The panel also said that if any nation does decide to allow germline genome editing, its use should be limited to preventing serious monogenic diseases.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
The guidance suggests validating a five-sample pooling strategy, but notes that this may need to be adjusted depending on assay sensitivity and local prevalence.
Russia says its candidate SARS-CoV-2 vaccine has a very high efficacy rate in an initial analysis of clinical trial data, according to the Financial Times.
