Care Access Research to Lead Clinical Trial of Breakthrough Coronavirus Test

07 April 2020

GMP News

Care Access Research, the leader in rapid development and management of high-performing clinical research sites, announced it is leading a validation trial in conjunction with the FDA for a new at-home COVID-19 test developed by a private genomics lab that manufactures DNA screening kits.

The goal of this validation study is to evaluate the efficacy of the new at-home test for diagnosing COVID-19. Mailing simple testing kits directly to patients could help reduce visits to overwhelmed clinics and hospitals, ease traffic at drive-through testing sites and enhance social distancing efforts.

Care Access Research will lead the validation study at several of its clinical research sites across the US. Expected to be completed within weeks, the clinical trial will need between 60 and 500 patient volunteers to determine the test’s accuracy at diagnosing the COVID-19 disease caused by the pandemic novel coronavirus (SARS-CoV-2) sweeping the globe.

If approved by the FDA, the new COVID-19 test will offer similar conveniences to the private lab’s currently available at-home genetic test kits that screen DNA for a variety of medical conditions.

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