Molecular Test Detects Breast Cancer Lymph Node Micrometastases

A rapid molecular test is used during surgery to detect breast cancer micrometastases in the sentinel lymph node.

During surgery for breast cancer doctors typically remove the lymph node nearest to the tumor and test it after surgery to determine if the cancer has spread. The molecular test, marketed by Veridex LLC (North Raritan, NJ, USA), takes about 35 minutes to produce results and can be done while the primary tumor is being removed.

In a study, reported by Denis Larsimont, M.D., Ph.D., of the Jules Bordet Institute (Brussels, Belgium; www.bordet.be), and colleagues at the first IMPAKT [IMProving cAre and Knowledge through Translational Research] Breast Cancer Conference, held on May 7-9, 2009 in Brussels (Belgium), the molecular test was used during breast cancer surgery on 1,138 women in four U.S. sites and one each in Belgium and the United Kingdom. Results of the molecular test were compared with what was seen using traditional permanent section histology. Analysis of the results showed that traditional histology had a negative predictive value of 90%, compared with 96% for the new test. When the two methods were combined, the negative predictive value was 99%.

"The assay dramatically reduces the need for second surgery," said Dr. Larsimont, and the high negative predictive value should "assure the pathologist, surgeon, and patient that occult metastases are unlikely." He added that the key finding of the study was that if the test is negative, it is highly unlikely that the cancer has spread to the other nodes."

The IMPAKT conference was designed to present and discuss advances in translational research and ways to quickly transform laboratory discoveries into tools that clinicians can use to help make decisions about the way they treat patients in their daily practice.

Veridex, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring, and therapeutic selection. The company is initially developing two complementary product lines: CellSearch assays that identify, enumerate, and characterize circulating tumor cells directly from whole blood and GeneSearch assays.

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Jules Bordet Institute