Applied DNA Sciences, Inc. has submitted its request for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its Linea SARS-CoV-2 Mutation Panel.
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The Mutation Panel is designed for the qualitative detection of the E484K, E484Q, L452R, and N501Y SARS-CoV-2 genetic mutations in samples that have tested positive for COVID-19 on the Company’s EUA authorized Linea COVID-19 Assay Kit.
The E484K, L452R, and N501Y mutations have been identified by the Centers for Disease Control and Prevention as potentially having a negative impact on the efficacy of certain anti-SARS-CoV-2 monoclonal antibody treatments (“mAbâ€) and have been identified by the CDC as substitutions of therapeutic concern.
The Mutation Panel is comprised of four separate Single Nucleotide Polymorph (“SNPâ€) genotyping assays that utilize allelic discrimination plot analysis to identify whether a sample contains the wildtype or mutant sequence for the targeted mutation.
The Mutation Panel is configured to be used with high-throughput robotic extraction platforms and RT-PCR analysis on the QuantStudio Dx RT-PCR instrument. During validation studies, the Mutation Panel showed 100% concordance with the results obtained from Next Generation Sequencing (NGS).
Dr. James A. Hayward, president and CEO of Applied DNA, stated, “Distribution of a previously EUA-authorized, single-agent mAb treatment was halted due to SARS-CoV-2 mutations that are detected by our Mutation Panel. In addition, a currently EUA-authorized mAb treatment is known to be negatively impacted by mutations detected by our Mutation Panel.
"As such, we believe that if the Mutation Panel becomes EUA-authorized, testing for the genetic mutations targeted in our Mutation Panel may be warranted prior to the administration of mAb treatments known to be impacted by some of the mutations detected by our Panel, especially in geographic areas where the mutations are known to be circulating.
“In addition, we believe we have developed an efficient workflow for the discovery and validation of SNP genotyping assays for the detection of SARS-CoV-2 mutations. Should new mutations gain prevalence, such as those in the AY4.2 variant, we believe we are well positioned to rapidly offer additional SNP genotyping assays for the detection of new mutations,†concluded Dr. Hayward.
While the rise of Delta has potentially reduced the genomic heterogeneity of SARS-CoV-2 in the United States, genetic variations that can give rise to additional new mutations and variants continue to be of concern.
The recent rise of the AY4.2 (“Delta plusâ€) variant in the United Kingdom, with new mutations in the Spike protein, highlight the continued risk of SARS-CoV-2 mutations.
The emergence of new mutations or the re-emergence of known mutations underlies the importance of our efforts to develop and provide tools that can rapidly identify mutations of concern to assist healthcare providers in determining appropriate treatments for COVID-19 patients. ■