|29 SEPTEMBER 2016|
Life Length has received its certification as a clinical and diagnostic laboratory by the U.S. Federal Government and ISO 15189 accreditation, becoming the only lab in Europe to simultaneously possess both the U.S. and Europe’s highest regulatory approvals.
Life Length, world leader in telomere measurement, has been certified by the Center for Medicare and Medicaid Services (CMS), the U.S. Government agency, responsible for overseeing clinical laboratory testing in the United States. Life Length has received CLIA license #99D2112462 and is the only laboratory in Spain so certified. CMS is an agency of the Health and Human Services (HHS) of the U.S. Federal Government.
Life Length further announced that it has been awarded the prestigious international ISO 15189 accreditation, recognized in more than 60 countries for quality diagnostic testing along with the Platinum Accreditation by the certifying body A2LA (American Association for Laboratory Accreditation) which conducted the inspection.
Life Length was already certified by the Spanish Government with the License of Sanitary Activity CS34966.
These licenses confirm that Life Length’s proprietary Telomere Analysis Technology® (TAT®) test is accredited for diagnostic use in clinical practice and meets the highest standards of accuracy, reproducibility and quality for use by physicians and pharma clients in all fields from preventive medicine to oncology.
Stephen J. Matlin, CEO of Life Length, noted “the awarding of these regulatory licenses demonstrates the maturity of the TAT test. While there are over 250,000 certified laboratories in the U.S.; Life Length is only the 44th laboratory outside the U.S. to achieve a CLIA Certificate of Accreditation and the only accredited lab in Spain. This reinforces the application of our telomere testing assay for clinical use as a biomarker of cellular health, for determining biological age and to measure the efficacy of life-style programs as well as in risk stratification and the early detection of chronic and age-related diseases from cardiovascular and metabolic diseases to cancer. This confirms that Life Length is unquestionably the global leader in this emerging field of life sciences.”
These licenses will help accelerate Life Length’s commercial expansion. Currently the company operates in over 35 countries in the European Union, Turkey, Japan, Indonesia, the GCC (Gulf Cooperation Council states) and North America including Mexico.
About Life Length
Originally a spin-off of the Spanish National Cancer Research Center, with the support of the Botín Foundation, Life Length offers a number of proprietary tests for measuring cellular senescence, a crucial biomarker for establishing biological age, for early detection of chronic diseases and for risk stratification. Life Length is the only company in the world able to measure telomeres individually at the chromosomal level with its Telomere Analysis Technology® (TAT®). Life Length provides its testing services to the pharmaceutical and related industries for drug and product R&D and clinical studies, as well as to physicians working in preventive and personalized medicine in patient care together in such fields as cardiology and oncology in which telomeres have been shown to make a significant contribution in disease development. Life Length is accredited by the U.S. Federal Government under CLIA as a clinical laboratory under the CLIA legislation and also holds the prestigious IS0 15189 accreditation. For more information, please visit www.lifelength.com.