July 12, 2013 ST. LOUIS - C2N Diagnostics (C2N) today announced that it has signed a collaborative research and a global, exclusive supplier agreement with Cambridge Isotope Laboratories, Inc (CIL). The partnership guarantees C2N’s future access to mass quantities of highly enriched stable isotopes at predictable prices. These stable isotopes are key reagents to C2N's platform of Stable Isotope Labeling Kinetic (SILK™)-based biomarkers. Such biomarkers are showing considerable promise to detect early Alzheimer’s pathology (i.e., well before the onset of clinical symptoms) as well as to measure treatment responsiveness in preclinical and clinical drug studies.
C2N gains a research partner in CIL that is the premier manufacturer in the world of stable isotopes used in clinical research and diagnostic applications. Under terms of the agreement, C2N receives from CIL an upfront payment, commercial milestone fees, future supply guarantees of stable isotopes at predictable prices, and large quantities of GMP-grade stable isotope (13C6) labeled leucine (L-Leucine). The L-Leucine will be used in future upcoming clinical validation studies involving C2N's SILK™-based tests. CIL also commits to making significant investment in its own infrastructure and manufacturing processes. This will ensure CIL's ability to meet the future demand of stable isotopes that will incorporate into C2N's tests
"We spent considerable time evaluating the options available to C2N for obtaining access to stable isotopes used in our SILK™ tests. The logistics of having adequate supply of these reagents to enable disease screening on large numbers of at-risk individuals are far from trivial. We concluded that CIL is the best-positioned company in the world to meet our future expected demands in terms of both material quantity and material quality," stated Dr. Joel B. Braunstein, C2N's CEO. "Stable isotopes are non-radioactive, perfectly safe for people to consume and to the environment, and offer great sensitivity for tracking the in vivo metabolism of proteins implicated in diseases like Alzheimer's. This makes them highly desirable diagnostic reagents. As we expand the use of our SILK™-based biomarkers beyond research services and into clinical diagnostic applications, CIL will be an instrumental partner to help us qualify our test kits and to produce L-Leucine under GMP scaled-up conditions."
Dr. Joel Bradley, CIL's CEO, commented, "By focusing on ways to diagnose and treat early Alzheimer's disease, C2N is tackling one of the most important challenges in modern medicine. The company is making encouraging progress toward its ultimate goal of offering a convenient screening test for early Alzheimer's that can be administered in the ambulatory setting. At CIL, we acknowledge the social and commercial impact of C2N's efforts. For this reason, CIL is privileged and delighted to assist C2N with its development activities and to become C2N's exclusive supplier of stable isotopes."
About Cambridge Isotope Laboratories, Inc
Cambridge Isotope Laboratories, Inc (www.isotope.com) is the premier supplier of stable isotopes for research applications in proteomics, genomics, molecular biology, metabolic research, clinical and diagnostic research and ultra trace environmental analysis. For over 30 years, CIL has provided over 15,000 different research compounds to its base of over 35,000 medical, pharmaceutical, academic and government customers. The Company has over 400 employees operating in laboratory facilities located in four countries – the United States, Canada, Germany and France. Central headquarters is located in Tewksbury, Massachusetts.
About C2N Diagnostics
C2N Diagnostics, LLC (www.c2ndiagnostics.com) formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s products include the SILK-Aβ®, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond AD, products are in development to target Parkinson’s disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, please contact firstname.lastname@example.org or call 1-877-C2N-DIAG (1-877-226-3424).