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Theranostics Health Receives Green Light to Perform Clinical Testing
Date:9/15/2008

ROCKVILLE, Md., Sept. 15 /PRNewswire/ -- Theranostics Health (TH) today announced that it has received a CLIA Certificate of Registration from the Federal Government. This, along with its Medical Laboratory Permit from the State of Maryland Department of Health & Mental Hygiene, allows the Company to perform clinical diagnostic laboratory testing in the disciplines/specialties of Immunology/protein microarray and Pathology/histopathology.

The Clinical Laboratory Improvement Amendments (CLIA), passed in 1988, established quality standards for the accuracy, reliability, and timeliness of patient laboratory test results. The Federal Government's Centers for Medicare and Medicaid Services (CMS), under the umbrella of the Department of Health and Human Services (HHS), is responsible for management of the CLIA program. According to HHS, a facility is considered a laboratory under CLIA if it performs even one test on, "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings." TH is now compliant with and certified by CLIA Quality Systems laboratory regulations.

Under the Code of Maryland Regulations, a state license is necessary to perform clinical laboratory tests in Maryland. Licensure involves requisite permit applications and fees as well as compliance with quality assurance, quality control, proficiency testing and personnel requirements.

"This represents another significant milestone for our young company in terms of building our capabilities. It allows us to expand the scope of services that we provide to our clients and collaborative projects that we conduct with our partners. It also allows us to accelerate the launch of our suite of clinical theranostic tests for personalized therapy. Theranostics Health will continue to meet the highest standards of clinical laboratory testing, including
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SOURCE Theranostics Health
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