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LabCorp seeks FDA approval for at-home COVID-19, flu, RSV combined test


Elizabeth Pattman   | Times-News

Last week, LabCorp announced the launch of it combined COVID-19, influenza A and B and respiratory syncytial virus (RSV) test. The Burlington-based corporation is still pushing for FDA approval to offer the combined test through at-home collection kits.

With flu season quickly approaching, LabCorp representatives said annual illnesses could put added strain on healthcare systems. Between Oct. 1, 2019, and April 4, 2020, the CDC estimated between 39 and 56 million cases of the flu resulting in 18 to 26 million medical visits, a press release said.

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“The U.S. is facing the most challenging health crisis in a century and is about to enter flu season, which has the potential to put additional strain on our healthcare system and cost lives,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “Individuals infected with COVID-19, influenza A / B, or RSV, often experience similar symptoms of cough, fever, chest tightness, and body aches, providing a potential surge of patients seeking testing. Leveraging our scientific and technological expertise to simultaneously test for four major respiratory viruses, including COVID-19, will provide doctors a simple, efficient way to diagnose their patients.”

A press release from the company said the combined test is part of their continued mission to meet the demand for COVID-19 diagnostic testing, especially as the pandemic and flu season overlap. The test is currently available through doctors, hospitals and other authorized healthcare providers, but LabCorp is seeking to add it to its Pixel by LabCorp at-home test collection kits.

More: LabCorp works to increase, prioritize COVID-19 testing

“Pending authorization by the FDA, the Pixel by LabCorp at-home test will be another convenient option for individuals to determine if they have the flu, COVID-19, or RSV,” the release said.

LabCorp reported thousands of people have used the at-home collection kits thus far and over 13 million tests have been completed since March using various sample collection methods, including the at-home collections.