LabCorp (LH) Launches Test To Detect Presence Of Coronavirus
Zacks Investment Research | Mar 08, 2020 09:45PM ET
Laboratory Corporation of America Holdings (NYSE:LH) , or LabCorp announced the availability of LabCorp 2019 Novel Coronavirus (COVID-19), NAA test, effective Mar 5. The test effectively detects the presence of the underlying virus causing the COVID-19 and is to be used for patients that meet the current evaluation guidance of infection with the same.
However, the test can only be ordered by physicians and other authorized healthcare providers anywhere in the United States.
Apart from the test for COVID-19, the company is also eligible to perform the Centers for Disease Control and Prevention (“CDC”) 2019-nCoV Real-Time RT-PCR Diagnostic Panel, if needed, to meet higher testing demand. Although the CDC test has not been approved by the FDA yet, LabCorp has been authorized under an Emergency Use Authorization (EUA) for use by authorized laboratories.
With the recent test launch, the company aims to strengthen its Covance Drug Development (CDD) business globally.
A Peek Into the Tests
The internally developed LabCorp 2019 Novel Coronavirus (COVID-19), NAA test has been made available under the guidance issued by the FDA and has been validated for use with respiratory samples. The test is a qualitative evaluation, using the PCR technology. Notably, LabCorp is one of the key contributors to the commercialization of the technology.
However, the FDA’s independent review of the validation is pending. LabCorp is also pursuing an EUA for the NAA test.
The CDC test is for the presumptive detection of 2019-nCoV RNA in upper and lower respiratory specimens, and other authorized specimens collected from individuals, meeting the CDC criteria for the COVID-19 testing.
Significance of the NAA Test Launch
Per the company, the availability of a high-quality, reliable and scalable laboratory test is crucial, given the current scenario, where COVID-19 continues to spread in the United States. It is of utmost importance to efficiently identify infected people and provide appropriate care to better manage the use of healthcare resources, thus helping contain the spread of the virus.
Apart from the LabCorp 2019 Novel Coronavirus (COVID-19), NAA test, the company has been authorized to carry out the CDC test only for the detection of nucleic acid from 2019-nCoV and not for any other viruses or pathogens. The NAA test is only authorized for the duration of the declaration that conditions exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of 2019-nCoV.
Industry Prospects
LabCorp has two reporting segments, including CDD, which is a global contract research organization (CRO) and a comprehensive drug development service provider.
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