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LabOne and Epitope to Develop Oral Fluid Test for Hepatitis C.


Health/Medical Writers

LENEXA, Kan. and BEAVERTON, Ore.--(BW HealthWire)--June 26, 2000

LabOne, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
 NM:LABS) and Epitope epitope: see immunity. , Inc. (NASDAQ NM:EPTO) have signed an agreement to jointly develop and commercialize a laboratory-based oral fluid screening test for Hepatitis C Hepatitis C Definition

Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild.
 antibodies.

The new test will feature Epitope's OraSure(R)oral fluid collection device, which is currently used to test for HIV-1 antibodies and for five common drugs of abuse. The agreement covers both U.S. and international markets.

LabOne will financially contribute toward outside development and clinical study costs, and will provide laboratory-testing services with the goal of obtaining Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) approval for use in the public health markets in a year. LabOne will be the exclusive laboratory for oral fluid screening of Hepatitis C antibodies for U.S. customers using the new test for five years.

"The acceptance of oral fluid HIV testing has led to an increasing number of requests from our public health clients for an oral fluid Hepatitis C test," said Robert Thompson Robert Thompson may refer to:
  • Robert Thompson (professor), Syracuse University professor of television and popular culture
  • Robert Thompson (poker director), the Tournament Director on Celebrity Poker Showdown.
  • Robert Thompson (Soviet spy)
  • Robert B.
, president and chief executive officer of Epitope. "OraSure, as a proven alternative to blood testing for HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , has been embraced by healthcare workers as safe, effective, easy to use and convenient. An oral test for Hepatitis C will impart the same advantages because it eliminates the problems associated with the fear of needles and the danger of needle-stick injuries, and encourages greater patient participation. Hepatitis C has emerged as a significant health threat, and Epitope plans to combat it with safer and easier testing programs."

Epitope will be responsible for marketing the Hepatitis C testing kit, which includes an OraSure device, instructions for use, a return air express mailer and a patient identification form for use in returning the results. It is anticipated that negative test results will be provided to the testing site within 24 hours of receipt of the sample, and that positive results will be available within 72 hours.

"This new oral testing product will permit a more timely diagnosis and treatment. This is a rare opportunity to provide a safe, non-invasive Hepatitis C test service to a market that is asking for exactly that," commented W. Thomas Grant II, chairman, president and chief executive officer of LabOne. "We have worked for many years with Epitope on HIV testing and drugs of abuse testing, and we are pleased to collaborate once again with them on this important product."

According to the National Institutes of Allergy and Infectious Disease Infectious disease

A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions.
, nearly 4 million people carry the Hepatitis C virus
This page is for the virus. For the disease, see Hepatitis C.
The Hepatitis C virus (HCV) is a small (50 nm in size), enveloped, single-stranded, positive sense RNA virus in the family Flaviviridae.
 in the U.S., with particular prevalence among healthcare workers. Worldwide, an estimated 120 million people are infected with the Hepatitis C virus. The virus, which is highly contagious through exposure to contaminated contaminated,
v 1. made radioactive by the addition of small quantities of radioactive material.
2. made contaminated by adding infective or radiographic materials.
3. an infective surface or object.
 blood, is often silent for as long as 20 years and generally takes about six months before its presence can be detected with most tests. There is no vaccine for Hepatitis C, and active Hepatitis C begins attacking the victim's liver within the first years following exposure.

Epitope, Inc. develops, manufactures and markets medical devices and diagnostic products utilizing its proprietary oral fluid technologies for sale to public- and private-sector clients worldwide. The Company's primary focus is on the detection of HIV antibodies, with emphasis in the U.S. life insurance and global public health markets, and on the use of oral fluid testing for the detection of drugs of abuse and other analytes. In May 2000 the Company announced its intention to merge with the privately held STC STC Supplemental Type Certificate (FAA)
STC Society for Technical Communication
STC Subject to Change
STC Surf the Channel (website)
STC Sound Transmission Class
STC Singapore Turf Club
 Technologies, Inc. Epitope has filed an S-4 Registration statement related to this merger with the Securities and Exchange Commission (SEC) under the name OraSure Technologies, Inc. Copies of this document may be obtained at no charge from the SEC website at www.sec.gov.

LabOne is a national laboratory testing and information service provider with three divisions: insurance services, healthcare and substance abuse testing. The insurance services division with its ExamOne and SBSI SBSI Step by Step Interactive (Microsoft training program)
SBSI Separation by Bonding Silicon Islands (semiconductor fabrication) 
 subsidiaries provides proprietary information technologies CaseView and LabOne NET(TM), and CaseOne case management service to life and health insurance companies. These services include laboratory test results, paramedical par·a·med·i·cal
adj.
1. Of, relating to, or being a person trained to give emergency medical treatment or assist medical professionals.

2.
 examinations, attending physician statements, motor vehicle reports, background inspections and personal history interviews. LabOne's healthcare division provides medical diagnostic testing Diagnostic testing
Testing performed to determine if someone is affected with a particular disease.

Mentioned in: Von Willebrand Disease
 and related services to physicians and managed care organizations, and to benefit providers through its unique Lab Card(R) employee benefit program. The healthcare division's disease management reporting is specifically designed to provide managed care clients with HEDIS HEDIS Health Plan Employer Data & Information Set Managed care An initiative by the National Committee on Quality Assurance to develop, collect, standardize, and report measures of health plan performances.  data necessary for their NCQA NCQA National Committee on Quality Assurance, see there  accreditation. The company's substance abuse testing division provides drug testing services to Fortune 1000 employers and markets Intercept(TM), the oral fluid drug test, in the workplace drug testing market. The company's web site is located at www.LabOne.com.

This press release may contain "forward-looking statements," as well as historical information. Forward-looking statements include projections, statements of plans and objectives, statements of future economic performance and statements of assumptions underlying such statements. Forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause actual results to differ materially from those that may be expressed or implied in such forward-looking statements, including, but not limited to, the volume and pricing of laboratory tests performed by LabOne, competition, the extent of market acceptance of the Company's testing services in the healthcare and substance abuse testing industries, general economic conditions and other factors detailed from time to time in each Company's reports and registration statements filed with the Securities and Exchange Commission.
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jun 26, 2000
Words:910
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