Linea Covid-19 Assay Kit was authorised by FDA EUA to detect nucleic acid from SARS-CoV-2 in respiratory specimens
Applied DNA Sciences announced that the US Food and Drug Administration (FDA) has identified its Linea Covid-19 Assay Kit as one of the only two (FDA EUA-granted) tests capable of detecting new strain of SARS-CoV-2, found in the UK (B.1.1.7).
The molecular technologies firm said that the B.1.1.7 variant has been identified within the US and according to recent publications, the new variant may be associated with an increased risk of transmission of the virus that causes Covid-19.
The Linea Covid-19 Assay Kit was authorised by FDA EUA to detect nucleic acid from SARS-CoV-2 in respiratory specimens, drawn from the individuals who are suspected of Covid-19, in a healthcare setting.
Applied DNA president and CEO James A 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.”
Applied DNA said that identifying certain mutations can help determine samples that need to be further characterised through genetic sequencing, and facilitates the early detection of new variants to reduce the further spread of infection.
The US FDA, in its communication said that it will monitor the effects of genetic variation on molecular tests authorised for emergency use, including the Applied DNA’s assay kit.
Also, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to the effects of genetic variation compared to single genetic target tests.
In the analysis conducted by the company and FDA, one of the two S-gene targets of the assay kit has significantly reduced sensitivity in the presence of certain S-gene mutations.
The reduced sensitivity is also known as S-gene dropout, and it indicates certain SARS-CoV-2 mutations, including the new mutated strain found in the UK.
Hayward added: “Using our Assay Kit, we have already identified variants of SARS-CoV-2 via S-gene dropout, sequenced the identified variants with partners and identified common genetic progenitors that are shared by B.1.1.7 and other emerging SARS-CoV-2 variants.
“Utilizing this knowledge, we have begun to develop new assays to detect specific mutations in SARS-CoV-2 and to adapt our assay to address the evolving SARS-CoV-2 threat.”
The FDA has amended the Emergency Use Authorization (EUA) for the test, expanding the installed base of RT-PCR platforms that can process the Linea Covid-19 Assay Kit.