CHATSWORTH, Calif., Dec. 17, 2009 (GLOBE NEWSWIRE) -- IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that it has appointed David W. Gates, Ph.D., to the newly-created position of Vice President, Quality and Regulatory Affairs. Dr. Gates' primary focus will be the formulation and implementation of regulatory strategies for all company units, including Iris Diagnostics, Iris Molecular Diagnostics (IMD) and Iris Sample Processing (ISP) business units, as well as overseeing all U.S. and international regulatory filings, in support of the advancement of the Company's existing and emerging product pipeline.
"Dr. Gates brings to IRIS more than 20 years of extensive and highly technical experience in regulatory affairs, process transfer, compliance, quality management and operations in the medical device, in-vitro diagnostics and biotechnology industry," stated Cesar Garcia, Chairman, President and Chief Executive Officer of IRIS International. "His deep understanding of molecular diagnostics and in-vitro diagnostics in general, combined with his strong regulatory background and successful track record of leading regulatory submissions, reviews and clearances for many medical diagnostic products in the U.S. and abroad, will be of tremendous value and significantly solidifies our management team as we continue with the development and commercialization of our new product pipeline," added Mr. Garcia.
"The naming of Dr. Gates to this newly created position comes at a time when IRIS is embarking on an aggressive regulatory approval pathway related to our robust new product pipeline. Bringing the vital function of managing Regulatory Affairs in-house provides greater control and cost savings by alleviating the need for certain external regulatory consulting services which we are currently utilizing to formulate our regulatory strategies," Mr. Garcia said.
Prior to joining IRIS, since 2005, Dr. Gates was Director of Regulatory Affairs for Roche Molecular Systems, Inc., where he was responsible for FDA regulatory submissions including PMAs, 510(k)s and IDEs supporting various molecular diagnostic products, and managed numerous EU, Canadian, Japanese and Asian-Pacific registrations. Before that, he was Vice President of Regulatory Affairs/Quality Assurance and Control for ChemBio Diagnostic Systems, Inc., where he developed and submitted a PMA with the FDA for a rapid HIV assay and managed FDA inspections. From 2001 to 2004, he was with Metrigenix where he served as Vice President Quality Assurance and Regulatory Compliance, having established and instituted Design Control and complete Quality Systems, initiated and taught a GMP training program, and initiated, defined and monitored design and process validation for a unique micro array platform.
From 1997 to 2001, he was Director of Quality Management and Regulatory Compliance for Becton Dickinson Diagnostic Systems, Inc., where he managed a staff 120 associates and a budget of $12 million. Dr. Gates began his career in 1983 with Difco Laboratories, Inc., where for 14 years prior to being acquired by Becton Dickinson in 1997, he held various scientific and executive positions having gone from Senior Scientist in Viral Immunodiagnostics to Manager of Process Development to Manager of Regulatory Affairs and ultimately to Director of Regulatory Affairs.
Dr. Gates earned his doctorate in microbiology from the University of Tennessee, Knoxville, TN in 1981, and did his post doctoral fellowship in molecular/cellular biology at Stony Brook University, SUNY from 1981 - 1983.
About IRIS International, Inc.
IRIS International is a leading global in vitro diagnostics company focused on products that analyze particles and living cell forms and structures, or morphology of a variety of body fluids. The Company's products leverage its strengths in flow imaging technology, particle recognition and automation to bring efficiency to hospital and commercial laboratories. The initial applications for its technology have been in the urinalysis market and the Company is the leading worldwide provider of automated urine microscopy and chemistry systems, with an installed base of more than 2,400 systems in more than 50 countries. The Company is expanding its core imaging and morphology expertise into related markets and is developing applications in hematology and urinary tract infections. In addition, the Company is developing molecular diagnostic tests based on its Nucleic Acid Detection Immunoassay, or NADiA(R), platform, with applications in oncology and infectious disease. For more information visit www.proiris.com.