2 Medical Tests Clear FDA Panels: Food...

2 Medical Tests Clear FDA Panels: Food and Drug Administration advisory committees have recommended approval of a new test for tuberculosis and of a new way of testing the effectiveness of a cancer drug.

The FDA said the TB test recommendation was conditioned on more data being supplied to the federal agency by Genprobe Inc., the San Diego manufacturer of the test. The TB test amplifies genetic material in specimens and then uses a radioactive tracer to detect the presence and activity of the TB bacteria.

In the cancer test, an advisory board recommended approval of a process developed by Bartels Prognostics Inc. of Kirkland, Wash., that determines if cancer cells are sensitive to the cancer drug 5-Fluorouracil. The FDA said the laboratory test uses a concentration of tumor cells and a radioactive tracer to determine if a specific cancer is sensitive to the drug. Tumor cells that are sensitive to the drug give low radioactive readings, but the cells that resist the drug give strong readings.

The FDA generally follows the recommendations of its advisory panels, but the agency is not required to do so.