Flagship Biosciences establishes a Quality Management System (QMS) for the development of medical device software to bring image analysis based Companion Diagnostics (CDx) into the clinical market.
Westminster, CO – October 27, 2015 – Flagship Biosciences’ Software Development Department has established a Quality Management System (QMS) for the development of medical device software in compliance with ISO13485, ISO14971, IEC62304 and FDA 21 CFR Part 820 QSR. This critical milestone is necessary to manufacture medical device software for Companion Diagnostics (CDx) applications.
Flagship’s proprietary tIA (Tissue Image Analysis) toolbox and slide analysis system TALIS™ (Tissue Analysis Laboratory Information System) are currently used in an exploratory setting to prove the clinical utility of fit-for-purpose image analysis based CDx. With the implementation of the QMS, Flagship can now take these specific image analysis applications from the exploratory settings and seamlessly develop the medical device software required for full implementation of image analysis based CDx.
“Flagship is committed to providing our customers a continuous path for their tissue image analysis solutions as a Companion Diagnostics (CDx) into the clinical market.” said Dr. David Young, CEO and President of Flagship Biosciences. “Now we can take our tissue image analysis solutions and develop and manufacture them as medical device software as part of a Companion Diagnostics approach.”
“How the final medical device for a Companion Diagnostics will look depends on our customers’ needs and their business relationships,” said Dr. Holger Lange, Chief Technology Officer of Flagship Biosciences. “Flagship is flexible, and can provide our customers different options which suit their needs. We can develop our image analysis applications as medical device software to be integrated into third party digital pathology platforms, or we can provide a complete slide analysis system through commercialization of TALIS™ for the clinical market, which can work with a variety of slide scanners to run our image analysis applications for CDx.”
“From a Companion Diagnostic clinical trials perspective, there is little to no risk that the transition of our image analysis quantification approach changes the performance of the image analysis application. The image analysis solutions are developed as a Laboratory Developed Test (LDT) to support patient enrichment and/or selection strategies to a manufactured medical device software with IVD labeling.” said Dr. Joseph Krueger, Chief Scientific Officer of Flagship Biosciences. “With the Quality Management System (QMS) now in place, the image analysis portion of CDx with clinical utility in the exploratory setting can be transitioned seamlessly into a commercial CDx under the appropriate regulatory pathway.”