US FDA lists Applied DNA Sciences’ Covid-19 test for virus detection

11 January 2021 (Last Updated January 11th, 2021 10:30)

The US Food and Drug Administration (FDA) has published a safety communication that identifies Applied DNA Sciences’ Linea COVID-19 Assay Kit as one of only two tests marketed under its emergency use authorisation (EUA) to detect certain SARS-CoV-2 mutations.

US FDA lists Applied DNA Sciences’ Covid-19 test for virus detection
The kit is used for the qualitative detection of SARS-CoV-2 nucleic acid. Credit: Mufid Majnun / Unsplash.

The US Food and Drug Administration (FDA) has published a safety communication that identifies Applied DNA Sciences’ Linea COVID-19 Assay Kit as one of only two tests marketed under its emergency use authorisation (EUA) to detect certain SARS-CoV-2 mutations.

The mutations include the one found in the UK variant of SARS-CoV-2 called B.1.1.7. It can potentially increase the transmission risk of the virus that causes Covid-19.

The detection of specific mutations can help in identifying samples that should be further characterised through genetic sequencing and can help to detect the new variants in patients early.

Authorised by FDA EUA, the kit is used for the qualitative detection of SARS-CoV-2 nucleic acid in respiratory samples such as anterior nasal swabs, nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, and nasopharyngeal washes / aspirates or nasal aspirates.

In addition, it can test for the virus in bronchoalveolar lavage (BAL) specimens taken by a healthcare professional from people who are suspected of Covid-19 by a healthcare provider.

Applied DNA Sciences president and CEO Dr James Hayward said: “Our ability to potentially identify certain variants of SARS-CoV-2 is grounded in the multi-target design of our assay that mitigates the impact of a mutation to the S-gene on test sensitivity.

“We believe our assay kit can give public health officials and diagnostic laboratories a fast and cost-efficient tool – whether through diagnostic or pooled surveillance testing – with which to potentially identify and track B.1.1.7 spread that is made all the more challenging by the variant’s apparent transmission advantage.”

Last month, Applied DNA Clinical Laboratories (ADCL), a wholly owned subsidiary of Applied DNA Sciences, entered a reseller and sales referral partnership with US-based health and safety solutions provider CLEARED4.