Webinar: Next Generation Sequencing Draft Guidances for Patients and Providers скачать в хорошем качестве

Webinar: Next Generation Sequencing Draft Guidances for Patients and Providers

FDA has released 2 regualtory guidances regarding the use of these NGS-based tests, which can be used to inform risk and treatment decisions across multiple tumor types: 1. The first guidance on the Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” provides recommendations for designing, developing, and validating NGS-based tests for rare hereditary diseases, and addresses the potential for using FDA-recognized standards to demonstrate how well a test predicts the presence or absence of a particular genomic change. 2. The second draft guidance, Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics; describes an approach wherein test developers may rely on clinical evidence from FDA-recognized public genome databases to support clinical claims for their tests and provide assurance of accurate clinical interpretation of genomic test results allowing for an easier path for marketing clearance or approval. This webinar discusses the two guidances and answers frequently asked questions about using NGS.