Next-Generation Sequencing Applications for Antiviral Drug Development & FDA Guidance for Data Submission

Life Sciences, Clinical Trials, Pharmaceutical, Drug Discovery & Development,
  • Friday, November 11, 2022

Accurate detection and monitoring of minority variants that confer drug and antiviral resistance is critical to therapeutic and vaccine trials. Specifically, it aids in controlling the emergence of novel variants that can potentially lead to outbreaks of disease and breakthrough infections. Gene variants can compromise virologic response and impact clinical outcomes.

In this webinar the featured speaker explores the following case study:

Viracor Biopharma Services has developed and validated a next-generation sequencing (NGS) assay to determine the genetic variability in the F gene of respiratory syncytial virus (RSV) isolated from human nasal swab (NS) specimens. The NGS method has several advantages over standard Sanger sequencing related to higher sensitivity, quantifiable, cost effective and automatable data analysis steps. The study utilized a deep sequencing approach to quantify minority variants. The patients in this study received a therapeutic targeting RSV. Defined proportions of artificial virus quasispecies were used in creation of artificial RNA pools, and their relative proportions were measured using the NGS assay. The assay was validated for the performance characteristics such as analytical sensitivity, precision and accuracy.


The results showed that minority variants present at three percent of quasispecies were detected reproducibly with minimal variation between technical replicates, and the observed amino acid frequencies were comparable to expected frequencies. The generated data was used to support the resistance assessments for the development of antiviral therapeutic and clinical outcomes.

For calling mutations that are at frequencies below five percent, Viracor recommends a unique molecular identifier (UMI)-based ultrasensitive sequencing approach. Based on literature, the non-UMI based mutant detection was not reproducible for clinical samples with low template yield.

The sequencing method and data analysis pipeline were developed in accordance with the US Food and Drug Administration (FDA)’s guidance on submitting NGS data to the Division of Antiviral products. The generated data was submitted to FDA — which includes submitting a detailed protocol that describes sample processing, data analysis methods and result reporting — and then it was independently analyzed by the Division to ensure whether the emergence of resistance is carefully explained and characterized in the label of newly approved antiviral drug products. This resistance or variant information helps healthcare professionals who oversee the use of antiviral therapeutics, and the information is part of the drug product information approved by the Division.

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To learn more about the applications of this NGS assay and get FDA guidance on data submission, register for this webinar on antiviral drug development.


Kirthi Kutumbaka, Viracor Biopharma Services

Kirthi Kutumbaka, PhD, Senior Research Scientist, Eurofins Viracor BioPharma

Dr. Kirthi Kutumbaka joined Eurofins Viracor Biopharma services in 2021 as a Senior Scientist in Kansas City, Kansas. In his current role, he serves as the technical lead for developing and validating assays to detect and quantify viruses utilizing next-generation sequencing (NGS) and Sanger sequencing. He has nine years of experience in the life sciences industry. He earned his PhD in microbiology, and master’s in bioinformatics from Northern Illinois University in Dekalb, IL. Later as a Post-Doc Researcher and Research Scientist at IEH laboratories and Consulting Group, he participated in numerous foodborne outbreak investigations. At IEH labs he utilized NGS for the identification of variants of concern and performed comparison studies. Over the years, he has built his expertise in molecular microbiology focusing on utilizing sequencing-based assays for infectious disease research.

Message Presenter

Who Should Attend?

  • Scientists and other technical professionals working in the development of antiviral therapeutics
  • Program/project leads with pharmaceutical and biotech companies developing therapies or vaccines for infectious disease

What You Will Learn

Attendees will gain insights into:

  • The importance of detection and control of novel variants in antiviral therapy and vaccine development trials
  • Learnings and recommendations from Eurofins-Viracor’s experience supporting antiviral therapy studies with next-generation sequencing (NGS) testing and analysis
  • Review of NGS procedures and data submissions in support of resistance assessments for antiviral drug development
  • The US Food and Drug Administration (FDA)’s guidance for NGS data submissions to the Division of Antiviral Products.

Xtalks Partner

Eurofins Viracor Biopharma

Truly innovative therapeutics are built on advanced science, disruptive technology, and reliable partnerships. From vaccines to cell and gene therapies, Eurofins Viracor BioPharma is a unique development partner with proven expertise across a broad array of industry-leading analytical technologies, providing integrated testing solutions to help advance your pioneering treatments to patients faster.

We are a team of highly experienced scientists and professionals, providing complex testing and assay development for clinical research. We offer broad experience in molecular infectious disease and immunogenicity testing, along with immune response monitoring, vaccine safety/efficacy assessment, and disease-associated biomarker testing.

Everyday our team works collaboratively with our sponsor partners to solve some of the toughest bioassay challenges, leveraging the unique combination of state-of-the-art technology, and specialized expertise, that drug development companies have come to rely on for their clinical study needs

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