Interpreta Spotlights Regulatory Landscape for Clinical Sequencing

September 18, 2015 - In an invited meeting review, Interpreta Vice President of Clinical Informatics and Genomics, Dr. Benjamin Yu, reports on the industry landscape and positions of governmental, academic, professional, patient advocacy and manufacturing groups on clinical regulation of next generation sequencing (NGS). The meeting which took place in February was sponsored by the FDA was public discussion among stakeholders on the regulatory standards and requirements for clinical sequencing. This critical discussion will continue in two newly announced NGS workshops in November on clinical standards and genomic interpretation.

Dr. Yu contends that this regulatory landscape will define clinical applications and the healthcare marketplace for decades to come.  He says that billions of dollars are at stake for the manufacturers, labs, and healthcare. Dr. Yu claims that increased accessibility to NGS testing and improved understanding of the genetic basis for disease have brought “precision medicine” closer to reality but translation of the benefits of NGS testing into clinical practice remains a major bottleneck. He states that if healthcare delivery of actionable sequencing data can be solved, patients will benefit from an unprecedented precision in care, and the marketplace will expand to new heights. 

Read more in the Journal of Investigative Genomics MedCrave.