MONDAY, July 16, 2007 (HealthDay News) -- The first molecular laboratory test to help doctors detect whether breast cancer has spread to nearby lymph nodes has been approved by the U.S. Food and Drug Administration, the agency said Monday.
The GeneSearch BLN Assay detects molecules that are abundant in breast tissue but are normally rare in lymph nodes. The body's lymphatic system helps protect against infection.
The first lymph node that filters fluid from the breast is called the "sentinel node," which is commonly removed during a lumpectomy or mastectomy because it's where breast cancer cells are most likely to spread first, the agency said. The GeneSearch test offers an additional way to evaluate the sentinel node.
In clinical testing involving 416 women, the test accurately predicted that breast cancer had spread 88 percent of the time. Among women in whom cancer hadn't spread, the test was 94 percent accurate, the FDA said.
The test is manufactured by a New Jersey-based Johnson & Johnson subsidiary, Veridex, LLC.
To learn more about metastatic breast cancer, visit the U.S. National Cancer Institute.