Abbott and BioGenex Enter Agreement for Automated Molecular Diagnostics System

Abbott Laboratories and BioGenex Laboratories today announced an agreement to distribute and market a new system that will fully automate molecular diagnostic tests that employ Abbott’s proprietary Fluorescence in situ Hybridization (FISH) technology.

The system is designed to automate all of the assay steps required to perform Abbott’s FISH-based tests, including the application, removal and re-application of the coverslip resulting in a completely finished slide that is ready to go directly on the microscope for review. It is expected to be introduced to the market in the near future, pending regulatory clearance.
“The increasing demand for molecular testing is putting pressure on clinical laboratories to process these tests more quickly,” said Edward L. Michael, president, Abbott Molecular Diagnostics, Abbott Laboratories. “By further automating our FISH technology, we can help our customers keep up with the workflow demands, save labor costs, further enhance test reliability and, ultimately, improve patient care.”

“We are pleased that Abbott has elected to distribute our products integrated with their FISH applications worldwide,” said Krishan Kalra, Ph.D., chairman and CEO, BioGenex. “This underscores application of BioGenex technology for harnessing the power of genomics to accelerate the pace of molecular medicine. Our partnership offers an excellent opportunity to co-develop and commercialize workflow solutions for a multitude of diagnostic applications.”

Under the terms of the agreement, Abbott has co-exclusive rights with BioGenex to market and distribute the new system worldwide in the FISH field. Abbott and BioGenex will collaborate to further develop automated solutions for FISH applications. As part of the agreement, BioGenex has received a multi-year minimum volume commitment and an upfront payment toward future purchases of systems.

About FISH
FISH technology provides the ability to see multiple chromosomal abnormalities simultaneously in a single cell and to visually assess these genetic abnormalities in patient specimens. FISH-based tests use DNA probes labeled with colored fluorescent tags that bind to specific gene sequences on human chromosomes. These probes can reveal amplification of gene copy number or the rearrangement of large genetic structures, two genetic abnormalities that underlie certain cancers and other medical conditions. Abbott’s FISH-based tests include PathVysion®, which is used to detect amplification of the HER-2 gene and as an aid in determining whether a patient is an appropriate candidate for Herceptin® (trastuzumab) therapy for breast cancer, and Vysis UroVysionÔ, for monitoring for the recurrence of bladder cancer.

About BioGenex
BioGenex, a technology leader in molecular pathology, provides Total Solution for complete automation of cell and tissue testing. The company offers a broad range of reagents and systems to streamline and standardize cellular and molecular diagnostics. BioGenex’s products are designed for high throughput at a low cost of ownership, providing ease of use and maximum flexibility for clinical diagnostics, life science research, and drug discovery.

BioGenex’s news releases and other information are available at www.biogenex.com .

About Abbott Molecular Diagnostics
Abbott’s rapidly growing molecular diagnostics business provides physicians with critical information based on the early detection of pathogens and subtle changes in patients’ genes and chromosomes, allowing for earlier diagnosis, selection of appropriate therapies and monitoring of disease progression. The business includes instruments and reagents used to conduct sophisticated analysis of patient DNA and RNA.

About Abbott Laboratories
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.

Abbott’s news releases and other information are available on the company’s Web site at www.abbott.com .

For more information on BioGenex Laboratories, visit www.biogenex.com  or call 1-800-421-4149.