The first at-home mpox testing kit provides
patients with convenience and privacy to test for mpox, supports
physicians in detection and treatment
BURLINGTON, N.C., April 10,
2024 /PRNewswire/ -- Labcorp (NYSE: LH), a
global leader of innovative and comprehensive laboratory services,
announced today the U.S. Food and Drug Administration (FDA) has
granted Emergency Use Authorization (EUA) for its Mpox PCR
Test Home Collection Kit to aid in the diagnosis of infection with
non-variola Orthopoxvirus, including the monkeypox virus that
causes monkeypox, also known as mpox. The test is the first mpox
at-home collection kit authorized by FDA and is available to
physicians to order for patients 18 years of age or older who are
suspected of mpox infection.
"The FDA's emergency authorization of Labcorp's Mpox PCR Test
Home Collection Kit will enable us to play a vital role within the
healthcare community in the early detection and management of
mpox," said Dr. Brian Caveney,
Labcorp's chief medical and scientific officer. "The collection kit
reflects our ongoing commitment to providing critical diagnostic
tools to physicians and accessible and convenient testing options
to patients."
Physicians can order a test through Labcorp's provider interface
platform for patients they suspect may be infected with the virus.
Labcorp will send the test kit directly to patients for at-home
collection. The kit includes detailed instructions for patients on
correctly collecting a lesion swab, securing the sample in the
provided collection tube, and preparing the package for return to
an authorized laboratory for analysis.
Testing of specimens collected using the test kit will employ
PCR (polymerase chain reaction) technology and will be conducted in
authorized laboratories designated by Labcorp and certified under
the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to
meet the requirements for performing high-complexity testing
criteria for the detection of non-variola Orthopoxvirus DNA.
Results are electronically delivered to the prescribing physician
and made available to the patient in Labcorp's patient portal at
patient.labcorp.com. The company also aims to make the test
available on its Labcorp OnDemand platform.
The authorization comes amid reported increases in mpox cases in
the United States. According to
the Centers for Disease Control and Prevention (CDC), there have
been 511 mpox cases reported in 2024 through March 16, compared to fewer than 300 cases
reported by late March 2023. Since
the onset of the national 2022-2023 mpox virus outbreak, part of a
larger global outbreak of human mpox caused by the West African
clade of the monkeypox virus, the CDC notes more than 32,000 cases
and 58 deaths have been reported nationally.
To learn more, visit
https://www.labcorp.com/infectious-disease/mpox.
This product has not been FDA cleared or approved, but has been
authorized for emergency use by FDA under an EUA. This
product has been authorized only for the collection and maintenance
of lesion swab specimens as an aid in detection of nucleic acid
from non-variola Orthopoxvirus, including monkeypox virus, not for
any other viruses or pathogens. The emergency use of this product
is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of infection
with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus,
under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is
terminated or authorization is revoked sooner.
About Labcorp
Labcorp (NYSE: LH) is a global leader of
innovative and comprehensive laboratory services that helps
doctors, hospitals, pharmaceutical companies, researchers and
patients make clear and confident decisions. We provide insights
and advance science to improve health and improve lives through our
unparalleled diagnostics and drug development laboratory
capabilities. The company's more than 67,000 employees serve
clients in approximately 100 countries, provided support for 84% of
the new drugs and therapeutic products approved in 2023 by the FDA,
and performed more than 600 million tests for patients around the
world. Learn more about us at www.labcorp.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements,
including, but not limited to statements with respect to the
expected future availability of its services and
products.
Each of the forward-looking statements is subject to change
based on various important factors, many of which are beyond the
company's control. These factors, in some cases, have affected and
in the future (together with other factors) could affect the
company's ability to implement the company's business strategy, and
actual results could differ materially from those suggested by
these forward-looking statements. As a result, readers are
cautioned not to place undue reliance on any of the forward-looking
statements.
The company has no obligation to provide any updates to these
forward-looking statements even if its expectations change. All
forward-looking statements are expressly qualified in their
entirety by this cautionary statement. Further information on
potential factors, risks and uncertainties that could affect
operating and financial results is included in the company's most
recent Annual Report on Form 10-K and subsequent Forms 10-Q,
including in each case under the heading RISK FACTORS, and in the
company's other filings with the SEC. The information in this press
release should be listened to in conjunction with a review of the
company's filings with the SEC including the information in the
company's most recent Annual Report on Form 10-K, and subsequent
Forms 10-Q, under the heading "MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS"
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SOURCE Labcorp