Amazon, Cleveland Clinic Get FDA Emergency Use Authorizations for SARS-CoV-2 Tests

Original from Genomeweb

The US Food and Drug Administration this week granted separate Emergency Use Authorizations for two PCR-based SARS-CoV-2 tests from Amazon subsidiary STS Lab Holdco and one from the Cleveland Clinic.

The Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test is designed to detect SARS-CoV-2 nucleic acid in anterior nasal swab specimens self-collected on-site at Amazon facilities using the Amazon COVID-19 Collection Kit or Amazon On-Site COVID-19 Test Collection Kit. Samples may also be self-collected at home using the Amazon COVID-19 Test Collection Kit. The test may also be used with pooled samples containing up to five individual self-collected anterior nasal swab specimens.

The direct-to-consumer Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test is designed to detect SARS-CoV-2 nucleic acid in individual anterior nasal swab specimens self-collected at home using the Amazon COVID-19 Test Collection Kit DTC or in pooled samples containing up to five individual anterior nasal swab specimens.

Both Amazon tests may only be performed by STS Labs Holdco-designed labs that are CLIA-certified to perform high-complexity tests.

Earlier this year, STS Labs Holdco received EUA from the FDA for the direct-to-consumer Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 and the Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2.

The Cleveland Clinic's SelfCheck COVID-19 TaqPath Multiplex PCR is designed to detect SARS-CoV-2 nucleic acid in anterior nasal swab specimens self-collected at home using the SelfCheck COVID-19 Swabbing Kit.

The test may only be performed at the Cleveland Clinic, according to the FDA.

The test runs a specific workflow of Thermo Fisher Scientific's TaqPath COVID-19 Combo Kit, which received EUA in March 2020. Thermo Fisher has granted Cleveland Clinic right of reference to data to support the use of the SelfCheck COVID-19 Swabbing Kit with TaqPath COVID-19 Combo Kit, according to the FDA.

Source: Amazon, Cleveland Clinic Get FDA Emergency Use Authorizations for SARS-CoV-2 Tests | Genomeweb