Monday March 1, 1:00 am Eastern Time
Company Press Release
SOURCE: ID Biomedical Corporation
ID Biomedical Files with FDA for Clearance to Market MRSA Test
VANCOUVER, March 1 /PRNewswire/ -- ID Biomedical Corporation (Nasdaq: IDBEF; Toronto: IBD; Berlin: IDB) announced today that it has filed a 510(k) application with the US Food and Drug Administration (FDA) for its Velogene(TM) Rapid MRSA Assay. The product is a rapid gene identification test for methicillin resistant Staphlococcus aureus (MRSA) from culture.
The application seeking clearance to market the Velogene(TM) Rapid MRSA Assay is based on the results of clinical trials at four US hospitals in which the test correctly identified 99.3 percent of samples when compared to conventional susceptibility tests and 100 percent when compared to results obtained by the gold standard gene identification technology, Polymerase Chain Reaction (PCR).
Clinical trials were conducted at four hospitals in the United States: the Columbia Presbyterian Medical Center, New York, NY; Los Angeles County/University of Southern California Medical Center, Los Angeles, CA; The Cleveland Clinic Foundation, Cleveland, OH; and Wishard Memorial Hospital, Indianapolis, IN.
The Velogene(TM) Rapid MRSA Assay is based on the Company's proprietary gene identification technology known as Cycling Probe Technology (CPT) and takes approximately 90 minutes after primary culture to identify the MecA gene, which is believed to be responsible for methicillin resistance. Rapid diagnosis means patients at risk may be treated more quickly and more accurately than is currently possible. Additionally, patients with antibiotic resistant strains can be isolated from other patients in the hospital.
MRSA and Staphylococcus aureus in general are common causes of hospital acquired infections including wound and post-surgical infections as well as life-threatening bloodstream infections. They spread quickly from patient to patient, which means rapid diagnosis, isolation and treatment are necessary to prevent outbreaks. Each year in the United States, two million patients acquire infections while hospitalized and, according to the Centers for Disease Control and Prevention, between 60,000 and 80,000 of them die. MRSA and Staphylococcus aureus are the most common cause of fatal infections.
Dr. Anthony Holler, President of ID Biomedical, said, ''The danger of antibiotic resistant bacteria has again been illustrated by a recent report from the US Centers for Disease Control that found the incidence of resistant bacteria in New York's major hospitals has more than doubled in recent years, leading to longer hospital stays and ultimately higher costs. Many hospitals are now recognizing that faster and more accurate detection of antibiotic resistant bacteria is necessary to combat this problem.''
ID Biomedical is also currently in preclinical development of a rapid test to identify another serious antibiotic resistant organism, vancomycin resistant Enterococcus (VRE). The Company intends to develop a line of products using the Velogene(TM) format as well as other diagnostic products based on the CPT platform.
ID Biomedical Corporation is a North American biotechnology company that is emerging as a leader in two fields of medicine: vaccines and rapid gene-based disease detection. The Company is engaged in the development of subunit vaccines against infectious diseases. The Company's lead products are a vaccine against group A streptococcus, which is the subject of a clinical partnership with the NIH, a vaccine for the prevention of tuberculosis which has been licensed to Pasteur Merieux Connaught, a member of the Rhone-Poulenc Group, and a therapeutic vaccine against HIV/AIDS, which is being developed in collaboration with the Albert Einstein College of Medicine in New York. |
