Pathnostics Launches COVID-19 PCR Laboratory Test Designed to Detect Acute Infection

Pathnostics has launched a COVID-19 polymerase chain reaction (PCR) laboratory test designed to support U.S. health care workers. Pathnostics created the test after hearing from its customers who specialize in emergency, mobile and post-acute health care that they needed access to a test that is easy to administer and adept at identifying people infected with COVID-19.

As a CLIA high-complexity laboratory, Pathnostics will perform its new PCR test as a Laboratory Developed Test (LDT) based on Thermo Fisher Scientific Inc.'s TaqPath™ RT-PCR COVID-19 Kit, which received Emergency Use Authorization (EUA) on March 13, 2020 from the U.S. Food and Drug Administration.

Pathnostics' new PCR test is administered using a nasal swab that can detect the genetic information of the virus within 24 to 48 hours:

• Once the sample is collected, it is packaged in Pathnostics' proprietary buffer that inactivates the virus to ensure the safety of health care and other essential workers during transit of the sample to Pathnostics' laboratory.

• The sensitive molecular test targets the identification of three regions of the SARS-CoV 2 RNA.

• The American Health Care Association (AHCA) and National Center for Assisted Living (NCAL) are currently recommending providers utilize PCR tests based on their ability to diagnose active COVID-19 infections with a high degree of accuracy.

• The test is billed directly to insurance and does not require an out-of-pocket patient expense.

"Pathnostics is committed to helping to build testing capacity during the COVID crisis, particularly to support providers and other workers in the health care industry as they continue their essential work. Along with our COVID-19 PCR test, we will be launching a respiratory panel assay in the near future with the goal of identifying additional pathogens which might be impacting COVID patients, particularly those in long-term care situations," said Dr. David Baunoch, founder and chief scientific officer, Pathnostics.