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White Papers and Videos

Using Real-World Lab Data Insights to Improve Biomarker Testing in Lung Cancer

White Paper

The medical community’s understanding of lung cancer has become increasingly sophisticated in recent years and, as a result, significant advancements have been seen in targeted therapies for this patient population.

Professional organizations such as the National Comprehensive Cancer Network (NCCN) have remained at the forefront of testing and treatment paradigms based on the latest available data and drug approvals. Guidelines from NCCN for non-small cell lung cancer (NSCLC) are among the most frequently updated, with seven revisions in 2021 alone. While this speaks to the speed of the evolving landscape, it can also create proverbial whiplash among providers of lung cancer patients as they navigate the multitude of testing and treating options available to them.

This white paper from NeoGenomics compares lung cancer biomarker testing rates in the community practice setting with NCCN guidelines, discussing the implications of current testing algorithms on time-to-treatment and tissue availability and how real-world lab data provides evidence-based rationale for building precision oncology programs.

Comprehensive Genomic Profiling: Lowering Barriers to Implementation and Access

White Paper

As precision treatments for cancer expand and guidelines change to recommend new biomarker tests for patients, comprehensive genomic profiling (CGP) assays — NGS-based tests that assess a broad array of cancer biomarkers — can provide several advantages over smaller hotspot or single-marker tests and inform treatment plans that can be quickly adapted in response to new therapies and recommendations. As kits and services become more widely available, CGP testing rates are increasing, with some health systems offering NGS profiling to all late-stage cancer patients.

However, not all cancer patients have access to biomarker tests. Moreover, outcomes do not always improve for patients who are tested, possibly due to delays in appropriate testing or targeted treatment. These issues are due, in part, to challenges in the implementation and operationalization of NGS testing, according to some experts. Complex pre-analytical steps, challenges in test interpretation, inconsistent payor coverage, social disparities in care, long turnaround times, and other issues can sometimes stand between patients and appropriate testing or treatment. Thus, several groups are working to identify and improve implementation and workflow challenges to close the gap between what is technologically possible and the current reality for patients.

This GenomeWeb e-book, sponsored by Roche, draws on Precision Oncology News reporting to summarize the advantages of comprehensive genomic profiling, implementation and workflow hurdles that slow broad implementation, and ongoing efforts to identify and address those challenges.

Overcome the Four Common Data Challenges in Clinical Diagnostics

White Paper

This white paper from Qiagen describes four challenges in scaling NGS test volume —managing high volumes of sequencing data, keeping up with the regulatory landscape, reducing operational costs, and developing and delivering tests quickly — and describes solutions employing the DNAnexus data analysis platform and Qiagen Digital Insights knowledge base.

Lyophilization: The Future of Molecular Diagnostics

White Paper

The need for molecular diagnostic assays is growing at an unprecedented rate. With new biomarkers being discovered and standard catalog reagents becoming more accessible, diagnostic developers and manufacturers can create molecular tests faster than ever before.

Diagnostic assay developers typically design assays using standard catalog reagents available in wet chemistry format because they are widely available, easy to source, and simple to combine with other components in a laboratory setting for optimization.

Although wet chemistry is the traditionally used format, some reagents are not stable at ambient temperatures long-term and therefore need cold chain shipping and handling, adding risk and cost to logistics associated with sourcing the reagents for the test.

This white paper from Fortis Life Sciences highlights lyophilization’s role in addressing some of these common challenges.

How Emerging Technologies are Changing Point-of-Care Product Development

White Paper

This white paper from Invetech discusses how technologies like machine learning, cloud services, and connected devices are transforming point-of-care product development, covering success factors in platform development and deployment, how adopting cloud solutions can improve product design, and ways machine learning can differentiate platforms.

Essential Design Principles to Develop CLIA-Waived Devices

White Paper

This white paper from Invetech discusses meeting FDA criteria for safety, accuracy, and simplicity when developing CLIA-waived point-of-care platforms by researching the user experience early on, employing strategies for incorporating user research into development cycles, and employing a strong human-factors engineering approach.

Design Guide for Creating a Differentiated Point-of-Care Diagnostics Platform

White Paper

The COVID-19 pandemic challenged the in vitro diagnostic business to quickly scale a novel assay and get closer to the point of use in airports, schools, workspaces, and more. Point-of-care diagnostics present a unique opportunity in the decentralization of healthcare. To win the attention of investors and get traction in the market, developers must deliver a platform that is differentiated. It needs to be optimized for a more distributed point-of-care environment and provide a broad range of assays with highly actionable results. At the same time, it’s important to move quickly, as time to market is critical.

This white paper from Invetech discusses important strategies for ensuring point-of-care diagnostic platforms deliver a great user experience, the emerging technologies that are paving the way for breakthroughs in point-of-care platforms, and proven approaches for minimizing total cost of ownership.

Deliver Winning Point-of-Care Products With User-Focused Product Definition

White Paper

Designing for the user is increasingly necessary for point-of-care and in vitro diagnostic manufacturers. Successful products must solve real user problems to deliver value, so discovering the user’s true goals and needs at the start of product development is essential to:

  • Maximize the opportunity for quality innovation.
  • Minimize the chance the product design will need to be revisited later.
  • Reduce the risk a product will be used incorrectly or inefficiently which can impact market acceptance, regulatory clearance, and product safety.

This white paper from Invetech explores how a user-focused product development process can improve system performance and the manufacturing and market success of point-of-care diagnostic products.

Point-of-Care Consumables: 11 Ways to Minimize Costs

White Paper

Consumables are a recurring cost that can make or break the market success of a point-of-care diagnostic device. As a result, device companies must pay close attention to the cost the market will bear and make decisions that keep consumable prices low. That means controlling materials and manufacturing costs and implementing an iterative product development process to minimize development costs. By paying close attention to these two elements, device manufacturers can lower consumable costs, mitigate delays, reduce development times, and more rapidly move their product into the marketplace.

This white paper from Invetech provides strategies for keeping materials and manufacturing costs as low as possible, guidance for balancing tradeoffs between unit costs and time to market, and insights for employing an iterative product design approach that mitigates risks and minimizes development costs in point-of-care diagnostic development.

Five Strategies for Improving POC Device Manufacturability

White Paper

Early in the point-of-care diagnostic product development process, it’s important to be agile and iterate quickly. However, closer to manufacturing, the design needs to be locked down, parts need to be sourced and lead times need to be considered. Waiting until the device design is fully matured before bringing in the manufacturing supply chain risks losing the opportunity to change parts to lower-cost options. Furthermore, changes must be re-verified, which will impact time to market. By embracing a process that integrates both the design and manufacturing teams early on, potential problems can be anticipated and either eliminated or mitigated through design, quality vendor selection, and other means.

This white paper from Invetech outlines five ways design and manufacturing teams can design lower-cost point-of-care diagnostic devices: planning for manufacturing from the start, preparing for production, designing for assembly and manufacturability, sourcing parts and establishing the supply chain early, and refining the process to improve quality and repeatability.

Optimizing Results from Nucleic Acid Isolation

White Paper

This ebook from Cytiva includes articles on optimizing nucleic acid isolation, avoiding bottlenecks in high-throughput NGS sample prep, isolating nucleic acids from clinical samples, moving from column to bead-based DNA isolation, and detecting mutations with liquid biopsies in cancer diagnostics.

Investigating Cell-Free DNA in Liquid Biopsy

White Paper

Liquid biopsy is a revolutionary approach that is opening previously unexpected opportunities in oncology. It empowers the detection and isolation of circulating tumor cells, cell-free DNA, and circulating tumor DNA, drawing on the strength of NGS technologies now available. Many difficulties have been overcome, but there is still no standardized approach for liquid biopsy processing and cell-free DNA analysis. Substantial progress has been made regarding sample preparation and isolation. However, continued progress in reducing genomic DNA contamination and PCR inhibitors is needed to further improve sensitivity.

This white paper from Cytiva discusses the challenges and opportunities in measuring the small amount of cell-free DNA in liquid samples for applications including oncology, organ and transplant medicine, and non-invasive prenatal testing.

Six Tips for Early-Stage MDx Companies Seeking Successful Commercialization

White Paper

This white paper from LGC Biosearch Technologies includes guidance for bringing a molecular diagnostic assay to market, including how to find a partner, ensure component quality, and budget for long-term success.

How to Choose a Molecular Diagnostics Supplier

White Paper

An important aspect of minimizing the time it takes to get a molecular diagnostics product to market is how product design and the critical components that make up the assay will scale for manufacturing.

This white paper from LGC Biosearch Technologies provides guidance for choosing an experienced supplier for molecular diagnostics components to avoid needing to trial new components in the late stages of product design, redesign an assay, or identify and onboard a new supplier during manufacturing.

Development of Patient-Derived Sex Chromosome Aneuploidy Reference Materials for NIPT

White Paper

Sex chromosome aneuploidies (SCAs) are genetic conditions caused by abnormalities in the number of X and Y sex chromosomes, which include 45, X (Turner syndrome), 47, XXY (Klinefelter syndrome), and 47, XYY (Jacobs syndrome). With a combined incidence of ~1 in 400 live births, SCAs occur more frequently than trisomy 21 (1:700). The majority of commercially available cell-free DNA (cfDNA) screens, also known as non-invasive prenatal tests (NIPT), can provide optional sex aneuploidy analysis.

Guidelines recommend the use of external run controls to validate test performance for SCAs when NIPTs are first implemented in a clinical lab and for routine performance monitoring. However, this can be problematic due to the rarity, low volume, and ethical considerations in obtaining clinical samples. This is especially important as current NIPT technologies have a lower sensitivity and positive predictive value for SCAs as compared to trisomy 21.

This poster from LGC SeraCare presents the development, characterization, and clinical performance of novel SNP-matched sex chromosome aneuploidy reference materials on several commercial NIPT assays.