GenomeWebinars

This webinar will address the need for innovation in the early detection of cancer and the approach taken by Elypta, a Swedish cancer detection firm, to develop new metabolism-based biomarkers.

Elypta was funded by the EU Horizon 2020 program to bring the first kidney cancer recurrence test to market. Elypta’s approach is based on profiling glycosaminoglycans — or the GAGome — and developing scores indicative of cancer. At the 2021 American Society of Clinical Oncology conference, a proof-of-concept study across 14 cancer types revealed the broader potential for early detection using the technology, highlighting the sensitivity to stage I disease.

Karl Bergman, CEO of Elypta, will discuss the need for new cancer biomarkers and Elypta’s results highlighting the potential of glycosaminoglycans as a tool in early detection. He will also outline the path Elypta took to develop their research-use-only (RUO) kits, partnering with MilliporeSigma at an early stage to ensure a clear path to large-scale in vitro diagnostic (IVD) manufacturing and enabling the Elypta team to focus their efforts on research and development.

Michael Mitchell, commercial project manager at MilliporeSigma, will discuss the milestones and challenges of MilliporeSigma’s work with Elypta. Mitchell will cover highlights from the set-up, pilot, and engineering phases of Elypta’s RUO cancer detection kit, as well as the preparative work for their IVD offering.

Attendees will learn:

• Why more biomarkers are needed for the earliest stages of cancer
• Key aspects and results from the GAGome-based liquid biopsy platform developed by Elypta
• How a partnership with MilliporeSigma helped Elypta in the development journey

As the COVID-19 pandemic rages on, data have shown that other aspects of healthcare are being neglected by patients and physicians alike, including practicing good stewardship to battle antibiotic-resistant bacteria. Earlier this year, the US Centers for Disease Control noted that COVID-19 can create a "perfect storm" for antibiotic-resistant infections in healthcare settings due to longer hospital stays, staffing shortages, a higher number of sick patients, and difficulties implementing infection control practices. The CDC also noted that the number of bacterial and fungal specimens and isolates received and/or tested in 2020 by CDC's antibiotic resistance lab network was about 23 percent less than 2019 levels.

More recently, in September, a CDC study published in Infection Control and Hospital Epidemiology revealed initial increases early in 2020 for ventilator-associated events (VAEs), central line-associated bloodstream infections (CLABSIs), and methicillin-resistant Staphylococcus aureus (MRSA) bacteremia. In addition, compared to 2019, the second half of 2020 saw large and significant increases in catheter-associated urinary tract infections, VAEs, CLABSIs, and MRSA bacteremia.

Although it is still unclear whether this is a burgeoning trend or a blip on the radar, molecular testing remains one of the most important public health tools available for keeping antibiotic resistance in check. In this roundtable discussion, researchers and lab directors from four highly renowned US academic institutions and healthcare organizations will share their thoughts on what they're seeing on the antimicrobial stewardship front; the role of molecular testing in combatting AMR; what challenges they are seeing in their organizations; and what tools and technologies are available or on the horizon to help with the fight.

The session will include a live Q&A in which attendees can post questions to our panelists: Kevin Alby, Ph.D., D(ABMM) (Assistant Professor, Pathology and Laboratory Medicine Director, Bacteriology and Susceptibility Testing, Associate Director, Clinical Microbiology Laboratory, UNC School of Medicine, Chapel Hill, NC); Romney M. Humphries, Ph.D., D(ABMM), M(ASCP) (Professor of Pathology, Microbiology, and Immunology Medical Director of the Microbiology Laboratory); Dr. Patricia Simner, PhD, D(ABMM) (Associate Professor of Pathology at the Johns Hopkins University School of Medicine, Director of the Medical Bacteriology and Infectious Disease Sequencing Laboratories at the Johns Hopkins Hospital); Glen Hansen, PhD (Hennepen Healthcare).

Nearly 70 years after the discovery of cell-free DNA, plasma genotyping is routinely used to non-invasively detect and quantify clinically relevant point mutations, insertions/deletions, amplifications, rearrangements, and aneuploidy. Over the past eight-plus years, strong concordance has been shown between plasma and tissue-based genomic assays, encouraging the clinical adaptation of plasma genotyping. In this webinar, Dr. Cloud Paweletz will present institutional experiences implementing liquid biopsies into non-small cell lung cancer. He will discuss technical limitations and lessons learned with a particular focus on minimal residual disease, treatment response, and the emergence of resistance monitoring. The realization of these lessons, however, spurs significant investment in techniques and technologies to increase specificity and sensitivity and reduce turnaround time and cost for further clinical adoption of this promising diagnostic.

Next-generation sequencing of infectious agents is crucial for large-scale genomic surveillance of infectious diseases. Throughout the SARS-CoV-2 pandemic, several consortia across the globe have coordinated efforts to understand the epidemiology of SARS-CoV-2 through the identification and tracking of novel variants in cases of positive patients. In this webinar, we highlight the collaboration between the European Molecular Biology Laboratory (EMBL), New England Biolabs (NEB), and Beckman Coulter Life Sciences to develop an automated high-throughput NGS library prep workflow for SARS-CoV-2 surveillance using the NEBNext ARTIC SARS-CoV-2 Library Prep Kit (Illumina) and the Biomek i7 Hybrid NGS Workstation.

Someone with untreated latent tuberculosis infection (LTBI) and diabetes is more likely to develop tuberculosis (TB) disease than someone without diabetes. Without proper treatment, diabetes and TB can increase health complications.

In this webinar, Dr. Sonia Qasba will journey through the epidemiology, risk, and treatment recommendations of diabetic patients with LTBI. She will discuss how diabetes potentiates TB and why TB predisposes one to hyperglycemia. Additionally, she will share real-life examples of screening, prevention, and treatment of individuals with LTBI, TB, and diabetes.

Cell-free (cf)DNA screening of pregnancies (also known as non-invasive prenatal testing or NIPT) is a transformative technology that is becoming routine for all pregnancies. Laboratories are potentially faced with adding a new technological approach in order to add NIPT to their repertoire of assays. Laboratories may choose from whole-genome NGS methods or more targeted methods. Furthermore, there are evolving regulatory requirements, a lack of test standardization around the world, and few validation studies targeting rare disorders. Clinical laboratory directors also need to anticipate the complexities of interpreting results from an inconclusive finding or disentangling biological considerations such as placental mosaicism from analytical performance considerations. However, NIPT is still a screening test, and thus confirmation by amniocentesis or chorionic villus sampling and diagnostic testing is required.

In this webinar, expert panelists, Jillian Buchan, PhD FACMG; Glenn Palomaki PhD; Kaarel Krjutškov PhD; and Russell Garlick, PhD will discuss recent experiences adopting NIPT testing for routine use, designing and executing complex validation studies, and interpreting unexpected results.

Panelist presentations will be followed by a discussion of current topics and audience questions. 

The use of next-generation sequencing (NGS) technologies in the field of infectious diseases has transformed the way pathogens are detected and characterized. Metagenomic sequencing provides a comprehensive and high-resolution analysis of microbial genetic material including bacteria, fungi, viruses, and parasites that is independent from microbial culture. The main challenge of developing a metagenomic sequencing assay is the efficient and unbiased recovery of microbial nucleic acids from degraded samples.

The Karius Test is a liquid biopsy that can non-invasively and rapidly detect over 1,000 pathogens from a single blood sample. When developing the Karius Test, scientists at Karius not only encountered challenges unique to metagenomics but unique to the biomarker that makes the test non-invasive; microbial cell-free DNA (mcfDNA). These challenges include working with degraded samples, unbiased detection of all mcfDNA in the sample, removing host and contaminant nucleic acid, and a streamlined workflow that accommodates a fast turnaround time. Tecan’s patented NGS library preparation technologies have supported laboratories like Karius to develop transformative genomic assays that uncover insights from even the most challenging samples.

In this webinar, Dr. Tim Blauwkamp, Chief Scientific Officer at Karius will discuss:

• Challenges in developing a cell-free DNA metagenomic sequencing assay.
• Approaches to solving these challenges for a liquid biopsy test for infectious diseases.
• Collaboration with Tecan to recover fragments efficiently and without bias in degraded samples.

Tecan genomics reagents are for Research Use Only. Not for diagnostic procedures.

The Karius Test was developed and its performance characteristics determined by Karius. This test has not been cleared or approved by the FDA, nor is it required to be. The Karius laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) and is accredited by the College of American Pathologists (CAP) to perform high-complexity clinical laboratory testing.