Diagnostic company and Stable Isotope manufacturer form biomarker alliance

Written by Phoebe Heseltine, Future Science Group

Neurodegenerative disease diagnostics company, C2N, forms research partnership with Cambridge Isotopes.

C2N Diagnostics (MO, USA) have recently announced the signing of a collaborative research agreement with Cambridge Isotope Laboratories, Inc. (CIL) (MA, USA). As a key reagent to C2N’s platform of Stable Isotope Labeling Kinetic (SILKTM)-based biomarkers, the partnership will ensure that C2N has access to large quantities of highly enriched stable isotopes at predictable prices.

As a global manufacturer of stable isotopes for clinical applications, CIL will provide C2N with an upfront payment, commercial milestone fees, and a guaranteed supply of stable isotopes. C2N will also acquire quantities of GMP-grade stable isotope (13C6)-labeled leucine, to be used in upcoming clinical validation studies of the SILK-based biomarkers.

According to Joel Braunstein, Chief Executive Officer of C2N, “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.” He continued, “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 labeled leucine under GMP scaled-up conditions.”

CIL is in the process of producing a convenient screening test for Alzheimer’s that can be administered in an ambulatory setting. Joel Bradley, Chief Executive Officer of CIL, said of the collaboration, “By focusing on ways to diagnose and treat early Alzheimer’s disease, C2N is tackling one of the most important challenges in modern medicine.” He continued, “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.”

Source: C2N Diagnostics press release: C2N Diagnostics announces collaborative research agreement with Cambridge Isotopes.