TwitterLinkedInFacebook Instagram
United StatesLanguage Flag

Press Release

OraQuick Rapid HIV-1 Antibody Test Receives Gold Medical Design Excellence Award

June 6, 2003 at 6:01 AM EDT

BETHLEHEM, Pa.--(BUSINESS WIRE)--June 6, 2003--OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader in oral fluid diagnostics, announced today that its OraQuick(R) Rapid HIV-1 Antibody Test has received the Gold Medical Design Excellence Award in the "In Vitro Diagnostics" category in the sixth annual Medical Design Excellence Awards (MDEA) competition. The Gold Award, a top award in its category, was announced on June 3, 2003, at the Medical Design & Manufacturing East Exposition and Conference in New York City.

OraQuick(R) is the first FDA-approved rapid, point-of-care test designed to detect antibodies to HIV-1 in finger-stick whole blood within approximately 20 minutes. OraSure received FDA approval of the OraQuick(R) test on November 7, 2002. On January 31, 2003, OraSure received a CLIA (Clinical Laboratory Improvements Amendments of 1988) waiver for the test, permitting its use by more than 180,000 sites in the United States, including outreach clinics, community-based organizations and physicians' offices.

The MDEA competition is the only awards program that exclusively recognizes contributions and advances in the design of medical products. Entries are evaluated on the basis of design and engineering features, including innovative functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability of the product development team to overcome design and engineering challenges so the product meets its clinical objectives.

"This award validates the collaborative efforts of our research and development, manufacturing, regulatory and quality groups, who were responsible for bringing the OraQuick(R) Rapid HIV-1 test to the market," said Mike Gausling, Chief Executive Officer of OraSure Technologies. "The commitment and expertise of our team has been the driving factor behind OraSure's long history of innovation in the diagnostic industry."

A comprehensive review of entries in the MDEA competition was performed by an impartial, multidisciplinary panel with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics.

The 2003 MDEA winners were honored at a ceremony during the Medical Design & Manufacturing East Conference and Exposition, held June 2 - 4, 2003, at New York City's Jacob K. Javits Convention Center. The MDEA Awards are sponsored by Canon Communications LLC, the leading publisher and tradeshow producer serving the worldwide medical device industry, and Medical Device & Diagnostic Industry, the program's sponsoring publication.

About OraSure Technologies

OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies and diagnostic products, including immunoassays and other in vitro diagnostic tests and other medical devices. These products are sold in the United States and certain foreign countries to various distributors, government agencies, clinical laboratories, physicians' offices, hospitals, and commercial and industrial entities.

OraSure Technologies is the leading supplier of oral-fluid collection devices and assays to the life insurance industry and public health markets for the detection of antibodies to HIV-1. In addition, the Company supplies oral-fluid testing solutions for drugs of abuse testing. For more information on the Company, please go to www.orasure.com.


    CONTACT: OraSure Technologies, Inc.
             Investor Contact:
             Ronald H. Spair, 610/882-1820
             Investorinfo@orasure.com www.orasure.com
                 or
             Media Contact:
             William Bruckner, 610/882-1820
             wbruckner@orasure.com

    SOURCE: OraSure Technologies, Inc. 
© OraSure Technologies., 2024