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Diagnostics Policy & Legislation

News on government policy and legislation impacting life science and diagnostics.

Issued last week, the guidance said insurers were not required to reimburse such testing, which could impact coverage in schools, workplaces, and other settings.

The experts said that antibody testing cannot indicate an individual's immunity or help with return-to-work schemes but have use for public health agencies.

The recommendations are intended to improve testing capacity for SARS-CoV-2 by providing ways to combat testing supply shortages and expanding funding, among other steps.

The bills would award grants to help public health laboratories purchase high-throughput instruments and to help support diagnostic testing outside of the lab setting.

The agency will now require commercial antibody test manufacturers to meet certain sensitivity and specificity thresholds.