ID Biomedical Corp. Receives FDA Clearance to Market Velogene TM Rapid MRSA Identification Assay
Velogene Rapid MRSA Test Quickly Identified Antibiotic Resistant "SUPERBUGS" To Help Improve Patient Care
July 14, 1999
Vancouver, B.C.
ID Biomedical Corporation (Nasdaq: IDBE, TSE: IDB) 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 ProbeTm 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 identifyi8ng 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), 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 NMSA
Identification Assay, ID Biomedical is currently developing the Velogene Rapid VRE Identification
Assay to detect another antibiotic resistant bacteria.
For more information, please contact:
Dean Linden
Manager of Corporate Communications