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AACC noted that the number of sites performing clinical lab testing in the US has risen to 266,000 in 2020 from 154,000 in 1993.

Saying pooled testing for coronavirus was not for diagnostic purposes, Cigna had said it wouldn't reimburse for the method, but it plans to change its policy.

The funding package earmarks billions for the Public Health and Social Services Emergency Fund and Biomedical Advanced Research and Development Authority.

The letter calls for expanded access to COVID-testing for everyone regardless of insurance coverage or reason for receiving the test.

The lawmakers requested the secretary to direct money from the Public Health and Social Services Emergency Fund to support clinical labs.

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 VITAL Act strikes a counterpoint to another bipartisan-backed bill, called VALID, that would give FDA oversight responsibilities over all clinical tests, including LDTs.

A pathologists' group has pointed out that the bill covers only EUA tests, and patients receiving tests with pending regulatory status may receive surprise bills.

The bill, which was introduced in the House and Senate, would resolve longstanding questions around the FDA's authority to regulate laboratory-developed tests.

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