Abbott Laboratories Signs Agreement With Vysis for Genomic Cancer Tests

DNA-Based Tests Employ Breakthrough Technology for the Management of Breast

And Bladder Cancer



Apr 05, 2001, 01:00 ET from Abbott Laboratories

    ABBOTT PARK, Ill., April 5 /PRNewswire/ -- Abbott Laboratories today
 announced that it has entered into an agreement with Vysis, Inc.
 (Nasdaq: VYSI) of Downers Grove, Ill., for the worldwide distribution of two
 genomic tests to assist in the management of breast and bladder cancer.
     The agreement initially gives Abbott exclusive distribution rights in
 North America and Europe for two of Vysis' DNA-based cancer tests:
 PathVysion(TM) HER-2 assay, used to detect and quantify the HER-2 gene in
 breast cancer patients, and the Vysis UroVysion(TM) 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/Pacific (except Japan) and South America for both assays.
     PathVysion, which received U.S. Food and Drug Administration (FDA)
 marketing clearance in 1998, and Vysis UroVysion, which is pending FDA
 clearance, are based upon Vysis' proprietary fluorescence in situ
 hybridization (FISH) DNA probe technology used to detect an increased number
 of genes or chromosomes.
     "The PathVysion and Vysis UroVysion assays offer great potential for
 improving the medical treatment and care of patients with breast or bladder
 cancer," said Thomas D. Brown, senior vice president, diagnostic operations,
 Abbott Laboratories. "They are important additions to Abbott's growing
 portfolio of molecular diagnostic tests, and represent significant advances in
 the increasingly important field of genomic testing."
     "It is becoming increasingly clear that abnormalities in the number of
 chromosomes and genes are a significant early event in the cancer process,"
 said John Bishop, president and CEO of Vysis. "The FISH technology platform is
 uniquely positioned to detect these abnormalities easily and cost effectively
 in routine clinical laboratories."
     To extend the use of PathVysion as an aid in the assessment of patients
 for whom treatment is being considered, Vysis is collaborating with Hoffmann-
 La Roche Inc. and Genentech, Inc., the developers and marketers of
 Herceptin(TM), a monoclonal antibody treatment for metastatic breast cancer.
 The test may provide more accurate identification of patients likely to
 respond to Herceptin therapy.
     "Determination of HER-2 gene status is one of the first major examples of
 the use of a genomic target for identifying patient populations that are most
 likely to benefit from particular therapies," said Bishop.
     According to the American Cancer Society (ACS) and EUCAN, a data base of
 European cancer statistics, it is estimated that there will be approximately
 180,000 and 200,000 new cases of breast cancer diagnosed in 2001 in the United
 States and Europe, respectively.  Determination of HER-2 status has emerged as
 the standard of care in the assessment of breast cancer cases worldwide.
     Bladder cancer is also a leading site of cancer worldwide.  According to
 the ACS and EUCAN, it is estimated that there will be approximately 60,000 and
 75,000 new cases diagnosed in 2001 in the United States and Europe,
 respectively.  In addition, there are approximately 1.4 million bladder cancer
 patients in the U.S. and Europe combined that are being routinely monitored
 for recurrence of the disease.
     Vysis, Inc. is a genomic disease management company that develops,
 commercializes and markets clinical products that provide information critical
 to the evaluation and management of cancer, prenatal disorders and other
 genetic diseases.  More information is available on the company's Web site at
 www.vysis.com .
     Abbott Laboratories is a global, diversified health care company devoted
 to the discovery, development, manufacture and marketing of pharmaceuticals,
 nutritionals, and medical products, including devices and diagnostics.  The
 company employs approximately 70,000 people and markets its products in more
 than 130 countries.  In 2000, the company's sales and net earnings were
 $13.7 billion and $2.8 billion, respectively, with diluted earnings per share
 of $1.78.
     Abbott's news releases and other information are available on the
 company's Web site at www.abbott.com .
 
 

SOURCE Abbott Laboratories
    ABBOTT PARK, Ill., April 5 /PRNewswire/ -- Abbott Laboratories today
 announced that it has entered into an agreement with Vysis, Inc.
 (Nasdaq: VYSI) of Downers Grove, Ill., for the worldwide distribution of two
 genomic tests to assist in the management of breast and bladder cancer.
     The agreement initially gives Abbott exclusive distribution rights in
 North America and Europe for two of Vysis' DNA-based cancer tests:
 PathVysion(TM) HER-2 assay, used to detect and quantify the HER-2 gene in
 breast cancer patients, and the Vysis UroVysion(TM) 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/Pacific (except Japan) and South America for both assays.
     PathVysion, which received U.S. Food and Drug Administration (FDA)
 marketing clearance in 1998, and Vysis UroVysion, which is pending FDA
 clearance, are based upon Vysis' proprietary fluorescence in situ
 hybridization (FISH) DNA probe technology used to detect an increased number
 of genes or chromosomes.
     "The PathVysion and Vysis UroVysion assays offer great potential for
 improving the medical treatment and care of patients with breast or bladder
 cancer," said Thomas D. Brown, senior vice president, diagnostic operations,
 Abbott Laboratories. "They are important additions to Abbott's growing
 portfolio of molecular diagnostic tests, and represent significant advances in
 the increasingly important field of genomic testing."
     "It is becoming increasingly clear that abnormalities in the number of
 chromosomes and genes are a significant early event in the cancer process,"
 said John Bishop, president and CEO of Vysis. "The FISH technology platform is
 uniquely positioned to detect these abnormalities easily and cost effectively
 in routine clinical laboratories."
     To extend the use of PathVysion as an aid in the assessment of patients
 for whom treatment is being considered, Vysis is collaborating with Hoffmann-
 La Roche Inc. and Genentech, Inc., the developers and marketers of
 Herceptin(TM), a monoclonal antibody treatment for metastatic breast cancer.
 The test may provide more accurate identification of patients likely to
 respond to Herceptin therapy.
     "Determination of HER-2 gene status is one of the first major examples of
 the use of a genomic target for identifying patient populations that are most
 likely to benefit from particular therapies," said Bishop.
     According to the American Cancer Society (ACS) and EUCAN, a data base of
 European cancer statistics, it is estimated that there will be approximately
 180,000 and 200,000 new cases of breast cancer diagnosed in 2001 in the United
 States and Europe, respectively.  Determination of HER-2 status has emerged as
 the standard of care in the assessment of breast cancer cases worldwide.
     Bladder cancer is also a leading site of cancer worldwide.  According to
 the ACS and EUCAN, it is estimated that there will be approximately 60,000 and
 75,000 new cases diagnosed in 2001 in the United States and Europe,
 respectively.  In addition, there are approximately 1.4 million bladder cancer
 patients in the U.S. and Europe combined that are being routinely monitored
 for recurrence of the disease.
     Vysis, Inc. is a genomic disease management company that develops,
 commercializes and markets clinical products that provide information critical
 to the evaluation and management of cancer, prenatal disorders and other
 genetic diseases.  More information is available on the company's Web site at
 www.vysis.com .
     Abbott Laboratories is a global, diversified health care company devoted
 to the discovery, development, manufacture and marketing of pharmaceuticals,
 nutritionals, and medical products, including devices and diagnostics.  The
 company employs approximately 70,000 people and markets its products in more
 than 130 countries.  In 2000, the company's sales and net earnings were
 $13.7 billion and $2.8 billion, respectively, with diluted earnings per share
 of $1.78.
     Abbott's news releases and other information are available on the
 company's Web site at www.abbott.com .
 
 SOURCE  Abbott Laboratories