BURLINGTON — Burlington-based LabCorp, a leader in COVID-19 testing, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration to deploy an improved laboratory test for detecting the coronavirus infection.
The test uses heat and technology instead of chemical reagents to extract RNA from samples collected for COVID-19 molecular testing. The advancement will improve the speed and efficiency of reverse transcription polymerase chain reaction (RT-PCR) tests, considered the gold standard for detecting active infections, the company said in a news release.
“Innovation and scientific advancements will ultimately resolve this public health crisis,” said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. “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 is the first company to receive an EUA for the improved test, which has not been FDA cleared or approved for permanent use. The FDA can issue EUAs during health emergencies when there are no adequate, approved and available alternatives for diagnosing, treating or preventing a serious or life-threatening disease.
No reagents needed
LabCorp’s heat-extraction process, which has comparable sensitivity to current extraction methods, traps viral particles, eliminating the need for RNA extraction reagents to capture and concentrate nucleic acid found in SARS-CoV-2, the novel coronavirus that causes COVID-19 infection.
This substantially improves testing efficiency and decreases LabCorp’s reliance on testing supplies, streamlining resources and reduces the time needed to complete and report results for molecular tests.
LabCorp said its current average result delivery time for COVID-19 molecular tests is 24 hours.
The new method adds to other LabCorp molecular testing innovations, such as its short nasal swab for at-home collection, which is easier to use and more comfortable for patients.
LabCorp said it has performed over 15 million molecular tests since first making the COVID-19 test available in March and is now able to process 200,000 tests per day with plans to increase capacity.
Matrix pooling also gets EUA
LabCorp also announced that it is the first commercial laboratory to receive an EUA for the use of matrixed pooling on samples collected outside a healthcare setting, via its Pixel by LabCorp and LabCorp At Home COVID-19 test collection kits.
The matrixed pooling authorization for at-home collection is an extension of the FDA EUA issued July 24. It allows LabCorp to test larger groups of samples at one time on specimens collected by a healthcare professional.
Pooling allows for increased testing capacity and can quickly provide quality test results for individuals within the group, without requiring retesting in most cases. Pooled testing may be used for populations at low risk of COVID-19, when testing demand exceeds laboratory capacity, or when testing reagents are in short supply.
The latest authorizations for LabCorp follow a long line of testing firsts for a commercial lab, such as: first EUA for RT-PCR testing, first EUA for at-home collection, first online consumer-initiated antibody testing, first digital service for physician-initiated patient collection, first EUA for asymptomatic testing and matrixed pool testing, and first combined test for multiple respiratory infections including COVID-19 and flu.
LabCorp is a global life sciences company that provides clinical laboratory and drug development services. It reported revenue of more than $11.5 billion in 2019.
LabCorp, an S&P 500 company, employs about 7,300 people across North Carolina including about 3,600 people in Alamance County, where it is the largest private employer. The company employs nearly 61,000 people worldwide.
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