Applied DNA to launch Omicron specific PCR test kit

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DTMT Network

New York based Applied DNA Sciences, Inc. today announced its COVID19 diagnostic strategy in response to the emergence of the Omicron variant.

The company plans to introduce its ‘Linea 2.0’ COVID-19 Assay, a new RT-PCR assay for the SARS-CoV-2 E and N genes that build on the Company’s established COVID19 line of diagnostics, after submission of its validation data to the New York State Department of Health in the course of next few days, the announcement said.

The Company also announced that its emergency utilisation authorised Linea COVID19 Assay Kit (the “Linea 1.0 Assay”) likely exhibits a unique double S-gene target failure (or “drop”) (SGTF) specific to the Omicron variant.

Analysis of the mutations that are seen in the Omicron variant’s genome sequences using in silico technique shows that neither of the Linea 2.0 assay targets is affected by the variant’s mutations, it added.

According to the announcement, validation testing for the Linea 2.0 assay has already been completed for both single sample and pooled testing, and the company plans to submit its validation data as a laboratory developed test to the New York State Department of Health in the next few days.

The announcement further stated that the validation data for the Linea 2.0 Assay revealed that it meets or exceeds the performance of the Linea 1.0 Assay.

“Viruses evolve; it is in their nature. The potential need to evolve the Linea Assay 1.0 assay was anticipated and spurred the side-by-side development of our Linea SARS-CoV-2 Mutation Panel and the Linea 2.0 Assay to utilise the same testing workflows established for the Linea 1.0 Assay that brought high specificity, high sensitivity, and rapid time to results for population-scale testing, Dr James A. Hayward, president and CEO of Applied DNA, said.

The Linea COVID19 assay kit is a real-time RT-PCR test intended for the detection of nucleic acid from SARS-CoV-2 in respiratory specimens collected by a healthcare worker from individuals who are suspected of COVID19.


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