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12-14-2011, 11:39 AM
FDA Clears Dako's Companion Dx for Herceptin
December 13, 2011
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By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – The US Food and Drug Administration late last month approved a Dako test for use as a companion diagnostic for determining which patients may benefit from treatment with Herceptin (trastuzumab).
The Danish cancer diagnostic firm's HER2 CISH pharmDx Kit measures copies of the HER2 gene in formalin-fixed, paraffin-embedded breast cancer tissue specimens by using a chromogenic in situ method, and results "are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients," FDA said in its approval letter to Dako.
The CISH procedure is automated on Dako's Autostainer instruments.
During the summer, FDA cleared a test made by Ventana Medical Systems, part of the Roche Group, which measures the number copies of the HER2 gene for use as a tool to determine patients who may be candidates for Herceptin, manufactured by Genentech, also a Roche company.
Dako's HercepTest and Her2 FISH pharmDx were approved by FDA last year to guide treatment of patients with Herceptin in combination with chemotherapy for HER2-positive metastatic cancer of the stomach or gastroesophageal junction in men and women who have not received prior medicines for their metastatic disease.
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December 13, 2011
Type size: -+
Printer-friendly version
RSS Feed
By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – The US Food and Drug Administration late last month approved a Dako test for use as a companion diagnostic for determining which patients may benefit from treatment with Herceptin (trastuzumab).
The Danish cancer diagnostic firm's HER2 CISH pharmDx Kit measures copies of the HER2 gene in formalin-fixed, paraffin-embedded breast cancer tissue specimens by using a chromogenic in situ method, and results "are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients," FDA said in its approval letter to Dako.
The CISH procedure is automated on Dako's Autostainer instruments.
During the summer, FDA cleared a test made by Ventana Medical Systems, part of the Roche Group, which measures the number copies of the HER2 gene for use as a tool to determine patients who may be candidates for Herceptin, manufactured by Genentech, also a Roche company.
Dako's HercepTest and Her2 FISH pharmDx were approved by FDA last year to guide treatment of patients with Herceptin in combination with chemotherapy for HER2-positive metastatic cancer of the stomach or gastroesophageal junction in men and women who have not received prior medicines for their metastatic disease.
Related Stories
Dako, Genentech Partner on Companion Dx FDA Submission for Pertuzumab
December 9, 2011 / GenomeWeb Daily News
FDA Approves HER2 Test for Breast Cancer
June 14, 2011 / GenomeWeb Daily News
Dako Gets FDA OK for HER2 Tests for Gastric, Stomach Cancer
October 21, 2010 / GenomeWeb Daily News
FDA Clears Abbott's AML Prognosis Assay
October 24, 2011 / GenomeWeb Daily News
Qiagen Submits Second PMA for Therascreen KRAS Companion Dx
August 5, 2011 / GenomeWeb Daily News