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.
The bill, which was introduced in the House and Senate, would resolve longstanding questions around the FDA's authority to regulate laboratory-developed tests.
Industry organizations like ACLA are seeking changes to the bill, which appears to outlaw standard business practices such as paying sales staff on commission.
The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.
A tick-borne disease working group recommends the federal government explore using new technologies and repurposing existing ones to improve diagnosis.
