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Johnson & Johnson Genetic Testing | FDA Approved July 18, 2007

Posted by ramunas in breast cancer, cancer genetics, GeneSearch, genetic testing, sporadic cancer.
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Did you know that “baby friendly” company Johnson&Johnson has in vitro diagnostics oncology products company called Veridex? Yesterday U.S. Food and Drug Administration (FDA) approved the first intra-operative and gene-based test to detect the spread of breast cancer into the lymph nodes. Its GeneSearch™ Breast Lymph Node (BLN) assay (for in vitro use only) can detect the spread of cancer into the lymph nodes more accurately than existing rapid methodologies and, as a result, has the potential to reduce the need for stressful and costly second surgeries for breast cancer patients.

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 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. [via]

It claims to detect metastases greater than 0.2mm in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients and gives rapid, reproducible, objective results, which can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes.

It’s based on reverse transciptase polymerase chain reaction (RT-PCR) assay that detects metastatic tumor expression markers: Mammaglobin (MGB1) and Cytokeratin 19 (KRT19) , which are present in higher level in breast cancer, but not in nodal tissue (i.e. tissue specific RNA expression).

In clinical trials with more than 300 patients in the U.S. that compared performance of GeneSearch(TM) with commonly performed intra-operative test procedures, GeneSearch(TM) correctly identified 95.6 percent of patients who had metastases in their lymph nodes. This high accuracy in finding metastases was statistically superior to the most commonly performed intra-operative test procedure. The new, gene-based technology of the GeneSearch(TM) test allows for the analysis of 50 percent of the sentinel node, versus five percent of tissue typically examined under a microscope for evidence of cancer cells. Test results from GeneSearch(TM) can be produced in 35 to 40 minutes during the initial surgical procedure versus two to three days with tissue pathology. (via)

The test is intended for use of customers, patients and healthcare professionals in the United States. It is also CE marked and is commercially available in the EU.

Breast cnacer is the most common cancer and the second leading cause of cancer death in western world. The average lifetime riks for a woman in the western world (or populational risk) varries from 1 in 8-10.
More than 40,000 women in the U.S. die from breast cancer annually and given level of accuracy, GeneSearch(TM) has the potential to prevent the need for costly and traumatic second surgeries for as many as 5,200 additional breast cancer patients in the U.S. each year. [via]

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Comments»

1. Victor Levenson - July 18, 2007

This is an interesting development, but what is the accuracy of the test? Sensitivity (% of true positives detected) and specificity (% of true negatives detected)? Without these features – I am sure they have been determined, but could not find them on the Veridex page or in the message – it is very difficult to assess the test. As a comparison, the blood-based DCIS detection test developed in my lab has 84% sensitivity and 80% specificity, and we are reluctant to move it to the clinic at this point. Once it is 97%-99%, then this will make sense.

2. ramunas - July 19, 2007

yes, sensitivity and specificity are crucial. think it should be provided in veridex physician brochure: http://www.veridex.com/pdf/VX10048-BLN_Information_for_Physicians.pdf

3. Gene-expression Profiling in Cancer | A Brief Review « www.cancer-genetics.com - July 24, 2007

[…] Veridex research, a two genes expression The GeneSearch™ Breast Lymph Node (BLN) Assay test was recently approved dy FDA, and is based on RT-PCR (i.e. for analysis in […]

4. Nomogram vs GeneSearch | Breast Cancer « www.cancer-genetics.com - August 23, 2007

[…] FDA approved Johnson&Johnsons GeneSearch™ Breast Lymph Node (BLN) assays results, which claims to detect the spread of breast cancer into the lymph nodes by analyzing the level of metastatic tumor […]

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