Dako said this week that it has gained CE-marking for the use of its HercepTest and HER2 FISH pharmDx tests in metastatic stomach cancer patients who may benefit from Herceptin treatment.
The CE-marking is based on the results of a study of more than 3,700 patients that showed that treatment with Herceptin significantly prolonged the lives of patients with metastatic HER2-positive stomach cancer detected via Dako's tests.
Overall survival for patients with high levels of HER2 in the study was 16 months for patients treated with chemotherapy and Herceptin versus 11.8 months for patients receiving chemotherapy alone.
Approximately one in five of all stomach tumors are HER2-positive, Dako said.
HercepTest is an immunohistochemistry assay used to identify patients with HER2-positive cancer while HER2 FISH pharmDx is a direct fluorescence in situ hybridization assay to quantitatively determine HER2 gene amplification.
Pathway Genomics has released its personal Genetic Health Report, a customized report for its direct-to-consumer genomic service that contains information on more than 70 health conditions, including pharmacogenetics, propensity for complex disease, and carrier status.
The company performs the genetic analysis for its DTC service in an onsite laboratory that is CLIA-certified and licensed in the state of California.
Pathway said that its report provides pharmacogenetic information for Plavix, warfarin, abacavir, carbamazepine, methotrexate, statins, and tamoxifen.