FDA Approval Allows Bio-Reference Laboratories to Begin Marketing Visible Genetics Gene-Based Testing: Visible Genetics Receives FDA Approval For HIV Drug Resistance Testing Business Wire
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FDA Approval Allows Bio-Reference Laboratories to Begin Marketing Visible Genetics Gene-Based Testing: Visible Genetics Receives FDA Approval For HIV Drug Resistance Testing

Business Wire - September 28, 2001


ELMWOOD PARK, N.J.--(BW HealthWire)--Sept. 28, 2001-- Bio-Reference Laboratories, Inc. (NASDAQ: BRLI) announced today that it will begin marketing the Visible Genetics TRUGENE(TM) HIV-1 Genotyping Test.

Visible Genetics Inc. (VGI, NASDAQ: VGIN) announced on Wednesday that it has received clearance from the U.S. Food and Drug Administration (FDA) to commercially market the product for clinical use. This approval allows Bio-Reference and VGI to commence marketing this product to physicians and healthcare professionals who treat HIV patients. Pursuant to a previously announced preferred marketing agreement, Bio-Reference Laboratories and VGI have a preferred marketing partnership that will allow Bio-Reference to market the product and to be the local reference and overflow laboratory for the test in the New York Metropolitan area. The FDA clearance is considered a significant advance in the battle against HIV since it will provide treating physicians with a reliable, accurate and easy-to-use diagnostic tool to aid in therapeutic drug selection.

Under the terms of the preferred marketing agreement Bio-Reference and Visible Genetics will co-market and support the product in New York, New Jersey and the Greater Philadelphia area, and provide a comprehensive joint marketing program which will include physician and patient education. Additionally, the two companies will work together to identify, develop and secure primary payor contracts and policy procedures.

Marc Grodman, MD, President, CEO and Chairman of the Board of Bio-Reference, noted, "Now that VGI has received FDA clearance for us to market this product, Bio-Reference can commence providing the test to our customers as well as make it available to all healthcare providers who treat AIDS patients. It is estimated that there are 350,000 AIDS patients in the country today. It is further estimated that 30% to 35% of those patients are in the greater New York-Philadelphia metropolitan area or are cared for in correctional facilities. Bio-Reference has an extremely strong presence in both markets. We serve the New York Metropolitan area where there is an extremely large AIDS community that will benefit greatly from this superior testing capability. We have announced for some time that we have been actively developing our prison healthcare business; we provide laboratory services to some of the largest prison populations in the country and we are constantly seeking to expand this market penetration. The prison population is probably one of the largest single segments of society effected by AIDS and this testing procedure will be of tremendous value in treating and controlling the spread of AIDS within this population. Although this test is costly, we believe that its efficacy in treating AIDS patients has already been demonstrated."

Dr. Grodman continued: "Our direct sales marketing force has enabled us to sustain twenty percent compound annual growth rates for over six years now. They are an effective, dynamic group who understand advanced technology and will assure its delivery to the groups most in need of this testing. We look forward to working with VGI and together we will increase market awareness for this impressive methodology and we will educate the public, the payors and the regulators of the need and benefits of this advanced testing procedure."

About Bio-Reference Laboratories, Inc.

The Company is the largest independent regional clinical laboratory in the Northeast and has major market positions in physician offices, nursing homes and correctional institutions. The Company's wholly owned subsidiary, CareEvolve, is a physician-centric connectivity solution that seeks to enhance physician-patient and physician-payor electronic communications on a secure basis, including communicating laboratory results, e-mail, prescriptions, payor verification and eligibility, as well as offering many other value-added Internet based services to its physician members. PSIMedica, a business unit of the Company, is a clinical knowledge management (CKM) organization offering an array of information solutions for reducing healthcare costs and improving quality performance.

This press release contains certain "forward-looking" statements, as defined in the United States Private Securities Litigation Reform Act of 1995, that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. Such factors are detailed from time to time in the Company's filings with the regulatory authorities having jurisdiction.

You may register to receive Bio-Reference Laboratories' future press releases or to download a complete Digital Investor Kit(TM) including press releases, regulatory filings and corporate materials by clicking on the "Digital Investor Kit(TM)" icon at www.kcsa.com.

CONTACT: Bio-Reference Laboratories, Inc., Elmwood Park

Marc D. Grodman, 201/791-2600

Fax: 201/791-1941

mgrodman@bioreference.com or

KCSA Public Relations Worldwide, New York

Sarah Shepard, 212/896-1236

sshepard@kcsa.com

Michael Cimini, 212/896-1233

mcimini@kcsa.com

www.kcsa.com

SOURCE: Bio-Reference Laboratories, Inc.


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