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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
SEPTEMBER 21, 2001
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(Date of earliest event reported)
LABORATORY CORPORATION OF AMERICA HOLDINGS
------------------------------------------
(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
Laboratory Corporation of America Holdings-Registered Trademark-
Holdings (Labcorp-Registered Trademark) (NYSE: LH) today announced that
its National Genetics Institute Inc. (NGI) had its Biologics License
applications for the UltraQual-Trademark-GCV RT-PCR and UltraQual-Trademark-
HIV-1 RT-PCR assays approved by the U.S. Food and Drug Administration (FDA).
NGI's UltraQual-Trademark_ assays for HVC and HIV-1 are the first nucleic acid
amplification tests (NAT) to be approved by the FDA for donor screening and
will result in earlier detection of HCV or HIV-1 infection in plasma donors
as well as increase the overall safety of plasma derived products. The FDA has
also approved the use of the NGI UltraQual-Trademark-HIV-1 RT-PCR assay in
combination with approved pooling algorithms as an alternative to currently
licensed HIV-1 p24 antigen tests for the screening of Source Plasma
When used in combination with FDA approved pooling and resolution algorithms,
NGI's UltraQual-Trademark- HCV RT-PCR and UltraQual-Trademark-HIV-1 RT-PCR
assays are indicated for the qualitative detection of Hepatitis C Virus (HCV)
and Human Immunodeficiency Virus, type 1 (HIV-1) nucleic acids in pools of
human Source Plasma comprised of equal aliquots of not more than 512
individual plasma samples respectively.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL
INFORMATION AND EXHIBITS
(c) Exhibit
20 Press release of the Company dated September 21, 2001.
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
------------------------------------------
(Registrant)
By:/s/ BRADFORD T. SMITH
----------------------------------
Bradford T. Smith
Executive Vice President,
General Counsel, Secretary
and Compliance Officer
Date: September 21, 2001
Laboratory Corporation of America-Registered Trademark- Holdings
358 South Main Street
Burlington, NC 27215
Telephone: 336-584-5171
FOR IMMEDIATE RELEASE
Contact:336-436-4855 Shareholder Direct: 800-LAB-0401
Pamela Sherry www.labcorp.com
Investor@labcorp.com
LABCORP'S NATIONAL GENETICS INSTITUTE RECEIVES FDA
APPROVAL FOR NUCLEIC ACID TESTS FOR HCV AND HIV-1
Burlington, NC, September 21, 2001 - Laboratory Corporation of America-
Registered Trademark- Holdings (LabCorp-Registered Trademark-) (NYSE: LH)
today announced that its National Genetics Institute Inc. (NGI) had its
Biologics License Applications for the UltraQual-Trademark-HCV RT-PCR and
UltraQual-Trademark-HIV-1 RT-PCR assays approved by the U. S. Food and
Drug Administration (FDA). NGI's UltraQual-Trademark-assays for HCV and
HIV-1 are the first nucleic acid amplification tests (NAT) to be approved by
the FDA for donor screening and will result in earlier detection of HCV or
HIV-1 infection in plasma donors as well as increase the overall safety of
plasma derived products. The FDA has also approved the use of the NGI UltraQual-
Trademark-HIV-1 RT-PCR assay in combination with approved pooling
algorithms as an alternative to currently licensed HIV-1 p24 antigen tests for
the screening of Source Plasma.
When used in combination with FDA approved pooling and resolution
algorithms, NGI's UltraQual-Trademark- HCV RT-PCR and UltraQual-
Trademark-HIV-1 RT-PCR assays are indicated for the qualitative detection of
Hepatitis C Virus (HCV) and Human Immunodeficiency Virus, type 1 (HIV-1)
nucleic acids in pools of human Source Plasma comprised of equal aliquots of
not more than 512 individual plasma samples respectively.
"Our NGI laboratory team has once again demonstrated outstanding
scientific leadership by becoming the first clinical laboratory to have these
important assays approved by the FDA," said Myla P. Lai-Goldman, M.D.,
executive vice president, chief scientific officer and medical director.
"These tests represent a totally new and innovative approach to screening
plasma donations. In addition to enhanced product safety, these extremely
sensitive assays allow us to test large numbers of donations in a very
efficient manner when used in combination with complex pooling
algorithms. We look forward to employing these assays with Alpha
Therapeutic Corporation, which has simultaneously received approval by
the FDA to combine its pooling and resolution algorithms with
LabCorp/NGI's newly approved assays."
The first national clinical laboratory to fully embrace genomic testing,
Laboratory Corporation of America-Registered Trademark- Holdings
(LabCorp-Registered- Trademark-) has been a pioneer in commercializing
new diagnostic technologies. As a national laboratory with annual revenues
of $1.9 billion in 2000 and over 18,000 employees, the company offers more
than 4,000 clinical tests ranging from simple blood analyses to sophisticated
molecular diagnostics. Serving over 200,000 clients nationwide, LabCorp
leverages its expertise in innovative clinical testing technology with its
Centers of Excellence. The Center for Molecular Biology and Pathology, in
Research Triangle Park, North Carolina, offers state-of-the-art molecular
gene-based testing in infectious disease, oncology and genetics. Its National
Genetics Institute in Los Angeles is an industry leader in developing novel,
highly sensitive polymerase chain reaction (PCR) methods for testing
hepatitis C and other blood borne infectious agents. LabCorp's
Minneapolis-based Viro-Med offers molecular microbial testing using real
time PCR platforms, while its Center for Esoteric Testing in Burlington,
North Carolina, performs the largest volume of specialty testing in the
network. LabCorp's clients include physicians, state and federal
government, managed care organizations, hospitals, clinics, pharmaceutical
and Fortune 1000 companies, and other clinical laboratories.
Each of the above forward-looking statements is subject to change based
on various important factors, including without limitation, competitive
actions in the marketplace and adverse actions of governmental and other
third-party payors. Further information on potential factors that could
affect LabCorp's financial results is included in the Company's Form 10-
K for the year ended December 31, 2000 and subsequent SEC filings.
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