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Genome Webinar

Chief Scientific Officer, Fry Laboratories

Mitigation of the SARS-CoV-2 pandemic will continue to require innovative solutions. This webinar will outline how Fry Laboratories rapidly redeployed a next-generation sequencing (NGS) pipeline originally created for the detection and identification of bacterial, eukaryotic, and fungal infections in response to SARS-CoV-2.

NGS offers unbiased microbial detection while leveraging the analytical and cost-effectiveness advantages of PCR-based methods. This represents a relatively untapped resource, but the approach creates several unique implementation challenges and solutions. 

In this webinar, Jeremy Ellis of Fry Laboratories will describe an ultra-high-throughput SARS-CoV-2 detection assay for as many as 1,152 saliva samples using a single MiSeq Micro flow cell. The assay uses PCR to simultaneously amplify, index, and adapt SARS-CoV-2 specific regions for sequencing. This method enables a significantly higher assay throughput than what is realized by standard PCR-based approaches and allows for the inclusion of additional targets for relevant SARS-CoV-2 mutations of interest as needed. 

Dr. Ellis will describe how his work at Fry Laboratories, in collaboration with Beckman Coulter Life Sciences, is using economical and nimble NGS-based assays to fill gaps in its capabilities as it works to reduce the impact of SARS-CoV-2. 

He will also discuss how the combined capabilities across prokaryotic, eukaryotic, and viral detection using a unified NGS-based technology enabled by scalable solutions represents a new horizon in molecular microbiology.

Sponsored by
Genome Webinar

Staff Scientist
Director, University of Arizona Genetics Core

Executive Director, UAHS Biorepository,
Office of the Senior VP for Health Sciences
University of Arizona

As the number of global cases of COVID-19 surpass 100 million, experts continue to call for rigorous population testing as a necessary measure to contain the spread of this infection that can move swiftly and silently.

In this webinar session, Dr. David Harris and Dr. Ryan Sprissler, who led the student and employee testing program at University of Arizona, will discuss how the university remained physically open with nearly 25% of its population on campus, while keeping infection rates below 2 percent. This is particularly challenging with a student body that can be asymptomatic and is not rigorous about social distancing and masking compliance.

To keep infection rates low, the University of Arizona has implemented frequent testing, rapid return of results and strict compliance with regards to quarantining when infection is detected.


  • The importance of frequent testing to locate and isolate contagious individuals to reduce infection rates;
  • Guidance on developing a mass screening program: how often and who to test; and how to deliver results in time to prevent the spread of infection;
  • Learnings from experiences on running a mass screening program in a university with a largely young population;
  • The successful protocol to run thousands of COVID-19 antigen tests every day with supplemental PCR and antibody testing;
  • The successful framework to centralize specimen collection sites to increase testing compliance and optimize for high throughput testing and stringent QC oversight.
Sponsored by
Genome Webinar

VP, Product Development,
Mammoth Biosciences

Head of Strategic Implementation & Marketing – CMO,

This webinar will outline the development and commercialization journey of a novel CRISPR-based SARS-CoV-2 test. 

Mammoth Biosciences developed the test in response to the COVID-19 pandemic. The company was one of one of seven chosen to receive funding through the National Institutes of Health’s RADx program to support development and commercialization of the test.  

Tim Patno, vice president of product development at Mammoth Biosciences, will discuss Mammoth’s novel CRISPR-based technology as well as the company’s partnership with MilliporeSigma to manufacture its DETECTR BOOST SARS-CoV-2 Reagent Kit. Patno will discuss the steps Mammoth took to vet and choose a manufacturing partner within the context of commercializing a novel in vitro diagnostic.

Attendees will learn:

  • The basic technology and platform of the CRISPR-based SARS-CoV-2 DETECTR test.
  • The steps in the commercialization process of an IVD; from scope of work through to development, engineering, validation, and closing.
  • Advantages of working with a commercial partner to expedite kit development and launch.


Sponsored by
Genome Webinar

Professor, Epidemiology; Director, Infectious Disease Epidemiology Certificate Program
Columbia University Medical Center

Assistant Professor-Clinical in the Department of Pathology, Associate Director of the Molecular Pathology Laboratory
Ohio State University Wexner Medical Center

Senior Medical Director
Thermo Fisher Scientific

Global genetic surveillance is vital for understanding the evolution of viral pathogens and monitoring for changes in transmissibility, virulence, disease pathology, and impact on the efficacy of diagnostic tests, therapeutics, and vaccines. As such, global surveillance plays a central role in proactively managing pathogens such as SARS-CoV-2, the virus that causes COVID-19. 

Similarly, local genetic surveillance offers an opportunity to understand the evolution of the virus in the community and take actions to manage transmission and monitor evolution at the local level. Robust data about which strains are common, where they are spreading, how their symptoms differ, when new variants are emerging, and more can enable communities, states and countries to better prepare for their arrival. 

Vaccine and test manufacturers are guided by this information as well, cutting weeks or even months from any response they need to make. Genetic surveillance already exists on a large scale to enable scientists to determine which influenza strains are appropriate targets for each year’s flu vaccines, and a similar effort will be needed to make sense of SARS-CoV-2 and its evolving strains.

This webinar will focus on genetic surveillance of the emerging variants of SARS-CoV-2, provide an update on the trending variants, explain the risks of the rise of escape mutants, and outline best practices to establish both global and local surveillance programs, including technologies used for monitoring viral evolution, such as next-generation sequencing.

Learning Objectives:

  • Hear from a leading expert in infectious disease epidemiology regarding emerging variants of SARS-CoV-2.
  • Receive up-to-date information on the state of emerging variants, the impact of selective pressures, and the associated evolutionary advantage conferred to the virus.
  • Learn about best practices in standing up global and community surveillance efforts.
  • Hear from a thought leader in molecular pathology who harnessed his expertise in molecular genetics to contribute to surveillance efforts on a local level.
This webinar is the second in a two part series on Public Health and Emerging SARS-CoV-2 Variants: Implications and Responses.
Sponsored by
Genome Webinar

Professor in Microbial Evolutionary Genomics, University of Birmingham
Infectious Disease Lead for the Milton Keynes Lighthouse Lab UK

Professor of Medicine at KU Leuven, Department of Microbiology and Immunology, Co-Director Infectious Diseases Centre
University Hospital of Leuven

Senior Medical Director
Thermo Fisher Scientific

Viruses mutate as they strive to thrive in response to selective pressures. For molecular diagnostic assays to serve in the management of viral transmission, they need to be designed anticipating the emergence of mutations.

This webinar will focus on the impact of emerging viral variants of SARS-CoV-2 on molecular diagnostic testing. In the first part of the session, Dr. Alan McNally will share how the B.1.1.7 variant was discovered in the United Kingdom, highlight the role played by a molecular diagnostic assay in its detection, and discuss design principles that aid in the development of effective and robust molecular diagnostic assays. In addition, Dr. McNally will discuss some of the clinical data associated with the B.1.1.7 strain as well as the importance of early identification of this variant of concern.

In the second part of the session, Dr. Emmanuel André will discuss his approach to identifying specific SARS-CoV-2 variants using a targeted mutation panel as a reflex test following a suspect clinical variant result. Dr. Andre will provide details about the mutation panel composition as well as the advantages of using this approach for wide-scale SARS-CoV-2 surveillance.

Learning Objectives:

  • Hear the story of detecting the B.1.1.7 variant (UK variant) from a world-leading epidemiologist.
  • Understand the importance of early detection of viral variants and the impact of emerging variants on global response efforts.
  • Learn about molecular diagnostic assay design principles to safeguard against unexpected false results due to mutations and the means to monitor assays as early indicators of emerging variants.
  • Learn about the S-gene advantage with B.1.1.7, the role of the S-gene dropout, and the value of a targeted mutation panel as a reflex tool as follow up for a suspected clinical variant.
Sponsored by
Genome Webinar

Laboratory Head
IMD Labor Frankfurt


Vice President, Scientific Affairs
Agena Bioscience

As new variants of SARS-CoV-2 circulate around the globe, there is growing concern among clinical laboratories that these variants may impact their ability to accurately detect the virus.  Understanding the impact of these variants on molecular testing methods and how labs can address this added complexity is important to managing the diagnostic response to the ongoing pandemic.

In this webinar Dr. Martin Stürmer of IMD Labor Frankfurt will discuss the effects of emerging SARS-CoV-2 variants on diagnostic methods and the clinical utility of detecting and discriminating them. Thomas Alef of Seq-IT will then present how his clinical lab was able to react to the emergence of new, often more contagious, variants of the virus by rapidly designing a highly multiplexed SARS-CoV-2 variant panel using the low-cost, high-throughput MassArray System from Agena Bioscience.

Sponsored by
Genome Webinar

Director, Strategy and Business Development,
Qorvo Biotechnologies

VP Business Development,
Schott Minifab

Developing a fully integrated consumable cartridge for an automated diagnostic platform is a significant challenge. More challenging still is developing such a cartridge in response to a deadly global virus pandemic amid market uncertainty and extraordinary time constraints. 

This has been the case with the development and quick manufacturing scaleup of Qorvo's COVID-19 test. Primary among these challenges has been acquiring and coordinating broad multidisciplinary expertise among Qorvo’s team of people and partners; successfully cultivating the capabilities and culture to be flexible and innovative in face of extreme uncertainty; and, lastly, developing access to broad manufacturing scalability to accommodate the flexibility needed from product development to high-volume manufacturing.

This webinar will present a case study outlining Qorvo's path in developing and commercializing its COVID-19 test. In so doing, participants can expect to learn:

  • Key challenges of diagnostic test development, both anticipated and unanticipated
  • Relevant factors during development that are important to eventual successful commercialization
  • Perspective on the need for development and manufacturing partners and what capabilities they should possess.
Sponsored by
February 23, 2021
Sponsored by
Thermo Fisher Scientific

After the Surge: Driving Sample Processing Efficiency of Coronavirus Samples

Genome Webinar

R&D Scientist IV,
ARUP Laboratories

Director, Clinical Product Development, Thermo Fisher Scientific

As the world continues to contend with coronavirus and a surge in the infection rate, labs are required to run more samples than ever before. Labs face new challenges such as having to process large volumes of samples with a quick turnaround time, the constant risk of falling into backlog, and the possibility of loss of reimbursement (for certain samples). But what happens after the surge, when infection rates decline but testing will still be a necessary component of managing the virus? 

During this presentation, Weston Hymas of ARUP Laboratories will discuss the clinical validation of a SARS-CoV-2 sample pooling protocol that can be used to exponentially increase testing efficiency, enabling a higher volume of sample processing in lower prevalence rate populations. This method can be implemented by clinical labs for routine processing of samples from populations with low infection rates. 

Sponsored by
Partner Webinar

Clinical Molecular Geneticist
University Health Network

Development Technologist II and Assistant Professor in the Genomics Laboratory, Mayo Clinic

VP of Clinical Product Management and Marketing, Qiagen

Technical Director,  Pangaea Oncology; Quiron Dexeus University Hospital

Please join GenomeWeb and Qiagen for an on-demand roundtable discussion where a panel of experts reviews challenges and opportunities around genomic variant interpretation workflows in the field of oncology.

Recently, GenomeWeb and Qiagen partnered on a survey that allowed participants to assess their oncology variant interpretation workflows. This webinar presents the results of the survey and offers an interactive environment for clinical labs to assess their own variant interpretation capabilities.

The discussion covers a range of capabilities related to variant interpretation workflows, including:

  • Resources and skills
  • Workflow optimization
  • Variant interpretation content knowledge.
Sponsored by
Partner Webinar

In this technical presentation, we will discuss the use of polymeric microspheres in diagnostic assays. We will provide you with a survey of the materials used in this field, examples of readers available for this growing market, case studies, and a first preview of novel products to be released in 2020.  Material considerations to be discussed include key attributes needed to select the best spheres for qualitative and quantitative assays (such as size, functional group, and color).  We will also share best practices to troubleshoot protein binding in qualitative assay development using our raw materials. This information will be of interest to individuals involved in developing and validating qualitative and quantitative assays.

Sponsored by
Partner Webinar

Having been on the market for over 25 years, lateral flow test strips are widely accepted as a format for the development of diagnostic assays. Devices range from simple test strips dipped into a sample to long format tests used with quantitative readers.

Lateral flow test strips are easy to run, often requiring no more than application of a liquid sample, but reliability of performance depends on how consistently the strips are constructed. This involves the materials, the chemistries, the overall design, and the assembly processes.

This on-demand webinar discusses some of the critical features of test strip design that affect the consistency of performance. These are related back to strategies for minimizing variation where possible and managing variation where it must be accepted.

Sponsored by
Partner Webinar

In this technical presentation, we will provide you with an introduction to AnteoBind nanocoating technology and the use of AnteoBind activated Estapor europium microspheres in lateral flow immunoassays.

We will discuss the common issues encountered in antibody conjugation, the detail of the alternative protein conjugation procedure using AnteoBind activated Estapor europium microspheres, and the effects of physical characteristics (size, dispersity, surface charge) during the steps of conjugation and storage. We will also discuss the performance of conjugates in functional assay development for several popular biomarkers.

We will share best practices to troubleshoot antibody conjugation to AnteoBind activated Estapor europium microspheres in assay development and the initial scale-up procedure. This information will be of interest to individuals involved in developing and validating lateral flow immunoassays and manufacturing process development.

Sponsored by
Genome Webinar

Director, Genome Center,
University of California at Davis

Senior Field Application Scientist,

Director, COVID Diagnostics Strategy and Market Development,
LGC, Biosearch Technologies

Diverse components of the UC Davis campus have been mobilized to deploy HTP testing to provide a safe working environment and keep the pandemic under control. These efforts are being integrated with the Healthy Davis Together initiative, which is providing free testing for everyone in the City of Davis. The goal is to provide at least weekly testing combined with more frequent strategic testing. This requires rapid data analysis software that minimizes the time needed to accurately call, certify, and return results. 

In this webinar, Prof. Richard W. Michelmore, director of the Genome Center at UC Davis, will describe how his team based its approach on workflows developed in the agricultural biotechnology sector that are capable of cost-effectively generating millions of data points per day. 

Prof. Michelmore will discuss details of the entire workflow, from sample collection through to a data management system that his team developed that uses Ugentec’s Fastfinder software. 

After Dr. Michelmore’s presentation, James Grayson of UgenTec will briefly discuss FastFinder, which allows labs and assay providers to build sample-to-result workflows. 

After this, Ross Higgins of LGC, Biosearch Technologies will briefly introduce how their instrumentation solutions support very large scale screening initiatives.

The presentations will be followed by an interactive Q&A session with attendees.

Sponsored by
Genome Webinar

Director, Englander Institute for Precision Medicine,
Weill Cornell Medicine

Senior Manager of Genetic Epidemiology,
AncestryDNA, LLC

Director, Division of Cancer Epidemiology and Genetics,
National Cancer Institute

Director, Institute of Biochemistry; Group Leader, Biochemistry and Systems Biology of Metabolism,
Charité University Medicine

The unfolding of the COVID-19 pandemic has shown that disease severity does not always correlate with age, preexisting medical conditions, or other clinical features. While some individuals can be infected with SARS-CoV-2 with few or no symptoms, others become severely ill with the disease.

This panel discussion will explore a variety of ongoing research projects and approaches that aim to discover genetic and other biomarkers to help predict who is at risk of developing severe COVID-19.

Our expert panelists will discuss how they are approaching this research challenge as well as the longer-term goals of their work. The discussion will address the opportunities and challenges of implementing their findings into clinical care, particularly within the context of other predictors of disease severity. The roundtable discussion will be followed by a live question-and-answer session with attendees.

Sponsored by
November 10, 2020
Sponsored by
LGC, Biosearch Technologies

IVDR in Light of the COVID Pandemic: The Near Future of In Vitro Diagnostic Testing

Genome Webinar

Founding Partner,
Axon Lawyers 

The COVID-19 pandemic created a paradigm shift in modern healthcare, where regulations, protocols, and mindsets had to be reworked in just a matter of months to keep up with the pace of the virus. In particular, the in vitro diagnostic (IVD) market experienced a dynamic never seen before: SARS-CoV-2 tests were developed at a record-breaking pace amid global supply shortages as labs struggled to keep up with unprecedented demand.

Although the pandemic is far from contained, the next challenge for the global IVD market lies around the corner. In Europe, the new Medical Device Regulation and IVD Regulation (IVDR) goes into effect on May 26, 2022, and will bring significant changes to the IVD testing space, with CE certification by a notified body becoming the rule rather than the exception and a new strict EU regime for in-house developed tests. Moreover, the Brexit transition period ends in December this year and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued post-Brexit guidance on IVD in the UK. This will not only impact IVD manufacturers, but also have far-reaching consequences for supply chain and distribution, notified bodies, as well as clinical laboratories who are operating in Europe.

In this webinar, Erik Vollebregt, an expert in IVD law from Axon Lawyers, will bring you up to speed on the IVDR and will discuss the impact of the current COVID-19 pandemic on future IVD testing.

Attendees of this webinar will learn:

  • Basic outlines of the new EU IVDR regime.
  • New IVDR requirements around component specifications and maintenance.
  • Impact of the IVDR regime on supply chain and in-house developed tests.
  • EU emergency guidance in the field of IVD development.
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