Tests Assist in Confirming the Presence of Antibodies to the Virus that Causes COVID-19
BURLINGTON, N.C.–(BUSINESS WIRE)–LabCorp (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding patient care, today announced it will expand serological testing for SARS-CoV-2, the virus that causes COVID-19, to more hospitals and healthcare organizations. The COVID-19 serological tests are in addition to the company’s existing molecular test for COVID-19 that is available nationwide through healthcare providers, and to healthcare workers and emergency responders through its Pixel by LabCorp™ at-home self-collection test kit.
Serological tests for SARS-CoV-2 are intended for individuals who may have had COVID-19 symptoms but are no longer symptomatic. The tests determine the presence of antibodies to the virus and can help to identify individuals who have been exposed to the virus. Understanding if an individual has developed antibodies and a potential immune response can be useful in the determination of important decisions such as the ability for hospital staff to care for patients.
“LabCorp’s scientists are continuously focused on making novel testing options available to address COVID-19,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “While results from serological tests are neither the sole basis for a diagnosis nor assurance of immunity, we believe the tests will play a critical role in helping healthcare providers determine appropriate treatment for individuals suspected of having been infected with the virus.”
LabCorp began offering serological tests to hospitals and healthcare systems on a limited basis in late March, focusing on high priority healthcare workers. The company has built up capacity to perform over 50,000 serological tests per day and complete those tests within an average of 1 to 3 days from the time the specimen is picked up, assuming adequate supplies. The company is preparing to make the tests more broadly available over the coming weeks for ordering by hospitals and health systems, organizations, and physicians. By mid-May, LabCorp expects to be able to perform several hundred thousand tests per week as more tests and testing platforms receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
Serological tests analyze serum in blood samples from individuals who are being evaluated or have been exposed to the virus. The company offers separate tests for each of the three major classes of SARS-CoV-2 antibodies (IgG, IgA, and IgM).
Beginning Monday, April 27, physicians will be able to direct asymptomatic patients to LabCorp’s approximately 2,000 patient service centers for specimen collection for SARS-CoV-2 IgG testing. In addition, collection for all three SARS-CoV-2 antibody tests will be available to be performed by LabCorp’s nearly 6,000 phlebotomists located in physician offices and healthcare facilities nationwide.
The company will also work with hospitals where it provides laboratory management and technical support services to help them establish serological testing in their on-site laboratories. Updates related to LabCorp’s COVID-19 response are available on LabCorp’s COVID-19 microsite.
A positive serologic result indicates that an individual has likely produced an immune response to the SARS-CoV-2 virus. A negative serologic result indicates that an individual has not developed detectable antibodies at the time of testing. While contingent on a variety of factors, this could be due to testing too early in the course of COVID-19, the absence of exposure to the virus, or the lack of an adequate immune response, which can be due to conditions or treatments that suppress immune function.
Confirmation of infection with SARS-CoV-2 must be made through a combination of clinical evaluation and other applicable tests. Decisions about ongoing monitoring, treatment or return to normal activities for patients being treated for suspected infection with SARS-CoV-2 should also be made in accordance with guidance from public health authorities.
These tests have not been reviewed by the FDA, but are being offered by LabCorp in accordance with the public health emergency guidance issued by the FDA on March 16.
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 diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to statements with respect to clinical laboratory testing, the potential benefits of COVID-19 serological testing, our responses to and the expected future impacts of the COVID-19 pandemic, and the opportunities for future growth. 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, whether our response to the COVID-19 pandemic will prove effective, the impact of the COVID-19 pandemic on our business and financial condition, as well as on general economic, business, and market conditions, 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, federal, state, and local governmental responses to the COVID-19 pandemic, 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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