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Amazon gets FDA authorization for an at-home COVID-19 test kit

Amazon gets FDA authorization for an at-home COVID-19 test kit
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Amazon gets FDA authorization for an at-home COVID-19 test kit

Amazon gets FDA authorization for an at-home COVID-19 test kit

Amazon acquired Meals and Drug Administration authorization for a COVID-19 test made by its subsidiary STS Lab Holdco, and it plans to make use of it for its onsite coronavirus testing applications.

The test is finished utilizing a nasal self swab that may be carried out both beneath the supervision of a well being care supplier or as a part of an at-home kit the place a affected person takes their very own pattern and mails it to a centralized lab.

“Amazon plans to make use of the Amazon Actual-Time RT-PCR Test for Detecting SARS-CoV-2 (Amazon Test) as a part of the corporate’s total Coronavirus Illness 2019 (“COVID-19”) preparedness and response program,” the FDA’s authorization reads.

The authorization additionally describes Amazon’s employee-screening program. Some Amazon staff might be robotically given testing appointments round each 14 days. The exams are voluntary. “Amazon has partnered with a third-party healthcare supplier who will problem the required prescriptions and particular person test orders,” the authorization mentioned.

The authorization letter is addressed to Cem Sibay, the vp of Amazon Labs. Final summer season, Amazon tapped Sibay to construct its in-house COVID-19 testing lab, Enterprise Insider reported. In October, the corporate mentioned it had the infrastructure to run tens of hundreds of exams for staff every day.

The brand new test is a modification of one other COVID-19 test made by BGI Genomics, which the authorization mentioned Amazon used on the finish of August. The corporate started utilizing the modified model that may change into the Amazon test on August twenty eighth, 2020. Between late September and early December 2020, it ran over 560,000 samples, in line with the authorization.

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Amazon began promoting at-home COVID-19 testing kits made by genomics firm DxTerity in January. That test sells for $110. The corporate continues to broaden into well being care: final week, it introduced that it could begin providing its in-house telehealth and at-home well being care program to different firms. Amazon has additionally expressed curiosity in medical testing earlier than. In 2018, the corporate was in talks to purchase diagnostics firm Confer Well being.

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