LabCorp’s Innovative High-Speed COVID-19 Test Gets Emergency Use Authorization from the FDA

With the need for COVID-19 testing growing amid the second wave of the pandemic, LabCorp (NYSE: LH) has received an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its high-speed COVID-19 test. The test uses innovative technology that the company says will improve efficiency and accelerate the speed at which RT-PCR tests detect the virus.

LabCorp – a leading global life sciences company based in Burlington, North Carolina that focuses on advancing health and guiding patient care decisions – announced that it is the first commercial laboratory to receive an EUA from the FDA for the new, innovative, high-speed test.

While the new test is based on RT-PCR molecular detection, it utilizes a high-throughput technique involving a new heat-based extraction method and enhanced technology to extract RNA from samples for COVID-19 testing.

LabCorp was given the green light for the test by the FDA last week, which is set to be rolled out soon.

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“Innovation and scientific advancements will ultimately resolve this public health crisis,” said chief scientific officer of LabCorp, Marcia Eisenberg, PhD, in a statement from the company last week. “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.”

RT-PCR-based testing is currently the gold standard for detecting the novel SARS-CoV-2 coronavirus that causes COVID-19 infection. The new high-throughput method allows for more rapid RNA extraction, accelerating the speed at which test results can be obtained.

The innovative heat extraction process, which has sensitivity comparable to current extraction methods, captures viral particles directly, thereby eliminating the need for RNA extraction reagents to extract and concentrate viral RNA. The novel method significantly increases testing efficiency while decreasing the need for testing reagents and supplies. This will help reduce both the materials and time required to complete molecular COVID-19 tests.

Currently, LabCorp’s average delivery time for results from its COVID-19 molecular tests is 24 hours.

The new test method adds to LabCorp’s other recent molecular testing innovations, including a short nasal swab for at-home sample collection, which is easier to use and more comfortable than traditional swabs.

In July, the company became the first commercial laboratory to receive an FDA EUA for a matrixed pooled sample collection method using its Pixel by LabCorp and LabCorp At Home COVID-19 test collection kits that can be used outside a healthcare setting

Sample pooling allows for increased testing capacity by grouping several samples together, quickly providing test results for individuals within the group. If the test comes back positive, individuals are traditionally re-tested, but LabCorp’s testing method does not necessitate additional testing in most cases. Pooled testing may be used for low risk populations, when testing demand exceeds laboratory capacity, or when testing reagents are in short supply.

The matrixed pooling authorization for at-home collection was an extension of the FDA EUA issued on July 24, which required sample collection by healthcare professionals.

In the company’s statement last week, LabCorp outlined that, “the latest authorizations represent a continuation of LabCorp’s commitment to helping physicians, health systems and patients manage the pandemic, building on a long line of testing firsts for a commercial lab, such as: first FDA EUAs for RT-PCR testing, at-home collection and asymptomatic testing and matrixed pool testing, as well as first online consumer-initiated antibody testing, digital service for physician-initiated patient collection and combined test for multiple respiratory infections including COVID-19 and flu.”

LabCorp has conducted over 15 million molecular tests since its COVID-19 test was first made available in March. The company now has the capability to process 200,000 tests a day with plans to further increase capacity.