The partnership will include running clinical sample cohorts in both locations to demonstrate the precision, sensitivity, and reproducibility of the assays. Nuclea will incorporate these new assays into its CLIA lab in Cambridge.
Dr. Benoit Coulombe, a principal investigator at the IRCM, is involved in the development and application of mass spectrometry-based workflows in translational proteomics from biomarker discovery to validation. Nuclea focuses on diagnostic development and validation with a recent emphasis placed on mass spectrometry based assays.
Detecting and quantifying insulin and its therapeutic analogs is important for medical, sports doping, and forensic applications. New mass spectrometry-based assays have demonstrated a high degree of reliability and robustness, which is important for treatment decisions and response to therapy in type 2 diabetes.
“Mass spectrometry-based assays for key protein targets have reached a tipping point where they can now become routine in clinical laboratories. Nuclea’s high quality manufacturing and service capabilities combined with the new high resolution mass spectrometry will provide urgently needed tests in the very important type 2 diabetes space,” said Mary Lopez, COO and VP of Proteomic Discovery at Nuclea Biotechnologies.
“We are enthusiastic to partner with Nuclea on this project. Validation of these assays across two different laboratories will demonstrate high value for this new technology in clinical and research environments,” said Dr. Coulombe, Director of the Translational Proteomics research unit and the Proteomics Discovery Platform at the IRCM. “
Nuclea has been working in the metabolic disease space for many years,” said Patrick Muraca, President and CEO of Nuclea Biotechnologies. “This partnership with the IRCM will provide Nuclea with inestimable expertise to offer a great deal of clinical value in the treatment and management of type 2 diabetes. This is an important area of focus in the U.S. and Canada because 35% of U.S. adults and 20% of Canadian adults have metabolic syndrome. ”
“The IRCM is pleased with this partnership, which recognizes the importance of Dr. Coulombe’s outstanding work in the field of biomarkers,” added Dr. Tarik Möröy, IRCM President and Scientific Director. “The development of new biomarkers in the context of precision medicine is of great interest to the IRCM, as they are proving very useful for diagnosis and for the development of new drugs. Thanks to this technology, it will be possible to evaluate a patient’s response to treatment and, as a result, will lead to improved healthcare.”
The results of the validation study will be published in 2016.