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The Success of Gene Therapy Depends on Diagnostic Testing

In this Knect365 article, David Parker, PhD, Precision’s Senior VP, Diagnostics Solutions, explains why diagnostic tests are of critical importance to both the commercial and therapeutic success of gene therapies.

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Precision’s team of experts have deep scientific understanding and significant experience in all aspects of bringing diagnostics, companion diagnostics, and their associated therapeutics to market – including assay development, clinical trial design and execution, regulatory strategy, registration, and commercialization.

Regulatory strategy development and execution. Our regulatory experts offer comprehensive to-market regulatory and evidence development strategies that anticipate areas of regulatory risk. We handle every facet of regulatory approval, from ISO and CLIA certification to authoring FDA, EU and rest-of-world submissions.

Market access, clinical utility, and evidence strategies. Our team both understands and can effectively present the information that payers require – including codes, fee schedules, coverage processes, and evidence – helping to provide rapid market access.

Pre-submission and marketing clearances. Precision has delivered over 250 proven market clearances and over 100 IVD pre-submissions globally, along with numerous favorable coverage and payment decisions for both diagnostics and companion diagnostics – among which are several game-changing, first-to-market innovations.

Diagnostic development reinvented: Comprehensive services from early development through product launch

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.