed in collaboration with a senior professor at the Albert Einstein College of Medicine in New York. The Company is also developing its proprietary gene detection system, Cycling Probe(TM) Technology (CPT), which has cost, time and ease of use advantages. Using CPT, ID Biomedical has developed a gene-based testing platform called Velogene for the rapid identification of disease-causing bacteria from culture. In addition to the FDA-cleared Velogene Rapid MRSA Identification Assay, ID Biomedical is currently developing the Velogene Rapid VRE Identification Assay to detect another antibiotic resistant bacteria. The foregoing information includes forward-looking statements concerning, among other things, management's plans and objectives for future corporate objectives, possible product launch and possible revenues. All such forward-looking statements are, by necessity, only estimates or expectations of future results and actual results achieved by the Company may differ materially from these statements due to a number of factors, including i) the Company's ability to successfully complete preclinical development and manufacturing and obtain timely regulatory approval, ii) decisions, and the timing of decisions, made by the health regulatory agencies regarding approval of the Company's products for human testing, iii) the willingness of other companies to enter into agreements, iv) acceptance by the Company's products in the market place and v) the continued availability of capital to finance our activities. The Company assumes no obligation to update these forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting such statements. Velogene is a registered trademark of ID Biomedical Corporation. SOURCE: ID Biomedical Corporation | ||||||||||||
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