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.
FDA officials said at ACLA's annual meeting that the agency's efforts to balance rapid test access with safety during the coronavirus crisis carries lessons for the oversight of all tests.
The bipartisan bill is backed by more than 250 organizations, but ACMG remains opposed, arguing that ordering tests is part of the practice of medicine.
The legislation is intended to allow states to conduct whole-genome sequencing on children on Medicaid who have a disease with a suspected genetic cause.
The bipartisan bill aims to provide federal support to children who are ill from an unknown cause and could gain insights into diagnosis or treatment approaches via WGS.
