Advanced Precision Medicine, Inc. engages Global Specimen Solutions, Inc. to identify molecular diagnostics for commercial launch in U.S. CLIA labs
Charleston, South Carolina (PRWEB) November 09, 2015 -- Advanced Precision Medicine, Inc. (APM), a commercialization catalyst for molecular diagnostics, today announced that it has engaged the services of a specialty specimen management clinical research organization, Global Specimen Solutions, Inc. (GSS), to qualify innovative molecular diagnostics for inclusion in the Syner-G portfolio of molecular diagnostics. APM’s Syner-G portfolio of molecular diagnostics includes applications in oncology, autoimmunity, wellness, and pain management.
GSS will also assist in the development of bioinformatics applications to support each Syner-G application that meets APM’s standards for qualification through its CLIA commercial operation. Data generated through the efforts of this partnership will be used to support qualified applications for 510K and Premarket Approval (PMA) submission with the Food and Drug Administration (FDA).
Dean Sproles, President of Advanced Precision Medicine, Inc., commented, "With world-class expertise in collecting and managing specimens for research, and a strong understanding of the technology trends, regulatory environment and competitive situation, GSS is an well positioned to evaluate the best partners for success in our commercialization efforts. This will allow APM to focus on identifying the most appropriate launch strategy for each of our Syner-G applications."
Gerald J. Vardzel, Vice President of Corporate Development at Global Specimen Solutions, commented, "APM's ability to custom tailor its lab operation and sales and marketing engine to meet the specific needs of our partners is phenomenal. We look forward to providing APM insights on our understanding of technology trends, the regulatory environment, and will target innovative research that is most suited for entry into the U.S. clinical market."
Sawan Hurst, MS, Director at APM, added, "Collaborating with GSS in the U.S. augments our primary strategy to focus on technology ready for swift market entry."
Amelia Warner, PharmD, RPh, CEO and Founder of GSS, commented, "We are extremely excited about collaborating with APM on this promising partnership. GSS is looking forward to building a long-term relationship with APM to help introduce disruptive technology into the clinic where we hope to impact current patient care."
About Global Specimen Solutions, Inc. (GSS)
GSS is a clinical research organization that specializes in integrated specimen management. The Company provides GCP compliant products that integrate proprietary informatics, world-class clinical trial management and operational expertise for human specimen research across the pharmaceutical and diagnostic sectors. GSS reduces the time, cost, and risk of specimen collection and analysis, enabling rapid translational approaches that will result in precision medicine for patients globally.
http://www.globalspecimensolutions.com
About Advanced Precision Medicine, Inc. (APM)
APM is a commercialization catalyst for innovation developed through the United States Precision Medicine Initiative. APM intends to become the leader in integrated healthcare information solutions by providing best-in-class clinical products supported by robust analytics. APM’s mission is to revolutionize traditional medical practice through the application of a broad based suite of molecular diagnostic tests.
http://www.advancedprecisionmedicine.com
Dean Sproles, Advanced Precision Medicine, Inc., http://www.advancedprecisionmedicine.com, +1 (503) 490-7417, [email protected]
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