LAWMAKERS INTRODUCE BILL TO STRENGTHEN OVERSIGHT OF LABORATORY-DEVELOPED TESTS

Sens. Edward Kennedy (D-Mass.) and Gordon Smith (R-Ore.) introduced the "Laboratory Test Improvement Act," which will mandate that all providers of laboratory-developed, or "homebrew," tests provide the FDA with evidence of the tests' analytical and clinical validity.

All information about the tests submitted to the FDA will be compiled into a database that will be made available to the public on the internet, the lawmakers said.

The bill would also allow for the enhanced reimbursement of cleared and approved tests.