SAN DIEGO--(BUSINESS WIRE)--Ignyta, Inc., the personalized medicine company dedicated to improving the diagnosis and treatment of patients with rheumatoid arthritis, lupus and other autoimmune diseases, announced today the appointment of Jerry Hurst, a veteran of CLIA lab operations and former manger of the state of California’s CLIA lab inspection program, to its Executive Advisory Board.
“With over 30 years of experience in clinical laboratory science, including as manager of the state of California’s CLIA inspection program, and his subsequent involvement in the establishment of multiple commercial CLIA labs, Jerry has an unmatched understanding of what is required to successfully develop and operate a CLIA lab.”
“As Ignyta prepares to establish a leading CLIA lab to perform diagnostic services for autoimmune disease, we are assembling a team with proven track records in successful laboratory development, licensure and operations,” said Jonathan Lim, M.D., co-founder, chairman and CEO of Ignyta. “With over 30 years of experience in clinical laboratory science, including as manager of the state of California’s CLIA inspection program, and his subsequent involvement in the establishment of multiple commercial CLIA labs, Jerry has an unmatched understanding of what is required to successfully develop and operate a CLIA lab.”
“I am passionate about bringing to bear my experience from many years managing the California CLIA inspection program to help innovative diagnostic companies establish high performing CLIA labs that comply with all state and federal regulations,” said Mr. Hurst. “Ignyta has a very promising technology platform and approach that has potential to provide meaningful benefit, through early disease detection, to patients suffering from autoimmune disease.”
Jerry Hurst is a certified public health microbiologist who has worked as a licensed Clinical Laboratory Scientist in all specialties (e.g., hematology, chemistry, immunohematology, microbiology, toxicology, immunology). He worked in the California laboratory regulatory agency (Laboratory Field Services) as an inspector, eventually managing the California and federal CLIA inspection programs statewide, the HIV approval program, the Examiner training program, and the laboratory complaint program. Subsequent work in the private sector included Administrative Laboratory Director of Hayward and Fremont Kaiser Hospitals, Vice President for Regulatory Affairs at Unilab Corporation, and Laboratory Director of the Humboldt and Fresno Public Health Laboratories.
He currently assists laboratories and organizations seeking new clinical laboratory licensure, CLIA certification, and/or accreditation. This work includes developing applicable validation studies for Laboratory Developed Tests, establishing and implementing required infrastructure along with applicable procedures, and assisting in the development of appropriate corrective action plans to address federal/state citations. National and international clients include large and small clinical laboratories, biotechnology companies, state and county public health laboratories, private attorneys, the U.S. Department of Justice, and research laboratories.
About Ignyta, Inc.
Ignyta, Inc., located in San Diego, California, is a personalized medicine company developing revolutionary new products and services to customize diagnosis and treatment of patients with rheumatoid arthritis, lupus and other autoimmune diseases.
The company was launched in August 2011 by Jonathan E. Lim, M.D., former president, CEO, and board director of Halozyme Therapeutics, Inc., and Gary S. Firestein, M.D., director of the Clinical and Translational Research Institute and Dean and Associate Vice Chancellor of Translational Medicine at UC San Diego. Ignyta is a trailblazer in the application of “omics” technologies integrated with bioinformatics to the development and commercialization of novel biomarkers and tests for diagnostic and therapeutic applications in autoimmune diseases.
The scientific discoveries that fueled the founding of Ignyta were published in July 2012 in the Annals of the Rheumatic Diseases (http://bit.ly/QOZ8Zr). In 2012, the company successfully closed a $5.5 million Series B financing led by City Hill Ventures, LLC (http://www.cityhillventures.com/) and Colt Ventures (http://www.coltventures.com/), and a $500,000 capital term loan from Silicon Valley Bank (http://www.svb.com/). For more information, please visit: www.ignyta.com.