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Coronavirus Testing Specimen Collection Devices From DNA Genotek, Clinical Enterprises Get FDA EUAs

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for specimen collections devices for SARS-CoV-2 testing developed by DNA Genotek and Clinical Enterprises.

DNA Genotek's OMNIgene·ORAL OM-505 and OME-505 saliva collection devices consist of a long tube with an attached funnel. The funnel lid contains a small sealed reservoir of stabilizing liquid. The devices differ only in model number and labeling, according to the FDA.

The EUA is the first that allows for the unsupervised use of the device at home or in a healthcare setting when used as part of an FDA-cleared or validated at-home test kit, according to OraSure Technologies, the parent company of Ottawa-based DNA Genotek.

The collection kit is included with authorized SARS-CoV-2 tests from Clinical Reference Laboratory and P23 Labs.

OraSure said that DNA Genotek has scaled up manufacturing of the saliva collection devices and plans to expand capacity in the first quarter of next year.

The FDA also granted an EUA for Clinical Enterprise's EmpowerDX At-Home COVID-19 PCR Test Kit, a nasal swab specimen self-collection kit for SARS-CoV-2 testing.

The kit comprises a nasal swab, a collection tube, specimen collection instructions, and materials for shipping the sample to a laboratory for testing, according to the FDA. It is used with a PCR-based SARS-CoV-2 test developed by Eurofins Scientific subsidiary Viracor.

Luxembourg-based Eurofins said that the test, which received FDA EUA, is available online through its direct-to-consumer subsidiary EmpowerDX for $89, with results provided within 24 hours after a sample is received.

Eurofins said that the test is not available in New York, New Jersey, Rhode Island, or Maryland.

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