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Thermo Fisher Scientific, Ellume Get FDA Emergency Use Authorizations for SARS-CoV-2 Tests

The story previously incorrectly stated Ellume's test is a serology test. Also, the HHS contract was to scale up production of a test, not to develop it. 

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for an RT-PCR-based SARS-CoV-2 test developed by Thermo Fisher Scientific and a point-of-care antigen test for the virus from Ellume.

Thermo Fisher's TaqPath COVID-19 RNase P Combo Kit 2.0 is designed to detect SARS-CoV-2 nucleic acid in healthcare provider-collected nasopharyngeal swabs and anterior or mid-turbinate nasal swabs from individuals suspected of having COVID-19. It is also authorized for use in asymptomatic individuals when tested twice over two or three days with at least 24 hours, and no more than 36 hours, between tests.

The test may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.

In June, Waltham, Massachusetts-based Thermo Fisher received FDA EUA for its TaqPath COVID-19 Pooling Kit, which tests for SARS-CoV-2 in up to five individual samples at once.

The Ellume Lab COVID Antigen Test is designed for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct mid-turbinate nasal swab specimens collected by healthcare providers.

The fluorescent lateral flow immunoassay may be used by any lab CLIA-certified to perform moderate-complexity, high-complexity, or waived tests, according to the FDA. It may also be used in point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

In February, Australia-based Ellume received a $231.8 million contract from the US Department of Health to increase production of an over-the-counter, at-home SARS-CoV-2 test.