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 its obligations under Federal and State regulatory requirements," said Dr. Danong Chen, President and CEO of Theranostics Health.
About Theranostics Health
Theranostics Health is a privately held company founded in 2006. Its core technology is the breakthrough Reverse Phase Protein Microarray (RPMA) combined with Laser Capture Microdissection (LCM). The technology measures the activity of a large number of biomarkers, enabling pharmaceutical companies to accurately profile their drug candidates to facilitate efficient and effective drug development. More importantly, it enables physicians to tailor optimized therapies to their patients based on the biomarker profile of each individual patient, providing safer and more effective therapies. The technology, invented by the company's co-founders Drs. Emanuel Petricoin and Lance Liotta, was first published by them in 2001, has been featured in over 50 peer- reviewed publications and 20 scientific presentations within the past 2 years, and was successfully used in NCI-sponsored clinical trials. The Company has received an exclusive license from the National Institutes of Health (NIH) to commercialize microdissection including LCM combined with protein analysis for cancer diagnostics and companion diagnostics and has signed a three-year master research collaboration with Duke University. Currently, Theranostics Health is working with 5 of the top 10 global pharmaceutical companies in their drug R&D efforts. For more information please email email@example.com or visit http://www.theranosticshealth.com.
|SOURCE Theranostics Health|
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