LabCorp Announces the Availability of the CDC Zika MAC-ELISA Test
August 02 2016 - 12:45PM
Business Wire
The CDC Zika MAC-ELISA Test Has Received FDA
Emergency Use Authorization and Complements the RealStar® Zika
Virus RT-PCR Kit U.S.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH)
today announced the nationwide availability of testing for Zika
virus using the Zika Immunoglobulin M (IgM) Antibody Capture
Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) developed by the
Centers for Disease Control and Prevention (CDC). The test received
Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration (FDA), initially on February 26, 2016, and reissued
on June 29, 2016, for the qualitative detection of Zika virus IgM
antibodies in serum or cerebrospinal fluid (collected alongside a
patient-matched serum specimen), and is being made available for
the first time to commercial laboratories. It is intended to be
used in the diagnosis of Zika virus infection in individuals
meeting clinical and/or epidemiological criteria established by CDC
for Zika virus infection risk.
“Zika virus continues to be a serious public health threat, and
we are pleased to be among the first commercial laboratories to
make the Zika MAC-ELISA test available to physicians for patients
who meet CDC criteria for testing,” said David P. King, LabCorp’s
chairman and chief executive officer. “This test enhances our
offering in infectious diseases and can help to improve health and
lives.”
CDC clinical criteria for Zika virus infection testing include a
history of clinical signs and symptoms associated with Zika virus
infection. CDC epidemiological criteria for Zika virus infection
testing include a recent history of travel to a geographic region
with active Zika virus transmission at the time of travel, or other
epidemiologic criteria for which Zika virus testing may be
indicated as part of a public health response.
Zika virus, which is primarily spread through Aedes aegypti
mosquito bites and can also be spread through sexual contact
without a barrier method, and from mother to fetus, has been
identified in 1,658 individuals in the U.S. as of July 27, 2016.
All but one of those cases were associated with travel to areas
with ongoing transmission of Zika virus or an epidemiological link
with a person with such travel history (one was a laboratory
exposure). More recently, officials have confirmed the first known
cases in the continental United States of local mosquito-borne Zika
virus transmission in Miami, Florida Public health officials have
determined that Zika virus poses a potential public health
emergency.
Most cases of Zika virus infection are relatively minor, and
those infected may exhibit no symptoms or mild symptoms such as
fever, joint pain, rash or redness of the eyes. However, Zika virus
infection during pregnancy can cause birth defects, including fetal
microcephaly, and may also contribute to other poor pregnancy
outcomes, including stillbirth or miscarriage. Women who are
exposed to Zika virus or diagnosed with Zika virus infection during
pregnancy, or who become pregnant from a partner who has been
exposed or diagnosed, should monitor their pregnancy closely with
their healthcare provider.
The Zika MAC-ELISA testing is clinically appropriate for use in
indicated persons during the period beginning soon after the onset
of symptoms through approximately 12 weeks following infection and
is intended for use in serum or cerebrospinal fluid when submitted
with a patient-matched serum sample. By comparison, RT-PCR tests
for Zika virus are clinically appropriate as a primary test only up
to the first 7 to 14 days after the onset of symptoms, depending on
the sample type tested. The RealStar® Zika Virus RT-PCR Kit U.S.,
which is offered by LabCorp and is tested on urine paired with
serum, is clinically appropriate up to the first 7 days following
infection. Current CDC recommendations for Zika laboratory testing
can be found at
http://www.cdc.gov/zika/laboratories/lab-guidance.html.
This test has not been FDA cleared or approved. This test has
been authorized by FDA under an EUA for use by authorized
laboratories and is only authorized for the duration of the
declaration that circumstances exist justifying the EUA, unless the
authorization is terminated or revoked sooner. It is authorized
only for the detection of Zika virus infection and not for any
other viruses or pathogens. As required by FDA, LabCorp will report
all equivocal and presumptive positive results of this test to CDC
and other public health authorities, as may be appropriate. LabCorp
will also report to CDC any suspected occurrence of false negative
results and significant deviations from the established performance
characteristics of which it becomes aware.
About LabCorp®
Laboratory Corporation of America® Holdings, an S&P 500
company, is the world’s leading healthcare diagnostics company,
providing comprehensive clinical laboratory services through
LabCorp Diagnostics, and end-to-end drug development support
through Covance Drug Development. LabCorp is a pioneer in
commercializing new diagnostic technologies and is improving
people’s health by delivering the combination of world-class
diagnostics, drug development services and technology-enabled
solutions. With net revenue in excess of $8.5 billion in 2015 and
more than 50,000 employees in approximately 60 countries, LabCorp
offers innovative solutions to healthcare stakeholders. LabCorp
clients include physicians, patients and consumers,
biopharmaceutical companies, government agencies, managed care
organizations, hospitals, and clinical labs. To learn more about
Covance Drug Development, visit www.covance.com. To learn more
about LabCorp and LabCorp Diagnostics, visit www.labcorp.com.
This press release contains forward-looking statements including
with respect to estimated 2016 guidance and the impact of various
factors on operating results. Each of the forward-looking
statements is subject to change based on various important factors,
including without limitation, competitive actions in the
marketplace, adverse actions of governmental and other third-party
payers and the results from the Company’s acquisition of Covance.
Actual results could differ materially from those suggested by
these forward-looking statements. Further information on potential
factors that could affect LabCorp’s operating and financial results
is included in the Company’s Form 10-K for the year ended December
31, 2015, and subsequent Forms 10-Q, including in each case under
the heading risk factors, and in the Company’s other filings with
the SEC, as well as in the risk factors included in Covance’s
filings with the SEC. The information in this press release should
be read in conjunction with a review of the Company’s filings with
the SEC including the information in the Company’s Form 10-K for
the year ended December 31, 2015, and subsequent Forms 10-Q, under
the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS.
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Laboratory Corporation of America®
HoldingsPaul Surdez (investors) -
+1-336-436-5076Investor@labcorp.comorPattie
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www.labcorp.com
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