LabCorp Receives EUA from FDA for New High-Speed COVID-19 Test
Global life sciences company LabCorp Diagnostics has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a new type of COVID-19 test, which the company says will improve efficiency and accelerate the speed at which RT-PCR tests detect the virus.
In a statement made by the Burlington, N.C.-based company on October 2, it was announced that the FDA granted LabCorp the ability to roll out its test. The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.
“Innovation and scientific advancements will ultimately resolve this public health crisis,” chief scientific officer of LabCorp, Marcia Eisenberg, Ph.D., said in a statement. “We are constantly evaluating new technologies and methods to improve the testing process, and we are excited to pioneer and introduce RNA-extraction free methodology in our laboratories, and to the diagnostic community at large.”
LabCorp’s test features a heat extraction process that traps viral particles and bypasses any requirement for RNA extraction reagents to obtain and concentrate the viral nucleic acid. According to the company, this reduces reliance on additional testing supplies and further reduces “the time needed to complete and report results for molecular tests.”
LabCorp noted it has performed more than 15 million molecular tests since the company first made the COVID-19 test available in March of this year. Now, the diagnostics company is processing approximately 200,000 tests each day and plans on increasing its capacity even further.
In conjunction with this news, LabCorp also announced that the FDA granted an additional EUA to LabCorp’s use of matrixed pooling of samples collected with Pixel by LabCorp™ and LabCorp At Home COVID-19 test collection kits. The company said this EUA, which is an extension to a previous EUA granted by the FDA on July 24, will also assist the company in testing a larger group of samples at a single time point while reducing overall lab demands.
“Pooling methods test groups of individuals efficiently and with high quality, while increasing our overall testing capacity,” said LabCorp’s chief medical officer and president, Brian Caveney, in a statement. “The demand for testing continues to increase and we are committed to finding innovative solutions to ensure testing is available.”
While LabCorp’s COVID-19 molecular test was given the EUA for the detection of nucleic acid from severe acute respiratory syndrome coronavirus 2, it cannot be used for detection of other viruses or pathogens. The company added that the tests have not been cleared or approved by the FDA for such use.
“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 COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner,” the company’s statement said.
LabCorp has been actively working this year to provide enhanced COVID-19 testing services for several centers across the globe. In early September, for instance, the company launched its first combined single-panel test that simultaneously detects COVID-19, influenza and respiratory syncytial virus. LabCorp submitted an application to the FDA to allow the test to be offered through its Pixel by LabCorp At Home test collection kits, as the test is only currently provided to patients through doctors, hospitals and authorized healthcare providers in the U.S.
In addition, LabCorp recently joined into a multi-year partnership with Infirmary Health, a large non-governmental healthcare system in southern Alabama, to provide diagnostic testing laboratory services to both providers and patients across the eastern Gulf Coast region. The partnership was designed to include strategies that will increase Infirmary’s capacity for COVID-19 testing across the state of Alabama. And in late July, LabCorp also announced a program that will offer total antibody testing for patients for free in an effort to increase the amount of available blood plasma donations that can be used as a possible treatment for COVID-19.