Gold Standard Diagnostics Signs U.S. Distribution Agreement With Fujirebio Diagnostics for Multi-Constituent Tumor Marker Control

Agreement provides exclusive rights to distribute the Multi-Constituent Tumor Marker Control

DAVIS, Calif.--(BUSINESS WIRE)--Gold Standard Diagnostics, Corp., (GSD) http://www.gsdx.us/ a leading supplier of products and services to the medical diagnostic industry, today announced the execution of an agreement with Fujirebio Diagnostics to distribute their proprietary Multi-Constituent Tumor Marker Control in the United States. Fujirebio Diagnostics, best known in the U.S. market as the developers of the CA125 ovarian cancer marker, has several patents on biomarkers for various disease states, but is primarily focused on oncology markers.

Multi-Constituent Control

The Fujirebio Diagnostics Tumor Marker Control allows laboratories to monitor the precision and accuracy of assays used in the monitoring of progression and response to treatment for various cancers. The Tumor Marker Control includes AFP, CEA, Total-PSA, Free-PSA, CA125, CA19-9, CA15-3, CA27.29, CA242, Ferritin and is the only multi-constituent control to contain the proprietary marker HE4. In order to provide a control that closely resembles a patient sample, the control has been developed with a 100% human serum matrix, improved stability and clinically relevant proportions of Free-PSA and PSA-ACT (to assess performance of a Total PSA assay). In addition, the target values have been established at medically relevant analyte levels to ensure precision and accuracy around medical decision points.

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. Fujirebio Diagnostics is one of the group companies of Miraca Holdings, Inc., in Japan, set up in July 2005 to combine Fujirebio Inc., the leading in-vitro diagnostics company, and SRL, Inc., the top provider of clinical laboratory testing services in Japan. Fujirebio Diagnostics has a worldwide distribution network which enables physicians and patients to access its diagnostic products.

About Gold Standard Diagnostics

Gold Standard Diagnostics is Davis, California based sales, marketing, and distribution company, who partners with reagent and equipment manufacturers from around the world, creating innovative and cost effective diagnostics solutions for clinical and hospital laboratories. GSD also develops its own suite of proprietary products, including the recently launched Thunderbolt ™ platform, which provide laboratories the next wave of technology-based solutions. For more information please call 530-759-8000 or visit www.gsdx.us.