Abbott Laboratories/Vysis: agreement for cancer tests

US based company Vysis, a genomic disease management company, and Abbott laboratories have entered into an agreement for the worldwide distribution of DNA-based genomic tests for breast and bladder cancer. The deal will expand Abbott's oncology diagnostics portfolio and provide Vysis with the opportunity for worldwide recognition in this area.

The agreement between Vysis and Abbott Laboratories initially gives Abbott exclusive distribution rights in North America and Europe for two of Vysis' DNA-based cancer tests; PathVysion HER-2 assay, used to detect and quantify the HER-2 gene in breast cancer patients, and the Vysis UroVysion assay, which detects genetic changes in bladder cancer cells found in the urine. The agreement also gives Abbott an exclusive option for distribution rights in Asia. PathVysion and Vysis UroVysion are technologies based upon a fluorescence activated DNA probe technology capable of detecting an increased number of genes or chromosomes. Both PathVysion and Vysis UroVysion assays offer significant potential for improving the medical treatment and care of patients with breast or bladder cancer.

Representing important additions to Abbott's growing portfolio of molecular diagnostic tests, the technologies are significant advances in the increasingly important field of genomic testing. The discovery of abnormalities in the number of chromosomes and genes represent significant early events in the cancer process. The technology platform employed is uniquely positioned to detect these abnormalities easily and cost effectively in routine clinical laboratories. The test may also provide more accurate identification of patients likely to respond to Herceptin therapy. As one of the first major examples of the use of a genomic target for identifying patient populations, determination of HER-2 gene status represents an especially promising therapy area.

With approximately 180,000 and 200,000 new cases of breast cancer expected to be diagnosed during 2001 in the United States and Europe respectively, patient potential is considerable. Especially as determination of HER-2 status is emerging as the standard in the assessment of breast cancer cases worldwide. Bladder cancer is also a leading site of cancer worldwide with approximately 60,000 and 75,000 new cases expected to be diagnosed during 2001 in the United States and Europe respectively. Overall the agreement signals a move that will benefit both companies, enabling Abbott to expand its current oncology diagnostics portfolio and providing Vysis with the opportunity for worldwide recognition within this field.