Nodality, Inc. Receives CLIA Certification for its Clinical Laboratory
South San Francisco, California, June 28, 2012Nodality, Inc., a privately-held biotechnology company focused on improving the development and clinical use of therapeutics in cancer and autoimmune disease through the application of its proprietary Single Cell Network Profiling (SCNP) technology platform, today announced certification from the U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 for its clinical laboratory in South San Francisco, California. This certification follows achievement of a California State license in September 2011.
“Nodality has pursued the highest standards of operational performance from our inception, and that commitment to quality was evident in our clinical laboratory certification processes,” said Alessandra Cesano, M.D., Ph.D., chief medical officer and chief operating officer of Nodality. “CLIA certification is a critical step in the growth of our company as we develop SCNP-based products and assays, and prepare toward future commercialization.”
Mandated by the Code of Federal Regulations (CFR 42 Part 493.2), the CMS manage and conduct inspections of CLIA laboratories. The regulation was enacted to ensure consistent, accurate, and reliable clinical test results reporting from laboratories across the country used for the diagnosis, treatment, and/or prognosis of disease in human subjects. CLIA applies to all clinical laboratories operating in the U.S. and its territories and encompasses more than 200,000 clinical testing sites.
About NodalityNodality is a venture-backed, South San Francisco-based biotechnology company focused on improving the development and clinical use of therapeutics in cancer and autoimmune disease through the application of its proprietary Single Cell Network Profiling (SCNP) technology platform. Through its ability to functionally characterize cell signaling networks at the single cell level of resolution Nodality is committed to the biological characterization of individual patients to optimally match them with biologically-targeted treatments. SCNP is a novel technology licensed from Stanford University to characterize cell signalling networks in patients with cancer and autoimmune diseases. SCNP measures functional signaling network behavior at the level of the single cell, which provides insight into the presence and clinical meaning of functional cellular heterogeneity in otherwise molecularly and phenotypically homogeneous tissues, as well as allowing for the identification of rare cell subsets such as drug-resistant and stem cells. Nodality is utilizing SCNP in collaboration with drug developers to increase the efficiency of preclinical and clinical stages of drug development by decreasing the time, cost, and risks of the process. In February 2012, Nodality established its first multi-year pharma strategic collaboration with UCB Pharma S.A. (Euronext Brussels: UCB), utilizing its SCNP technology to assist the development of several UCB compounds focusing initially on immunology disorders.