This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: GeneSearch™ BLN Test kit
PMA Applicant: Veridex LLC
Address: 33 Technology Drive, PO Box 4920,Warren, NJ 07059
Approval Date: July 16, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060017a.pdf
What is it? The GeneSearch BLN Test Kit is a qualitative in vitro diagnostic test for the rapid detection of metastases larger than 0.2 mm in nodal tissue removed from http://www.cancer.gov/Templates/db_alpha.aspx?CdrID=45733 biopsies of breast cancer patients. (See explanation of sentinel lymph node, below.)
How does it work? The GeneSearch™ BLN Test detects the spread of breast cancer to lymph nodes by chemically replicating (amplifying) two gene products (messenger RNAs, or mRNAs) that are abundant in breast tissue and scarce in lymph node cells. If groups of growing breast cancer cells (metastases) are in the lymph nodes, a strong fluorescent signal is produced for one or both of the gene products. Absence of such a signal means that metastases are not present. A third fluorescent signal, for a gene product that is abundant in normal lymph node tissue, indicates that a negative test result is correct.
When is it used? During surgery to remove breast tumors, patients often undergo biopsy of the sentinel (i.e., first) node(s) that receive lymphatic fluid from the breast. The GeneSearch™ BLN Test is a new way to examine the extracted sentinel lymph nodes for metastases. If metastases are found, additional lymph nodes might need to be removed. Follow-up examination of remaining sentinel lymph node tissue under a microscope is required.
What will it accomplish? Results from the GeneSearch™ BLN Test can be used by the doctor during surgery or after surgery, in deciding whether to remove additional lymph nodes.
When should it not be used? The GeneSearch™ BLN Test is not approved for use on lymph nodes other than sentinel lymph nodes from breast cancer patients. Lymph nodes that are too small to examine with both the GeneSearch™ BLN Test and under a microscope should be examined by microscopy alone. The GeneSearch™ BLN Test should not be used in patients previously diagnosed with lymphoma, because false positive results may be increased.
Additional information: The GeneSearch™ Breast Lymph Node (BLN) test may be used with sentinel lymph node biopsy for patients who have been informed about the risks, benefits and limitations of this test. True positive results may prompt the removal of additional lymph nodes during initial surgery. False positive results may lead to unneeded surgery and its associated risks. False negative or inconclusive test results may delay the needed removal of additional lymph nodes. Though treatment for metastases larger than 2.0mm is widely accepted as beneficial, clinical studies have not yet provided data for a consensus on benefit from treatment based on very small breast cancer metastases (between 0.2mm and 2.0mm) in sentinel lymph nodes.
Please see the instructions for use, the physicians’ brochure, and the patients' brochure, all of which are available on the Veridex Web Site or by contacting Veridex Customer Technical Services.
Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060017.