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Genome Webinar

Director, Genome Center,
University of California at Davis

Senior Field Application Scientist,
UgenTec

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.
Sponsored by
Partner Webinar

Professor of Molecular Oncological Pathology,
University of Groningen

Consultant Clinical Scientist and Director,
Genomics Quality Assessment

Scientific Associate
Institute of Pathology, Charité – Universitätsmedizin Berlin

This webinar features a panel of industry stakeholders in cancer diagnostics, proficiency testing and clinical care who will discuss the promise and challenges of liquid biopsy technologies in disease diagnosis, monitoring, and patient care management.

The application of plasma samples bearing circulating tumor DNA (ctDNA) as a surrogate for solid tumor biopsy is an area of significant research and clinical interest. Genomic aberrations associated with ctDNA have been demonstrated to mirror the solid tumor mutational landscape and have the potential for early diagnosis of cancer as well as monitoring and tracking biomarkers associated with residual disease and/or recurrence.

Despite this promise, there are still open questions regarding the best way to implement liquid biopsy approaches in the clinical setting. Our panel brings together academic, clinical, and industry experts in liquid biopsy technologies who will describe the applications of this technique and discuss its benefits and shortcomings in the context of cancer disease management.

Sponsored by
Genome Webinar

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections. The agency's policies for granting EUAs for both molecular and antibody tests evolved over time as more was learned about SARS-CoV-2 and its spread, and diagnostics firms and labs needed to adapt to these changes.

Dr. Elizabeth Hillebrenner, associate director for scientific and regulatory programs at the FDA's Center for Devices and Radiological Health, will kick off this virtual roundtable with an overview of the EUA program, how it evolved, and how lessons learned during the current pandemic may shape future policies and actions by the FDA. She will then take part in a panel discussion that will include a variety of stakeholders from the diagnostics and clinical lab industries. Panelists will include Dr. Robert Boorstein, Medical Director of Lenco Diagnostic Laboratories; Danelle Miller, VP, Global Regulatory Policy and Intelligence for Roche Diagnostics; Dr. Jeffrey Klausner, Professor of Medicine and Public Health at UCLA David Geffen School of Medicine and Fielding School of Public Health; and Gail Javitt, Director at Hyman, Phelps & McNamara.

Sponsored by
Partner Webinar

Chief Medical Officer, Bionano Genomics

Clinical Associate Professor, Obstetrics & Gynecology, Maternal Fetal Medicine


Consultant Clinical Scientist
Director of GenQA

Non-invasive prenatal testing (NIPT) continues to expand globally to support maternal-fetal patient care. With a growing number of available assays and more labs offering testing, it is essential to have consistency in reporting and the ability to compare results and validate current or new methods.

This on-demand webinar features a panel of experts who provide key insights into the current needs in prenatal testing, the complexities of selecting an assay format and performing quality control, as well as other challenges that labs face when setting up and validating an NIPT assay.

The panelists bring a wealth of expertise and differing viewpoints in clinical laboratory practice, diagnosis of pregnancy complications, and new molecular methods for diagnosis and treatment of pregnancy anomalies and complications. 

Sponsored by
Genome Webinar

Technical Director,
Weck Laboratories

Product Manager, PCR and qPCR Reagents,
Agilent Technologies

Surveillance analysis of potentially pathogenic microbes found in shared public resources is an important component of research aimed at understanding, preparing for, and protecting communities from potential widespread infection and transmission of infectious diseases. For example, wastewater testing for SARS-CoV-2 has emerged as an efficient, cost-effective, and reliable method for assessing and estimating population infection levels. This approach may provide data to develop predictive modeling tools, enabling hospital and ICU occupancy trend analysis in the future. 

The fastest and most affordable method to date for quantitative viral detection is the quantitative reverse transcriptase PCR (qRT-PCR) assay. This webinar will discuss background, technique, reagents and instrumentation used in wastewater testing as it applies to SARS-CoV-2 research, as well as implications for analysis of other pathogens and infectious diseases.

Disclaimer: Agilent products are NOT approved for COVID-19 testing, diagnosis, treatment, or mitigation. Agilent has not validated a product to detect the novel coronavirus.

Genome Webinar

This webinar will present a case study from in vitro diagnostics developer SpeeDx on its experience building a complete sample-to-result workflow — encompassing instrumentation and data analysis software — for its qPCR-based ResistancePlus MG Mycoplasma genitalium assay.

Data analysis software has become an integral component of in vitro diagnostic assays in general, and molecular diagnostic tests in particular. The ability to provide a software solution for end users that accurately reports results, identifies technical issues, and can be integrated with a laboratory’s information systems can be as important in the final decision about whether to adopt a given platform as analytical and clinical performance data.

Another important consideration for molecular diagnostic development is the decision whether to develop a novel instrument or to leverage a third-party open platform. Considerations not only include size or price, but also the global installed base, available service plans, options for instrument placement and reagent rental. These choices impact capital efficiency, time to commercialization, and accelerated adoption of the assay in the market. 

SpeeDx is a developer of innovative multiplexed molecular diagnostic assays that employ a novel PCR technology (PlexZyme). Although the assay chemistry is flexible and instrument agnostic, the company needed a customizable software application that could take unique data feeds from different instruments and turn them into accurate reportable results with minimal involvement from end users.

This presentation will discuss the partnership between SpeeDx and Ugentec to produce an integrated data analysis solution for SpeeDx customers running the assay on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument , covering the key elements of the Ugentec software. 

After the main presentation, UgenTec will briefly discuss its FastFinder software platform that allows labs and assay providers to build sample-to-result workflows and Thermo Fisher Scientific will briefly introduce its instrumentation, reagent, and services portfolio for assay development. The presentations will be followed by an interactive Q&A session with attendees.

Sponsored by
Genome Webinar

As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity. Traditionally such efforts have relied solely on clinical testing of individual patients. But recent reports demonstrate that a proportion of the individuals infected with SARS-CoV-2, the virus responsible for COVID-19, shed viral RNA into feces providing the opportunity to surveil wastewater to monitor the presence and trends of SARS-CoV-2 infection within a community. This practice, known as wastewater-based epidemiology (WBE), has been previously used to monitor public health status for a number of viruses including poliovirus, norovirus, hepatitis A, hepatitis E, and aichi virus.  Importantly, initial studies indicate that SARS-CoV-2 RNA shedding in feces is agnostic to symptom severity, which indicates WBE could provide less biased public health monitoring than clinical testing alone. 

In this webinar, Aaron Bivins of the University of Notre Dame will describe methods for direct-adsorption extraction and Droplet Digital PCR (ddPCR) for the sensitive and reproducible quantification of SARS-CoV-2 RNA in primary influent samples from two municipalities.  

Raul Gonzalez of Hampton Roads Sanitation District will provide insights on a 20-week study demonstrating that wastewater SARS-CoV-2 concentrations have steadily risen ahead of clinically confirmed cases and propose several ways that data can be presented to be of greatest use to public health officials. 

Together they will highlight the utility of wastewater-based epidemiology to detect and track SARS-CoV-2 infection within a community using Droplet Digital PCR. 

August 12, 2020
Sponsored by
Truvian

Demystifying COVID-19 Antibody Testing

Genome Webinar

Antibody testing is expected to play an important role in the management of the COVID-19 pandemic. With the cluttered landscape of both lab-based and lateral flow serology testing options, it has become challenging to know which way to lean, and where the cross section of accuracy and access lie. 

In this webinar, Dr. Jerry Yeo, Professor and Medical Director of Clinical Chemistry at University of Chicago, and Dr. Stephen Rawlings, Infectious Disease Fellow at University of California, San Diego, will summarize their thoughts on the value, utility and limitations of antibody tests for SARS-CoV-2.  

They will review how rapid lateral flow serology tests work and considerations when choosing a test. They will also share data from their independent studies focused on assessing the performance of lateral flow tests, including a comparison to a standard laboratory serology instrument.

Sponsored by
Genome Webinar

Research Microbiologist-Team Lead
Centers for Disease Control and Prevention Atlanta, GA

Sr. Director of R&D, Thermo Fisher Scientific

Establishing and evaluating proper controls are critical to the success and accuracy of any diagnostic assay. Successful controls increase confidence in a diagnosis by verifying that every step in the diagnostic process is working properly and providing reliable information. The testing volume and supply shortages incurred due to the COVID-19 pandemic have stressed all aspects of respiratory disease diagnosis, heightening the importance of internal and external controls.

Dr. John R. Barnes from the Centers for Disease Control and Prevention will give a  presentation focusing on developing and validating internal and external controls for nucleic-acid based tests for infectious respiratory disease, using the new CDC Influenza SARS-CoV2 Multiplex Assay as an example. The possible effects of shortages and processing changes on diagnosis and the importance of evaluating controls during the COVID-19 pandemic are also discussed.

Tony Prestigiacomo, Sr. Director of R&D at Thermo Fisher Scientific, will then talk about the importance of quality control in serological testing for infectious disease.

Sponsored by
Genome Webinar

This webinar will discuss a study that set to assess the efficacy and safety of osimertinib in EGFR T790M positive non-small cell lung cancer (NSCLC) patients identified by using plasma sample and cobas EGFR Mutation test v2. This is the first prospective study to use liquid biopsy upfront to evaluate osimertinib efficacy.

Takayuki Takahama of Kindai Nara University Hospital will share details of the study, which enrolled 276 patients with advanced or recurrent NSCLC with known TKI-sensitizing mutations of EGFR, had documented disease progression after treatment with at least 1 first- or second-generation EGFR TKI, and were positive for the T790M mutation in plasma.

Dr. Takahama will discuss the results, which demonstrate the utility of liquid biopsy for the detection of T790M with the cobas EGFR Mutation Test v2. Plasma genotyping with this assay is informative for treatment selection in clinical practice when tumor sampling is not feasible. 

July 15, 2020
Sponsored by
LGC SeraCare Life Sciences

Diagnostic Challenges in Cancer Immunotherapy: An Expert Panel Discussion

Genome Webinar

Chief Scientific Officer, Foundation Medicine

Global Head of Medical Affairs,
Clinical NGS and Oncology Division, Thermo Fisher Scientific

President & Chief Technology Officer,  Genosity

Vice President, Assay Development, Illumina

Chief Scientific Officer, LGC SeraCare Life Sciences

Cancer immunotherapy is an exciting new advance for the successful treatment of many forms of metastatic cancer. However, only a minority of patients with terminal cancer have durable response with approved immuno-oncology treatments.

This on-demand webinar features a panel of experts in the field who provide key insights into the current advances in cancer diagnostics and immunotherapy, as well as challenges facing the discipline.

The panelists bring a wealth of expertise and differing viewpoints in clinical laboratory practice, cancer research, translational sciences, and immuno-oncology diagnostics and therapeutics at the molecular and cellular levels important to the care and management of cancer patients and treatment outcomes. Each speaker will have an opportunity to share their perspectives on this topic, which will be moderated by Dr. Russell Garlick, Chief Scientific Officer at LGC SeraCare. The presentation will be followed by a live Q&A to allow attendees to address the experts directly.

Sponsored by
Genome Webinar

This webinar will describe a rapid metagenomics assay under development for human pathogens, including the SARS-CoV-2 coronavirus.

The assay under development at the University of Pennsylvania is based on a microarray platform of 8 arrays by 60,000 probes and detects all known viruses and other pathogenic bacteria, fungi, and parasites, covering more than 6,000 accessions of microorganisms associated with diseases.

The array-based technology can accurately detect an agent of interest, including SARS-CoV-2, in less than 24 hours. The assay includes probes covering all known pathogenic respiratory pathogens, including other coronaviruses from bats and other mammals, providing accurate and efficient detection of SARS-CoV-2 as well as the potential for detection of other respiratory pathogens as co-infecting agents that may contribute to severity of disease. 

Dr. Erle Robertson of the University of Pennsylvania will describe the benefits of the test, which include high accuracy due to the use of multiple probes across the genome, which minimizes negative results from probe failure due to the compensatory signals from other probes in the assay screen. 

Dr. Robertson will discuss his team’s plans to develop the assay to require only a few drops of blood or plasma for detection of the virus.    

Disclaimer: Agilent products are NOT approved for COVID-19 testing, diagnosis, treatment, or mitigation. Agilent has not validated a product to detect the novel coronavirus.

For Research Use Only. Not for use in diagnostic procedures.

Genome Webinar

Professor for Molecular Hematology,
Medical Faculty Carl Gustav Carus, Technical University of Dresden

The invention of novel high-throughput technologies, especially next-generation sequencing (NGS), has spurred our understanding of the development of human cancers and opened new avenues for rapid and comprehensive diagnosis. Especially in hematological malignancies, the availability of these novel high-throughput technologies has greatly enhanced our capabilities for the identification of disease, defining lesions and targets for tailored treatment. At the same time, these diagnostic tools have inherent aspects that make them vulnerable to false positives as well as false negatives. Major aspects are balanced coverage, the rate of detection of long insertions and deletions, as well as the sensitivity of the assay. 

Besides these technical aspects, the comprehensive and adequate interpretation of results, especially in the light of more recent discoveries regarding preleukemic, clonal hematopoiesis, such as clonal hematopoiesis with indeterminate potential (CHIP), adds an additional layer of complexity, which requires a substantial level of expertise to avoid over- as well as underinterpretation of results.

Nevertheless, the important information gained by using NGS-based evaluation of patients for the presence of mutations enables much more comprehensive analysis; identification of disease-defining lesions (e.g., mutations in genes like NPM1, CEBPA, SETBP1); and potential targets for treatment (e.g., cKIT, FLT3) and risk stratification (e.g., TP53, RUNX1 or ASXL1).

In this webinar, Dr. Christian Thiede, Professor for Molecular Hematology at the Technical University of Dresden will discuss the pros and cons of these methods, their appropriate and cost-effective use, as well as aspects to keep in mind for data interpretation will be discussed.

For Research Only. Not for use in diagnostics procedures.

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