• Understand reverse transcription quantitative PCR (RT-qPCR) technology and growth potential 

• Review the opportunities and challenges for extraction-free methods 
• Discuss a robust extraction-free chemistry optimized for One-Step RT-qPCR for detection of RNA. 

• Understand the role of government agencies and regulatory bodies in the development of diagnostic tests
• Review the impact of unexpected global health trends on the approval of novel tests  
• Consider the timelines, steps, and challenges in the regulatory approval process 
• Learn how to work with regulators for successful filing.  

• Discuss the differences between sandwich and competitive tests and how to choose between them
• Understand the key considerations in membrane and reagent selection
• Review the critical processes including conjugation, lamination, dispensing and drying that help to improve the reproducibility of quantitative tests.

Immunoassay developers are constantly striving to create tests that address unmet diagnostic needs. A critical prerequisite for good assay performance is the design, production, and characterization of reagents that are highly sensitive and selective. This includes selecting the analyte of interest to measure, the sample matrices in which measurements will be made, as well as determining the critical success factors for the assay, for example, sensitivity, throughput, and dynamic range.

Biacore™ surface plasmon resonance (SPR) has become an important optical biosensing technology due to its real-time, label-free, and automated analysis. Additionally, the robustness and precision of modern SPR instruments has seen the technology widely applied for the rapid and ultra-sensitive detection of biological analytes, with applications in medical diagnostics, environmental monitoring, and agriculture.

This presentation will provide an overview of Biacore SPR as a diagnostic tool, highlighting how it can aid and simplify immunoassay reagent selection and accelerate the development of fit for purpose diagnostic assays.

Learning objectives

• How surface plasmon resonance technology aid the selection and optimization of reagents for diagnostic tests
• How SPR has been applied as diagnostic tool in clinic

Many challenges exist in lateral flow assay (LFA) manufacturing, from low-volume liquid deposition to device assembly and packaging. In the development and batch-level manufacturing stage, antibody and conjugate selection, material selection, and reagent delivery are critical. In addition, batch-level manufacturing is typically segmented and requires manual quality control (QC) and material assembly. When transitioning from low-volume manufacturing to mass-production, there are a different set of challenges presented, particularly in maximizing throughput without sacrificing quality. In addition, material handling and assembly, automated QC, and drying are critical in the large volume production. Critical to successful lateral flow production is the transition from the batch to mass-production phases.

In this webinar, you will:

• Learn unique challenges and solutions to reagent deposition
• Learn the process and techniques used in batch-level LFA manufacturing
• Learn the unique challenges presented in large-scale LFA manufacturing as well as solutions to achieve a high-quality product while balancing throughput and efficiency
• Learn strategies for scale-up from batch manufacturing to mass-production

Cell-free DNA (cfDNA) is currently trending as a biomarker from liquid biopsy in several clinical applications, including oncology, organ and transplant medicine, and non-invasive prenatal testing (NIPT). Although considerably less invasive than tissue biopsy, due to the small amount of cfDNA found in circulation, there is a need to use efficient, highly sensitive extraction protocols coupled with robust and reliable technologies, such as next-generation sequencing (NGS) to detect these mutations.

Join our webinar hosted by Monika Seidel (PhD) to discuss the results of a study using Cytiva’s magnetic silica bead-based Sera-Xtracta™ Cell-Free DNA extraction kit* and targeted NGS for cancer biomarker detection in advanced non-small cell lung cancer (NSCLC) patient samples. The study demonstrates performance in a clinically relevant scenario where patient samples are analyzed for therapy stratification.

Learning objectives

• Discuss the opportunities and challenges created with liquid biopsy samples
• Review the impact of cell-free DNA extraction efficiency, yield and purity in downstream applications such as next-generation sequencing 
• Demonstrate performance of Sera-Xtracta Cell-Free DNA Kit in a clinically relevant scenario where patient samples are analyzed for therapy stratification

• Review the importance of security of supply and the consequences of failures in the supply chain
• Discuss the importance of data in analyzing supply risk and be introduced to the sourcing risk finder tool and the measures that can be developed to mitigate supply risk levels, even during unprecedented times
• Consider product and workflow decisions that can help reduce supply risks and future trends and considerations in security of supply

Dried blood spot (DBS) have been used as an alternative to plasma to increase access to HIV viral load monitoring and early infant diagnosis. DBS has also been applied as a sample collection method to detect SARS-CoV-2 downstream. Recently, the FDA approved the Vibrant COVID-19 antibody chemiluminescence immunoassay. The intended use is for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum on Whatman™ 903 Proteinsaver Card (a sample collection card) using finger stick blood specimen.

In this webinar, Dr. Zahidul Mondle will present on:

• the diverse application of DBS
• the use of Whatman 903 Proteinsaver cards
• important considerations when defining a sample collection strategy

• Discuss the cost, workflow and environmental benefits of lyophilization
• Review Cytiva’s Lyo-Stable technology and expertise
• Hear about the development of temperature stable tests and PCR based assays using Lyo-Stable technology

• Review a workflow showing that shallow sequencing of crude cell lysates reproducibly detects over 5000 genes with at least 10 reads.
• Demonstrate how subsampling of deep sequencing datasets shows that differential pathway analysis is largely unaffected when reducing the number of genes to this level.
• Discuss cell perturbation screenings and the ways this methodology can be applied to repurpose off-target siRNA hits from library screens to reveal novel candidate therapeutic targets for drug development.
• Demonstrate how coupling the data generated from the workflow with a tailored visualization platform can facilitate data interpretation.

• Discuss the technology behind magnetic bead chemistry
• Understand the range of surface chemistries and sizes available to meet different application requirements
• Review how magnetic bead customization and conjugation can help to streamline the genomics workflow and expand the range of molecular diagnostic applications available

Lateral flow assays are unrivaled among rapid tests when it comes to speed and ease of use. Their development, however, requires highly informed decision making, including careful selection of the nitrocellulose membrane and other key components. Getting this approach right helps speed up the iterative assay development process, leading to an optimal solution that minimizes the risks of late setbacks and costly re-testing and re-validation. Join this webinar to hear:

• A simple introduction to lateral flow tests
• The important factors and considerations for robust design
• Guidance on selecting the correct materials
• FAQs and examples of common issues (and how to resolve)

During development it is vital to have an understanding of how you are going to manufacture your product once you get through the R&D process, but it is important that you include a Contract Manufacture Organisation (CMO) in your process as early as possible. Please join Jon for this session to understand common pitfalls to be avoided, suggestions for streamlining the transfer process and how a CMO could accelerate the market acceptance of your product.

• Learn how to check sample quality against set criteria and assess the potential impact on data outcomes in relation to genomic and prenatal testing applications
• Review modifications to workflows, protocol steps and NGS analysis to manage the quality of complex samples such as FFPE and liquid biopsy
• Understand the benefits and drawbacks of different approaches to nucleic acid isolation with particular focus on column-based and magnetic bead-based approaches
• Compare the benefits and drawbacks of different approaches to nucleic acid isolation with particular focus on column-based and magnetic bead-based approaches

Lateral flow assays are unrivaled among rapid tests when it comes to speed and ease of use. Their development, however, requires highly informed decision making, including careful selection of the nitrocellulose membrane and other key components. Getting this approach right helps speed up the iterative assay development process, leading to an optimal solution that minimizes the risks of late setbacks and costly re-testing and re-validation. Join this webinar to hear:

• A simple introduction to lateral flow tests
• The important factors and considerations for robust design
• Guidance on selecting the correct materials
• FAQs and examples of common issues (and how to resolve)