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LabCorp Receives FDA Green Light For A New Type Of COVID-19 Test Using Fewer Reagents

LabCorp has received a new emergency authorization from the FDA for a COVID-19 test that does not require the use of chemical reagents to free the coronavirus’s RNA from a sample.

By using a heat-based process that traps and concentrates viral particles in order to coax out their genetic material for sequencing, the company can avoid relying on the extraction reagents required to perform most RT-PCR tests—products that have fallen into short supply over the course of the pandemic.

LabCorp said the high-throughput method will improve its efficiency and streamline the use of its resources while reducing testing delays linked to bottlenecks within the reagent supply chain. The company has previously received amendments to its test’s authorization to allow for the use of different extraction methods in the face of shortages.

“Innovation and scientific advancements will ultimately resolve this public health crisis,” said Marcia Eisenberg, 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 also received an emergency authorization to pool samples collected within people’s homes, or anywhere outside of a healthcare setting. This further expands its ability to test combined samples, with the aim of screening larger groups of people at a low risk of contracting COVID-19 while also conserving testing reagents.

Currently, the company said its testing capacity tops 200,000 tests per day, with 15 million molecular tests performed since March.

Source: https://www.fiercebiotech.com/medtech/labcorp-receives-fda-green-light-for-a-new-type-covid-19-test-using-fewer-reagents

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