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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934
JUNE 30, 1998
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(Date of earliest event reported)
LABORATORY CORPORATION OF AMERICA HOLDINGS
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(Exact name of registrant as specified in its charter)
DELAWARE 1-11353 13-3757370
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification
incorporation) Number)
358 SOUTH MAIN STREET, BURLINGTON, NORTH CAROLINA 27215
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(Address of principal executive offices)
336-229-1127
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(Registrant's telephone number, including area code)
ITEM 5. OTHER EVENTS
On June 30, 1998, the Company issued a press release
announcing that the Antivirogram-TM- and the VircoGEN-TM-, two new
diagnostic testing procedures enabling physicians to
evaluate resistance of HIV to antiretroviral drugs, will be
available for commercial use on July 20, 1998 exclusively
from LabCorp facilities in the U.S. These new testing
systems are an important advance in optimizing treatment
choices in the fight against HIV/AIDS.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL
INFORMATION AND EXHIBITS
(c) Exhibit
20 Press release of the Company dated June 30, 1998.
SIGNATURES
Pursuant to the requirements of the Securities and
Exchange Act of 1934, the registrant has duly caused this
report to be signed on its behalf by the undersigned
hereunto duly authorized.
LABORATORY CORPORATION OF AMERICA HOLDINGS
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(Registrant)
By:/s/ BRADFORD T. SMITH
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Bradford T. Smith
Executive Vice President,
General Counsel, Secretary
and Compliance Officer
Date: July 7, 1998
INVESTORS CONTACT: PAMELA SHERRY
336.584.5171, EXT. 4855
MEDIA CONTACT: HAYLEY SOFFER, MS&L SARRA SCHAAB, MS&L
IN GENEVA JUNE 27 - JULY 2 (IN NEW YORK)
MOBILE: 79.221.78.02 PHONE:212.213.7056
PHONE: 212.213.7067
HIV DRUG RESISTANCE TESTING PROCEDURES
TO BE INTRODUCED IN THE UNITED STATES
--CLINICAL TRIALS INDICATE RESISTANCE TESTING PREDICTS
EFFECTIVENESS OF DRUG THERAPY--
Geneva, Switzerland, June 30, 1998 - Laboratory Corporation of America-
Registered Trademark-Holdings (LabCorp-Registered Trademark-) (NYSE:LH) and
VIRCO, today announced that the Antivirogram-TM-and the VircoGEN-TM-, two new
diagnostic testing procedures enabling physicians to evaluate resistance of
HIV to antiretroviral drugs, will be available for commercial use on July 20
exclusively from LabCorp facilities in the U. S. These new testing systems
are an important advance in optimizing treatment choices in the fight against
HIV/AIDS.
"Testing resistance in the clinical setting empowers physicians and patients
to make rational decisions about drug therapy," said John Mellors, M.D.
director of the AIDS Program, University of Pittsburgh Medical Center.
"Knowing which medications are most likely to be effective against the HIV
virus prior to treatment permits us to make better informed choices."
Data presented at the 12th World AIDS Conference in Geneva shows a promising
indication of the testing systems' ability to predict response to therapy.
Collectively, various presentations including more than 2,000 isolates were
presented in Geneva and at the 2nd International Workshop on HIV Drug
Resistance and Treatment Strategies in Lake Maggiore, Italy. An expanded
clinical validation program is ongoing.
In outcomes studies using the Antivirogram-TM- and VircoGEN-TM-, physicians
were able to predict antiviral response in antiretroviral experienced
patients. One study done in collaboration with the British Columbia Centre
for Excellence in HIV/AIDS of 84 patients with extensive prior nucleoside
experience, found that patients with "sensitive" virus, as indicated by
phenotypic testing, (sensitivity being defined as the ability of drugs to
inhibit the virus) were twelve times more likely to respond to
ritonavir/saquinavir therapy.
Patients whose virus was classified "sensitive" by genotypic testing, were
four times more likely to respond to the therapy. The study included protease
inhibitor (PI)-experienced patients that were switching to the PI combination
ritonavir/saquinivir alone or in combination with other antiretroviral therapy
as salvage therapy. Phenotyping and genotyping were conducted on isolates
from these patients using the Antivirogram-TM- and VircoGEN-TM-.
"Since the partnership between VIRCO and LabCorp was announced, our team of
scientists have been working diligently to bring the Antivirogram-TM- and
VircoGEN-TM- to market," said Dr. Myla Lai-Goldman, Executive Vice President,
Chief Scientific Officer and Medical Director of LabCorp. "The data presented
validates the clinical importance of these systems and we are committed to
continuing our ongoing work to assess their broad capabilities."
To further substantiate the value of these testing procedures, a large study
of 1500 isolates collected from the patients provided an impressive data set
to correlate genotypic resistance patterns with phenotypic resistance
profiles. While genotyping examines the drug resistance mutations accumulated
by the virus and may give an important indication of the possible evolution of
resistance, phenotyping measures virus growth in the presence of a drug. When
used together, physicians can now assess how each patient is going to respond
to given therapy, thus allowing physicians to make more informed decisions
when selecting potent therapeutic regimens.
Turnaround time for the VicoGEN-TM- is five to 10 working days and three to
four weeks for the Antovirogram-TM-. LabCorp customer service will be
available to provide additional information by calling 800-533-0567.
ABOUT THE COMPANIES
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Laboratory Corporation of America-Registered Trademark- Holdings (LabCorp-
Registered Trademark-) is a national clinical laboratory organization with
revenues of $1.5 billion in 1997. The Company operates primary testing
facilities nationally, offering more than 1,700 different clinical assays,
from routine blood analyses to more sophisticated technologies. LabCorp
performs diagnostic tests and procedures for physicians, managed-care
organizations, hospitals, clinics, long-term care facilities, industrial
companies, and other clinical laboratories.
VIRCO is a privately-held high tech/molecular biology company that was founded
in 1995 by Rudi Pauwels, Ph.D. and Paul Stoffels, M.D. in Belgium, and Brendan
Larder, Ph.D. in the U.K. VIRCO specializes in genomics and bioinformatics
applied to disease management and is at the forefront of the development and
implementation of complex technologies to monitor HIV drug sensitivity in
infected persons. VIRCO's scientists have extensive experience in the field
of antiviral development and drug resistance, having performed phenotypic
resistance testing on more than 8,000 samples.