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Dear Reader, We wish you all the best for 2005 - May we all live in health, peace and prosperity. Affymetrix Inc. received FDA clearance to market the Affymetrix GeneChip System 3000Dx (GCS 3000Dx), an instrumentation system to analyze IVD microarrays. This is the first microarray instrument to be cleared by the FDA for IVD use. The FDA clearance of the Affymetrix GCS 3000Dx follows the August ISO certification of the instrument and array manufacturing facilities and the September IVD CE marking of the instrument system in the European Union. Affymetrix collaborates with its Powered by Affymetrix partners to develop genotyping and gene expression diagnostics on the GCS 3000Dx system. Affymetrix Inc. granted Veridex, LLC, a Johnson & Johnson company, long-term and comprehensive access to its GeneChip technology to create and market in-vitro diagnostics for cancer. The agreement, made under the Powered by Affymetrix program, gives Veridex non-exclusive rights to Affymetrix' patented arrays, instrumentation systems and planned improvements to these key technologies. Genomic Health Inc. developed the Oncotype DX Recurrence Score Assay used to predict which breast cancer patients are at risk for distant recurrence and which patients will benefit from tamoxifen or chemotherapy. Recurrence score measures the expression of 21 genes (16 directly related to cancer development and five included as reference genes), and converts the measurements into a score ranging from one to 100. Based on the recurrence score, patients can be rated as low risk (score less than 18), intermediate risk (score between 18 and 30), or high risk (score greater than 30) for distant recurrence. Stratagene Corporation launched the Mx3005P Real-Time PCR System, the latest in the company's line of QPCR instrumentation. The system is an open platform design that supports all fluorescent dyes and chemistries including Stratagene's proprietary FullVelocity reagents. The U.S. list price for the Mx3005P is $29,900.
Molecular Biology - November 2004
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