We are the first CRO to complete GLP validation on Simoa HD-1 Analyzer for Biomarker Analysis
Frontage Laboratories, Inc., a Contract Research Organization based in Pennsylvania, New Jersey and China, today announced that they are the first CRO to complete a GLP validation of the Simoa HD-1 Analyzer and software along with the interface to Watson LIMS. Data will be generated, processed and stored in a secure environment meeting the compliance requirements needed to support biomarker analysis for regulated studies.
In February 2016, Frontage became Quanterix’ Preferred Partner in biomarker assay development and testing services in the regulated space. Validation entailed assessing the system against both business and regulatory requirements, including 21 CFR Part 11, working with Quanterix on how to best use the available features in a regulated environment, developing specific user requirements and test scripts, and successfully executing the validation test scripts. The Simoa software application includes compliance features such as audit trails, controlled user access, configurable security roles, a secure data base and a Simoa Desktop Shield add-on which limits a users’ ability to access workstation files.
“This is another important milestone for our partnership with Frontage and reinforces both parties’ commitment to ensuring compliancy with regulatory standards for biomarker analysis,” said Kevin Hrusovsky, CEO and Executive Chairman at Quanterix. “In collaboration with Frontage, we look forward to providing organizations with the tools and support necessary to better determine the efficacy of disease treatment, ultimately supporting meaningful advancements in precision medicine.”
"We are excited to announce that the Quanterix Simoa HD-1 Analyzer and software are now fully validated in Frontage, which allows the biomarker analysis to support drug discovery and development not only in an exploratory manner, but also in the regulated environment. We are happy to be one of the preferred partners of Quanterix by incorporating Simoa’s ultrasensitive single molecule measurement into our platforms of biomarker services, which allows us to meet the biomarker services needs of our sponsors," said Dr. John Lin, Senior Vice President, Bioanalytical and Biologics Services, Frontage Laboratories, Inc.
Quanterix is a developer of groundbreaking tools in high definition diagnostics. Its Simoa platform uses single molecule measurements to access previously undetectable proteins. With this unprecedented sensitivity and full automation, Simoa offers significant benefits to both research and clinical testing applications. Quanterix was established in 2007 and is located in Lexington, Massachusetts. To learn more about Quanterix and Simoa, please visit: www.quanterix.com. Investors can access a webcast of Kevin Hrusovsky’s recent JPMorgan presentation at: http://info.quanterix.com/watch-quanterix-jp-morgan-healthcare-presentation.