Amazon receives FDA approval for a COVID-19 home testing kit


Amazon was awarded the Food and Drug Administration authorization for a COVID-19 test made by subsidiary STS Lab Holdco, and plans to use it for its onsite coronavirus testing programs.

The test is done using a nasal self-swab that can be done under the supervision of a healthcare provider or as part of a home kit where a patient takes their own sample and sends it to a centralized laboratory.

Amazon plans to use Amazon Real-Time RT-PCR test to detect SARS-CoV-2 (Amazon test) as part of Overall Coronavirus Disease 2019 (“COVID-19”) Preparedness Program and response. authorization reads

The authorization also describes Amazon’s employee screening program. Some Amazon employees automatically get a test appointment every 14 days. The tests are voluntary. “Amazon is working with a third-party healthcare provider who will issue the necessary prescriptions and individual test orders,” the authorization said.

The letter of authorization is addressed to Cem Sibay, Amazon Labs vice president. Last summer, Amazon hired Sibay to build its own COVID-19 testing lab, Business insider reportedIn October, the company said it had the infrastructure to run tens of thousands of employee tests every day.

The new test is a modification of another COVID-19 test made by BGI Genomics, die the authorization Amazon said in late August. The company started using the modified version that would become the Amazon test on August 28, 2020. Between the end of September and the beginning of December 2020, according to the authorization

Amazon started selling COVID-19 home test kits made by genomics company DxTerity in JanuaryThat test is selling for $ 110. The company continues to expand into healthcare: Last week, it announced that it would offer its in-house tele-health and home-care program to other companies. Amazon has also shown interest in medical testing before. In 2018, the company has was busy to buy diagnostics company Confer Health.