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Diagnostics Policy & Legislation

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

The COVID-19 pandemic is the highest priority for most, but laboratory organizations are also looking ahead with longer-term goals for the new presidency.

The assay can be used to pool up to five specimens collected from individuals suspected of having COVID-19 or from asymptomatic patients.

The government will provide around 670,000 rapid antigen tests to local health officials across England this week to expand testing in asymptomatic individuals.

Among its recommendations, the FDA said antigen tests for the coronavirus should have a minimum sensitivity of 80 percent for all sample types submitted.

While the guidance was welcome after years of uncertainty, regulatory experts say it does not provide enough detail for IVD manufacturers.