Affymetrix signed two agreements with Sysmex to distribute, develop, and market in vitro diagnostic tests. A clinical development and marketing agreement grants Sysmex exclusive rights to distribute Affymetrix' diagnostic microarray products and instrumentation in Japan with the opportunity to expand into certain Asia-Pacific countries.
In addition, a Powered by Affymetrix™ agreement gives Sysmex nonexclusive access to Affymetrix microarray technology to develop and market in vitro diagnostic tests on a worldwide basis.
Sysmex will carry out all registration, sales, and customer support activities for the diagnostic instrumentation, array, and reagent products as the Affymetrix distributor for Japan.
The Powered by Affymetrix agreement enables Sysmex to incorporate Affymetrix' patented arrays into its diagnostic products. It is expected that the resulting microarray-based tests will enable clinicians to provide more efficient and complete methods to diagnose, classify, and manage these disorders.
Affymetrix’ GeneChip® System 3000Dx (GCS3000Dx), a microarray for molecular diagnostic laboratories, has been cleared by the FDA as well as CE marked for in vitro diagnostic use. Affymetrix and its Powered by Affymetrix partners are developing array-based tests for use with this system.