Skip to main content
Premium Trial:

Request an Annual Quote

Amazon, Diabetomics Get FDA Emergency Use Authorizations for Coronavirus Tests

NEW YORK ─ The US Food and Drug Administration has granted separate Emergency Use Authorizations for SARS-CoV-2 assays developed by Amazon and Diabetomics.

The agency granted EUA to STS Lab Holdco, a subsidiary of, for the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2. The test is authorized as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home using the Amazon COVID19 Test Collection Kit DTC. Any individual 18 years or older, including individuals without symptoms or other reasons to suspect COVID-19, can conduct testing.

The test is also authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples containing up to five individual anterior nasal swab specimens per pool that are collected in individual vials containing transport medium by any individual 18 years of age or older, including individuals without symptoms or other reasons to suspect COVID-19.

In March, Amazon had received EUA for its Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2. The test detects the ORF1ab gene of the virus in anterior nasal swab specimens self-collected using either the Amazon COVID-19 Collection Kit under the supervision of a healthcare provider or the Amazon COVID-19 Test Collection Kit unsupervised at home.

Meanwhile, Hillsboro, Oregon-based Diabetomics nabbed an EUA for its CovAb SARS-CoV-2 Ab Test, which detects total antibodies, including IgG, IgA and IgM, to SARS-CoV-2 in human oral fluid. The test identifies individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, according to the FDA website. Samples should only be tested from individuals that are 15 days or more post-symptom onset, and emergency use of the test is limited to authorized laboratories.

The Scan

Fertility Fraud Found

Consumer genetic testing has uncovered cases of fertility fraud that are leading to lawsuits, according to USA Today.

Ties Between Vigorous Exercise, ALS in Genetically At-Risk People

Regular strenuous exercise could contribute to motor neuron disease development among those already at genetic risk, Sky News reports.

Test Warning

The Guardian writes that the US regulators have warned against using a rapid COVID-19 test that is a key part of mass testing in the UK.

Science Papers Examine Feedback Mechanism Affecting Xist, Continuous Health Monitoring for Precision Medicine

In Science this week: analysis of cis confinement of the X-inactive specific transcript, and more.