HTG Molecular offers solutions to several of the many challenges to successfully completing a clinical trial. Often, clinical trial leaders encounter difficulty reconciling a signature that transcends in vitro, in vivo and clinical models; retention of a signature in the transition from fresh tissues to FFPE; or finding a clinically deployable solution that allows for true multiplexing. Clinical trial leaders have reported difficulty in finding and partnering with service providers with the expertise and sophistication in clinical trial management and commercial deployment.

HTG Molecular confidently and dependably provides timely, cost effective solutions for these and other potential roadblocks on the path of companion diagnostic approval. Our clinical trial support advisors offer the benefit in-depth and practical experience in assay development and clinical deployment. HTG Molecular solutions can assist with prototype development, companion proof of concept, and design control IVD assay development. HTG Molecular teams can monitor clinical trial labs to ensure efficient and accurate test results; gather data for intra- and inter-lab reproducibility and prepare and submit Class III PMA applications with intended use linked to drug therapy selection and commercialization.