First Molecular-Based Lab Test to Detect Metastatic Breast Cancer, Approved by the FDA

Filed in archive Diagnostics, Methodologies and Instrumentation on July 18, 2007

Now breast cancer patients may be able to forgo an invasive procedure to determine if their cancer has metastasized or spread in other parts of the body.

A Johnson & Johnson company - Veridex - has developed and manufactured a molecular-based lab test that will determine metastatic breast cancer: the GeneSearchâ„¢ Breast Lymph Node (BLN) Assay.

The good news is that, the FDA has just approved this test.

According to Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health:

"The GeneSearch BLN Assay offers a new approach to sentinel node testing. Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation."

Find more details from the full report.