A Diagnostics & Imaging Week

Affymetrix (Santa Clara, California) and Asuragen (Austin, Texas), a molecular biology diagnostic company and service provider, have agreed to develop in vitro transcription (IVT) reagent kits for clinical molecular diagnostic applications.

Affymetrix said that the new IVT reagent kits manufactured by Asuragen will enable it to deliver a complete solution to its molecular diagnostic partners. The products will be designed for clinical use and will be configured for use with the GeneChip System 3000Dx. Affymetrix said that the chip is the only available diagnostic microarray platform that has earned both 510(k) clearance and CE marking.

Kevin King, president of Affymetrix, said, "The Asuragen IVT reagent kit will strengthen our growing diagnostic product portfolio."

"Affymetrix offers a continuous path to discover, develop and commercialize biomarker signature assays," said Matt Winkler, chief scientific officer and CEO of Asuragen. "These new reagent kits will facilitate more adoption of Affymetrix microarray technology by significantly improving workflow in the clinical diagnostic laboratory."

Affymetrix says it is partnering with the leading diagnostic companies through the Powered by Affymetrix (PbA) Program to bring to market new diagnostic tests that employ the latest genomic discoveries. There are currently more than 20 different molecular assay tests based on the Affymetrix platform under development by Affymetrix and its 11 PbA partners, the company noted. The resulting microarray-based tests will enable clinicians to provide more efficient and complete methods to diagnose, classify and manage patients suffering from complex diseases like cancer.

Asuragen's current diagnostic product portfolio consists of Signature Genetic Testing and Oncology Testing products as well as controls and standards engineered with its Armored RNA technology.

Affymetrix GeneChip microarray technology is the industry-standard tool for analyzing complex genetic information, according to the company. Pharmaceutical, diagnostic and biotechnology companies, as well as academic, government and not-for-profit research institutes, use its technology.