Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
PRNewswire - December 17, 2001
The test, TRUGENE (TM) HIV-1 Genotyping Test, is manufactured by Visible Genetics Inc. (VGI) and is the only test of its kind to be reviewed and cleared for sale by the U.S. Food and Drug Administration (FDA).
Dynacare will be offering the test throughout its integrated network of regional laboratory operations in 21 states in the U.S. Dynacare operates 22 central labs, including Dynagene, its center for genetic and esoteric testing and counseling, as well as 63 rapid response labs and 173 patient service centers.
HIV genotyping is used to identify specific mutations of the virus that can lead to drug resistance in an infected patient. Using the TRUGENE(TM) HIV-1 genotyping report, doctors are alerted to the presence of specific viral mutations in the patient and advised on a more appropriate drug therapy program for that patient. Successful therapy results in a reduction in the amount of HIV in the infected patient (the "viral load"), thereby minimizing the damaging effects of HIV.
"Four different clinical studies conducted over the past two years have shown that the management of an HIV-infected patient is greatly improved when HIV genotyping is used to assist in drug selection," said Joel Goodman, Ph.D., chief scientific officer at Dynacare.
"Initial HIV drug therapy has failed in over 60 percent of patients worldwide who are under active antiretroviral drug treatment," said John Stansell, M.D., acting chief and medical director, Positive Health Program, University of California at San Francisco. "TRUGENE offers physicians the opportunity to prescribe drugs, which will enable them to re-establish control of their patients' HIV thereby improving their quality of life."
Harvey Shapiro, president and chief executive officer of Dynacare, said, "Dynacare is continuing to expand its test menu with advanced technologies to help physicians provide the best care possible to their patients. We are becoming the lab provider of choice in several key clinical areas, which includes infectious disease testing. The addition of TRUGENE helps round out our program and reconfirms our position as a leader in the industry. We are proud to link with Visible Genetics in offering this outstanding new test."
Richard T. Daly, president and chief executive officer of Visible Genetics, added, "Dynacare is the third largest clinical lab company in North America and we are very pleased that they selected our TRUGENE HIV-1 Genotyping Test after evaluating different options. Dynacare's use of our product typifies the growing adoption of our system to provide HIV drug resistance testing at the local level based on our improved turnaround time, FDA clearance and easy-to-use report."
According to the World Health Organization, there are approximately 940,000 people in North America who are infected with HIV, and more than 40 million worldwide.
About Dynacare
Through its integrated network of regional laboratory operations, Dynacare provides innovative and trusted clinical laboratory services to its clients, their patients and professional partners. Dynacare provides laboratory services in 21 U.S. states and is a leading provider of laboratory services in Canada. Dynacare's laboratory partners include: University Health System, Inc. in Knoxville, TN (the University of Tennessee Medical Center), Froedtert Health System, Inc. in Milwaukee, WI, and Allegheny General Hospital, a member of the West Penn Allegheny Health System in Pittsburgh, PA. Further information about Dynacare can be obtained from the Company's web site at http://www.dynacare.com .
Launched in November of 2000, Dynagene, Dynacare's Center of Excellence for Genetic and Esoteric Testing and Counseling, performs genetic reference work and other esoteric testing for all Dynacare laboratories, as well as referring physicians, and independent laboratories throughout North America. Dynagene provides a full range of genetic services including prenatal, postnatal, and cancer cytogenetics, FISH testing, molecular genetics, and genetic counseling. Further information on Dynagene can be found on the Company's web site at http://www.dynagene.com .
About Visible Genetics
Visible Genetics Inc. is an international leader in the emerging field of pharmacogenomics, which uses genetic information in the identification and analysis of genes to improve patient care and reduce healthcare costs. VGI manufactures and markets high performance automated DNA sequencing systems and complete kits for the analysis of genes linked to disease. The Company's OpenGene(TM) system employs patented CLIP technology -- a single-step, bi-directional sequencing method that significantly reduces the time and cost involved in identifying clinically relevant genetic information. Visible Genetics has its corporate headquarters in Toronto, Canada; its main production facility in Atlanta, USA; its European headquarters in High Wycombe, UK, its research base in Cambridge, UK, operating companies in France, Spain, Italy, Germany, Portugal, Switzerland, Israel and Australia, and is represented in 10 additional countries around the world. The company employs approximately 350 people worldwide.
For Dynacare Investors
This press release may contain "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934. When used in this press release, the words "may," "could," "should," "would," "believe," "anticipate," "estimate," "expect," "intend," "plan" and similar expressions or statements regarding future periods are intended to identify forward-looking statements. All forward-looking statements are inherently uncertain as they are based on various expectations and assumptions concerning future events, which by their nature involve substantial risks and uncertainties beyond Dynacare Inc.'s control. Dynacare Inc. undertakes no obligation to update or revise any forward-looking statement for events or circumstances after the date on which such statement is made. Dynacare Inc. cannot assess the impact of or the extent to which any single factor or risk, or combination of them, may cause actual results to differ materially from those contained in any forward-looking statements. For a more complete discussion of risk factors, please see Dynacare Inc.'s filings with the Securities and Exchange Commission, including its Registration Statement on Form S-1 filed on October 26, 2001 and its Annual Report on Form 10-K for the year ended December 31, 2000.
For Visible Genetics Investors
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks, uncertainties and other factors which may cause the Company's results to differ materially from expectations. These include risks relating to our ability to obtain market acceptance of genotyping and the Company's products, delays in, or the refusal of, insurance companies and other third-party payors to reimburse us for our products, delays in product development, our ability to acquire and protect intellectual property important to our business through patents, licenses or other arrangements, claims that our intellectual property may interfere with the rights of others, ability to obtain regulatory approvals, delays in making the new Atlanta manufacturing facility operational, and other risks as detailed from time to time in the Company's SEC filings, including its most recent Annual Report on Form 20-F. These forward-looking statements speak only as of the date hereof. VGI disclaims any intent or obligation to update these forward-looking statements.
SOURCE Dynacare Inc. Web Site: http://www.dynagene.com http://www.dynacare.com
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