Vysis Receives FDA Clearance for AneuVysion(R) Prenatal Test 510K Amendment Allowing Immediate Use of Test Results

Prenatal FISH Test Provides Highly Accurate Results for Selected Chromosomal

Abnormalities in 24 Hours



Apr 18, 2001, 01:00 ET from Vysis, Inc.

    DOWNERS GROVE, Ill., April 18 /PRNewswire/ -- Vysis, Inc. (Nasdaq: VYSI),
 a developer and marketer of DNA-based clinical products, today announced that
 FDA clearance has been received for its AneuVysion prenatal testing product
 allowing immediate reporting of test results. The previous medical policy
 indicated that test results based on Fluorescent In-Situ Hybridization (FISH)
 be withheld until routine cytogenetic test results were also available,
 generally 7-10 days later, except in medically urgent situations.  This new
 use of the Vysis AneuVysion prenatal test, allowing immediate use of results,
 was brought about by the December 2000 change in the medical policy for
 prenatal testing from the American College of Medical Genetics and the
 American Association of Human Genetics in acknowledgment that prenatal test
 results as determined by the FISH technology, used in the AneuVysion test,
 were highly accurate and reliable. The AneuVysion prenatal test can provide
 results in 24 hours with an accuracy of 99.9%.
     "The recognition of the accuracy and reliability of our AneuVysion
 prenatal test is a major immediate benefit to patients who have received
 abnormal triple screen or ultrasound results.  Rather than having to wait up
 to two anxiety filled weeks to receive results and determine the medical
 options appropriate for them, such patients can now receive and utilize
 AneuVysion test results for key chromosomal abnormalities in as little as
 24 hours," said John Bishop Vysis president and chief executive officer.
     The AneuVysion Prenatal test detects abnormalities of chromosomes X, Y,
 13, 18, 21, which represent 80-85% of the clinically significant chromosomal
 abnormalities causing mental retardation and other birth defects.  DNA probes
 specific to the chromosomes are placed in fetal cells obtained from the
 amniotic fluid of the mother via a procedure referred to as amniocentesis.
 Approximately 700,000 amniocentesis procedures are performed each year in the
 United States and Western Europe representing an annual market opportunity of
 approximately $45 million for the AneuVysion product.
     Vysis, Inc. of Downers Grove Ill., is a genomic disease management company
 that develops, commercializes and markets DNA-based clinical products
 providing information critical to the evaluation and management of cancer,
 prenatal disorders and other genetic diseases. The company has direct sales
 operations in the United States and Europe, a marketing partnership in Japan
 with Fujisawa Pharmaceutical Co., and a worldwide distribution network.
 
     The statements in this press release concerning Vysis' future financial
 results as well as any other statements which are not historical facts, are
 forward-looking statements and are subject to risks and uncertainties inherent
 in the company's business.  These risks and uncertainties, which could cause
 actual results to differ materially from those expressed or implied by
 forward-looking statements, include: The market acceptance of the company's
 clinical products; the extent to which the clinicians or laboratories
 performing the procedures with the company's products are able to obtain
 third-party reimbursement; the ability of the company to successfully market
 and sell its clinical products, other products and equipment; competition;
 compliance by the company with regulatory requirements and the timely receipt
 of necessary governmental approvals; the company's ability to manufacture
 products in sufficient quantities; the company's ability to maintain
 intellectual property protection for its proprietary products, to defend its
 existing intellectual property rights from challenges by third parties, and to
 avoid infringing intellectual property rights of third parties; and the
 company's cost control efforts. In addition, a detailed discussion of risks
 and uncertainties may be found in the company's periodic filings with the
 Securities and Exchange Commission.  Vysis disclaims any intent or obligation
 to update these forward-looking statements.
 
     Sources:
     ACMG/ASHG position statement. Genetics in Medicine. 2000;2(6):356-361.
     ACMG/ASHG position statement. Am J Hum Genet. 1993;53:526-527.
 
     To receive Vysis, Inc.'s latest news release and other corporate
 documents, free of charge via fax, simply dial 1-800-PRO-INFO.  Use company
 ticker VYSI.
 
 
 

SOURCE Vysis, Inc.
    DOWNERS GROVE, Ill., April 18 /PRNewswire/ -- Vysis, Inc. (Nasdaq: VYSI),
 a developer and marketer of DNA-based clinical products, today announced that
 FDA clearance has been received for its AneuVysion prenatal testing product
 allowing immediate reporting of test results. The previous medical policy
 indicated that test results based on Fluorescent In-Situ Hybridization (FISH)
 be withheld until routine cytogenetic test results were also available,
 generally 7-10 days later, except in medically urgent situations.  This new
 use of the Vysis AneuVysion prenatal test, allowing immediate use of results,
 was brought about by the December 2000 change in the medical policy for
 prenatal testing from the American College of Medical Genetics and the
 American Association of Human Genetics in acknowledgment that prenatal test
 results as determined by the FISH technology, used in the AneuVysion test,
 were highly accurate and reliable. The AneuVysion prenatal test can provide
 results in 24 hours with an accuracy of 99.9%.
     "The recognition of the accuracy and reliability of our AneuVysion
 prenatal test is a major immediate benefit to patients who have received
 abnormal triple screen or ultrasound results.  Rather than having to wait up
 to two anxiety filled weeks to receive results and determine the medical
 options appropriate for them, such patients can now receive and utilize
 AneuVysion test results for key chromosomal abnormalities in as little as
 24 hours," said John Bishop Vysis president and chief executive officer.
     The AneuVysion Prenatal test detects abnormalities of chromosomes X, Y,
 13, 18, 21, which represent 80-85% of the clinically significant chromosomal
 abnormalities causing mental retardation and other birth defects.  DNA probes
 specific to the chromosomes are placed in fetal cells obtained from the
 amniotic fluid of the mother via a procedure referred to as amniocentesis.
 Approximately 700,000 amniocentesis procedures are performed each year in the
 United States and Western Europe representing an annual market opportunity of
 approximately $45 million for the AneuVysion product.
     Vysis, Inc. of Downers Grove Ill., is a genomic disease management company
 that develops, commercializes and markets DNA-based clinical products
 providing information critical to the evaluation and management of cancer,
 prenatal disorders and other genetic diseases. The company has direct sales
 operations in the United States and Europe, a marketing partnership in Japan
 with Fujisawa Pharmaceutical Co., and a worldwide distribution network.
 
     The statements in this press release concerning Vysis' future financial
 results as well as any other statements which are not historical facts, are
 forward-looking statements and are subject to risks and uncertainties inherent
 in the company's business.  These risks and uncertainties, which could cause
 actual results to differ materially from those expressed or implied by
 forward-looking statements, include: The market acceptance of the company's
 clinical products; the extent to which the clinicians or laboratories
 performing the procedures with the company's products are able to obtain
 third-party reimbursement; the ability of the company to successfully market
 and sell its clinical products, other products and equipment; competition;
 compliance by the company with regulatory requirements and the timely receipt
 of necessary governmental approvals; the company's ability to manufacture
 products in sufficient quantities; the company's ability to maintain
 intellectual property protection for its proprietary products, to defend its
 existing intellectual property rights from challenges by third parties, and to
 avoid infringing intellectual property rights of third parties; and the
 company's cost control efforts. In addition, a detailed discussion of risks
 and uncertainties may be found in the company's periodic filings with the
 Securities and Exchange Commission.  Vysis disclaims any intent or obligation
 to update these forward-looking statements.
 
     Sources:
     ACMG/ASHG position statement. Genetics in Medicine. 2000;2(6):356-361.
     ACMG/ASHG position statement. Am J Hum Genet. 1993;53:526-527.
 
     To receive Vysis, Inc.'s latest news release and other corporate
 documents, free of charge via fax, simply dial 1-800-PRO-INFO.  Use company
 ticker VYSI.
 
 
 SOURCE  Vysis, Inc.