The FDA published guidance on what types of Clinical Decision Support(CDS) software are considered medical devices or exempted from regulation. The FDA will supervise the software for processing NGS data and identifying variations based on NGS data. Industry officials involved in the software need to be prepared for the regulation.
The UK's National Health Service England(NHS) has announced a five-year plan to expand the application of genomic analysis to the UK's health care system. The NHS wrote that it will convert newborn screening tests from the existing whole exome sequencing(WES)-based test to whole genome sequencing(WGS)-based test within 2022.
영국의 NHS(National Health Service England)가 영국의 보건의료 시스템에 유전체 분석을 확대 적용하는 5개년 계획을 발표했습니다. NHS는 2022년 이내에 신생아 선별검사를 기존 WES 검사에서 WGS 검사로 전환하겠다고 밝혔습니다. Original Article: NHS England.Accelerating genomic medicine in the NHS
The Association for Molecular Pathology(AMP) has issued guidelines on using in silico data to validate NGS data analysis pipelines. The recommendations were also published in the College of American Pathologists(CAP). It contains information on benefits and cautions when using in silico data.