Veridex, LLC, a Johnson & Johnson company in vitro diagnostics oncology

The GeneSearch™ Breast Lymph Node Assay - the first FDA-approved molecular diagnostics assay for breast lymph node testing represents a potentially new standard of care in intra-operative breast lymph node testing, offering the chance for:

fewer second surgeries and hospital stays
improved overall quality of patient care
rapid, reproducible, objective results
detection of metastases greater than 0.2 mm
analyze up to 50% of the lymph node

For a complete list of materials required to run the GeneSearch™ BLN Assay please refer to the Instructions for Use (IFU)

The GeneSearch™ Breast Lymph Node (BLN) Assay may be used in conjunction with sentinel lymph node biopsy for a patient who has been counseled on use of this test and has been informed of its performance. False positive results may be associated with increased morbidity. False negative and inconclusive test results may be associated with delayed axillary node dissection. Clinical studies so far are inconclusive about a benefit from treatment based on findings of breast cancer micrometastases in sentinel lymph nodes.

Intended Use

For in vitro diagnostic use only.

The GeneSearch™ Breast Lymph Node (BLN) Assay is a qualitative, in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes.

Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Veridex lymph node cutting scheme, is required.

For complete information on Intended Use, Warnings and Precautions, and Limitations, see the Instructions for Use (IFU).

This information is intended for use by our customers, patients and healthcare professionals in the United States only. Veridex recognizes that the internet is a global communications medium; however, laws, regulatory requirements and medical practices for in vitro diagnostic devices vary from country to country. The information included here may not be appropriate for use outside the United States. Product availability is subject to local regulatory authority approvals.

GeneSearch™ is a trademark of Veridex, LLC.