The LabCorp 2019 Novel Coronavirus (COVID-19),
NAA Test is for Use by Clinicians with Patients Who Meet COVID-19
Evaluation Criteria
LabCorp® (NYSE: LH), a leading global life sciences company that
is deeply integrated in guiding patient care, is making its LabCorp
2019 Novel Coronavirus (COVID-19), NAA test available today,
beginning at 6 p.m. ET, for ordering by physicians or other
authorized healthcare providers anywhere in the U.S. The test
detects the presence of the underlying virus that causes COVID-19
and is for use with patients who meet current guidance for
evaluation of infection with COVID-19.
“We have been intensely focused on making testing for COVID-19
available as soon as possible, working with the government and
others to address this public health crisis,” said Adam H.
Schechter, president and CEO of LabCorp. “By expanding access to
testing in the U.S., and preparing to support the development of
vaccines and treatments for COVID-19 through our Covance Drug
Development business, we are delivering on LabCorp’s mission to
improve health and improve lives.”
The LabCorp 2019 Novel Coronavirus (COVID-19), NAA test was
developed internally by LabCorp and is being made available
pursuant to guidance issued by the U.S. Food and Drug
Administration (FDA). LabCorp’s test has been validated for use
with respiratory samples, including nasopharyngeal (NP) or
oropharyngeal (OP) aspirates or washes, NP or OP swabs, and
broncheoalveolar lavage (BAL). The test is a qualitative assay
using PCR technology, which LabCorp played a central role in
commercializing when PCR was introduced nearly 30 years ago.
LabCorp does not currently collect specimens for the test.
Patients for whom testing has been ordered should not be sent to a
LabCorp location to have a specimen collected. Instead, an
appropriate specimen should be collected at the healthcare facility
where the patient was seen and the test was ordered. The specimen
should be sent to LabCorp using standard procedures. Test results
will be available in 3-4 days. More information about the test,
including specimen collection and packaging requirements, is
available here:
https://www.labcorp.com/tests/139900/2019-novel-coronavirus-covid-19-naa.
“As COVID-19 continues to spread in the U.S., having
high-quality, reliable, scalable laboratory tests available is a
critically important part of the response,” said Marcia Eisenberg,
Ph.D., chief scientific officer for LabCorp Diagnostics.
“Identifying people who are infected is necessary to make sure that
patients receive the appropriate care, to better manage the use of
healthcare resources, and to help contain the spread of the virus.
We will continue to stay closely involved in the ongoing response,
and we are prepared to expand our testing capacity to help meet
demand.”
The LabCorp 2019 Novel Coronavirus (COVID-19), NAA test is made
available pursuant to “Immediately in Effect Guidance for Clinical
Laboratories and Food and Drug Administration Staff” issued by the
FDA on February 29, 2020. Pursuant to the policy set forth in that
guidance, LabCorp is certified to perform high-complexity testing
under CLIA in compliance with CLIA requirements. The LabCorp 2019
Novel Coronavirus (COVID-19), NAA test has been developed and
validated, and is being performed by LabCorp, but FDA’s independent
review of the validation is pending. LabCorp is pursuing an EUA for
the test.
Yesterday, LabCorp joined with colleagues from the American
Clinical Laboratory Association (ACLA) for a meeting with Vice
President Pence and members of the White House’s Coronavirus Task
Force. As an industry, clinical labs have taken steps to meet the
growing demand for national testing and are part of a newly-formed
consortium working together with the Administration, the CDC and
FDA as well as state and local public health labs, hospitals and
academic medical centers.
In addition to its test for COVID-19, LabCorp is also able to
perform the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel if
needed to meet testing demand. The CDC test is for the presumptive
detection of 2019-nCoV RNA in upper and lower respiratory specimens
(such as nasopharyngeal or oropharyngeal swabs, sputum, lower
respiratory tract aspirates, bronchoalveolar lavage, and
nasopharyngeal wash/aspirate or nasal aspirate), and other
authorized specimens collected from individuals who meet CDC
criteria for COVID-19 testing. The CDC test has not been FDA
cleared or approved, has been authorized by FDA under an EUA for
use by authorized laboratories, and has been authorized only for
the detection of nucleic acid from 2019-nCoV, not for any other
viruses or pathogens. The test is only authorized for the duration
of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostic tests for
detection and/or diagnosis of 2019-nCoV under Section 564(b)(1) of
the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner.
CDC guidance on the clinical and epidemiological criteria for
COVID-19 infection risk is available here:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.
More information about LabCorp’s response to COVID-19 is
available at
https://www.labcorp.com/information-labcorp-about-coronavirus-disease-2019-covid-19.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global
life sciences company that is deeply integrated in guiding patient
care, providing comprehensive clinical laboratory and end-to-end
drug development services. With a mission to improve health and
improve lives, LabCorp delivers world-class diagnostic solutions,
brings innovative medicines to patients faster, and uses technology
to improve the delivery of care. LabCorp reported revenue of more
than $11 billion in 2019. To learn more about LabCorp, visit
www.LabCorp.com, and to learn more about Covance Drug Development,
visit www.Covance.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including but not limited to statements with respect to clinical
laboratory testing. Each of the forward-looking statements is
subject to change based on various important factors, many of which
are beyond the Company’s control, including without limitation,
competitive actions and other unforeseen changes and general
uncertainties in the marketplace, changes in government
regulations, including healthcare reform, customer purchasing
decisions, including changes in payer regulations or policies,
other adverse actions of governmental and third-party payers, the
Company’s satisfaction of regulatory and other requirements,
patient safety issues, changes in testing guidelines or
recommendations, adverse results in material litigation matters,
failure to maintain or develop customer relationships, our ability
to develop or acquire new products and adapt to technological
changes, failure in information technology, systems or data
security, and employee relations. 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 our
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.
###
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version on businesswire.com: https://www.businesswire.com/news/home/20200305005823/en/
Media: Pattie Kushner — 336-436-8263 Media@LabCorp.com
Investors: Clarissa Willett —
336-436-5076 Investor@LabCorp.com
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