Lani
12-20-2006, 01:46 PM
Soon to be FDA approved:
Molecular Assay of Lymph Nodes in Real-Time Has High Sensitivity
CME
Non-Small-Cell-Lung Cancer (NSCLC)Integrating Targeted Treatments Into Standard Regimens for Patients With Advanced NSCLC
Click here to learn more.
By Martha Kerr
NEW YORK (Reuters Health) Dec 19 - A new multiplex molecular assay offers real-time results of lymph node analysis during breast cancer surgery. The GeneSearch BLN Assay (Veridex, LLC, Warren, New Jersey) has a high specificity and greater sensitivity than standard histology of lymph nodes, investigators announced this week at the 29th annual meeting of the San Antonio Breast Cancer Symposium.
"The gold standard is histology and evaluation of the lymph nodes, which takes several days, and only evaluates about 85% of a node," principal investigator Dr. Peter W. Blumencranz of Morton Plant Mease Hospital in Clearwater, Florida, told Reuters Health before his presentation.
The GeneSearch BLN Assay uses mammaglobin and cytokeratin 19 markers to detect metastases.
In a comparison of the molecular assay with intra-operative nodal analysis using frozen sections in 319 women treated at 11 clinical sites, Dr. Blumencranz's team found an overall sensitivity of 95.6% with the molecular assay compared with 85.6% with frozen sections. On nodal sections greater than 0.2 mm, frozen sections had a sensitivity of 54.5% and the molecular assay had a sensitivity of 81.8%. The specificity was 97.8% with frozen sections compared with 94.3% with the GeneSearch BLN Assay.
"This is the future, we believe," Dr. Blumencranz said. "We don't use a microscope. Instead, we look at the lymph node on a molecular, subcellular level. The molecular assay is instead of a cellular analysis, and the results take only 35-50 minutes, well within the intra-operative period," he explained.
"The big issue during surgery is which nodes to sample. Here, we're not assaying more nodes but more of a node. We're looking at fully half of that node. We're looking at markers that would not be present if cancer is present."
"We can't make (the assay) too sensitive, otherwise it would have no clinical significance," Dr. Blumencranz said. "We aren't completely eliminating sampling error, and there is some operator variability," but to a much lower degree than with standard histology.
"In November, we went in front of an FDA Advisory Committee, and they voted in favor of approval," Dr. Blumencranz said. "We expect it to go to full FDA approval in early '07."
Molecular Assay of Lymph Nodes in Real-Time Has High Sensitivity
CME
Non-Small-Cell-Lung Cancer (NSCLC)Integrating Targeted Treatments Into Standard Regimens for Patients With Advanced NSCLC
Click here to learn more.
By Martha Kerr
NEW YORK (Reuters Health) Dec 19 - A new multiplex molecular assay offers real-time results of lymph node analysis during breast cancer surgery. The GeneSearch BLN Assay (Veridex, LLC, Warren, New Jersey) has a high specificity and greater sensitivity than standard histology of lymph nodes, investigators announced this week at the 29th annual meeting of the San Antonio Breast Cancer Symposium.
"The gold standard is histology and evaluation of the lymph nodes, which takes several days, and only evaluates about 85% of a node," principal investigator Dr. Peter W. Blumencranz of Morton Plant Mease Hospital in Clearwater, Florida, told Reuters Health before his presentation.
The GeneSearch BLN Assay uses mammaglobin and cytokeratin 19 markers to detect metastases.
In a comparison of the molecular assay with intra-operative nodal analysis using frozen sections in 319 women treated at 11 clinical sites, Dr. Blumencranz's team found an overall sensitivity of 95.6% with the molecular assay compared with 85.6% with frozen sections. On nodal sections greater than 0.2 mm, frozen sections had a sensitivity of 54.5% and the molecular assay had a sensitivity of 81.8%. The specificity was 97.8% with frozen sections compared with 94.3% with the GeneSearch BLN Assay.
"This is the future, we believe," Dr. Blumencranz said. "We don't use a microscope. Instead, we look at the lymph node on a molecular, subcellular level. The molecular assay is instead of a cellular analysis, and the results take only 35-50 minutes, well within the intra-operative period," he explained.
"The big issue during surgery is which nodes to sample. Here, we're not assaying more nodes but more of a node. We're looking at fully half of that node. We're looking at markers that would not be present if cancer is present."
"We can't make (the assay) too sensitive, otherwise it would have no clinical significance," Dr. Blumencranz said. "We aren't completely eliminating sampling error, and there is some operator variability," but to a much lower degree than with standard histology.
"In November, we went in front of an FDA Advisory Committee, and they voted in favor of approval," Dr. Blumencranz said. "We expect it to go to full FDA approval in early '07."