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White Papers and Videos

Lex Diagnostics and the RapiDxFire Lyo-Flex 1-Step RT-qPCR 5X Master Mix

White Paper

This white paper from LGC Biosearch Technologies discusses PCR-based point-of-care testing and presents a case study in which Lex Diagnostics, a UK-based diagnostics company, partnered with Biosearch to develop a customized RT-PCR master mix suitable for the demands of point-of-care PCR testing.

Leveraging Precision Medicine to Improve Patient Care

White Paper

Technology has advanced to allow for efficient testing of an individual’s genetics relative to treatment response. Application of pharmacogenomics (PGx) testing across therapeutic areas can lead to more optimized drug therapy, increasing efficacy while decreasing or avoiding adverse drug reactions in patients. The positive impact of PGx on costs is realized at the patient and system levels, supporting broader implementation of PGx services.

This white paper from LetsGetChecked discusses PGx testing, why and when it should be performed, disease areas that could benefit from PGx testing, evidence supporting testing, and cost savings afforded by PGx.

Digging Deeper into OncoSpan’s NGS Data

White Paper

This application note from Horizon Discovery describes the types of data included in the high-coverage batch-specific in silico NGS data sets that accompany OncoSpan oncology reference standards as well as how the data are generated and validated.

Developing a High-Coverage, Pan-Cancer NGS Reference Material for Assay Validation

White Paper

Comprehensive genetic testing using large gene NGS panels is used commonly in the detection of somatic variants in cancer genetic analysis. Errors introduced during each step of the workflow can limit the interpretation of results.

This poster from Horizon Discovery describes the development of a family of oncology reference materials made to closely mimic patient samples, validate end-to-end processes from extraction to analysis, and determine limit of detection in order to ensure the reliability of NGS workflows and mitigate internal biases.

Pan-Cancer Six-Fusion Panel FFPE RNA (HD834) Reference Standard

White Paper

This application note from Horizon Discovery describes the importance of novel kinase fusion detection across cancer types, the challenges of detecting fusions with FISH and targeted RT-qPCR, the advantages of RNA profiling, and Horizon’s FFPE control material, containing 6 clinically relevant, cell-line derived, kinase-fusion RNA biomarkers.

Horizon Shines in Extensive FINH Study Identifying Validated Quality Control Materials as Vital Components of ctDNA Assay Workflows

White Paper

This white paper from Horizon Discovery summarizes the findings of a Foundation for the National Institutes of Health study investigating the performance of quality control materials (QCMs) in circulating tumor DNA (ctDNA) assays, demonstrating how a laboratory’s ctDNA assay workflow can be affected by the source of their QCMs.

Real-World PD-L1 Testing Data Provides Insight into the Evolving Immuno-oncology Landscape

White Paper

This white paper from NeoGenomics presents results from an analysis of real-world data investigating the trends in immunotherapy use, revealing insights as to the most commonly ordered biomarker tests, the complex companion diagnostics landscape, and patient outcomes.

Taking the Headache out of Variable Demand with Scalable Solutions

White Paper

This case study describes how Eppendorf worked with a market leader in laboratory automation who needed an original equipment manufacturer who was able to produce a broad portfolio of automation tips for a modular laboratory automation solution.

The customer needed pipette tips to meet extremely high requirements for precision and accuracy, offer reliable protection against aerosol contamination and high purity levels, and be suitable for use with different pipetting volumes. They also needed to be able to customize these tips to meet the needs of the global research and regulated in vitro diagnostic market.

But their biggest challenge was that fluctuating product demand, caused by the COVID-19 pandemic, meant they were unable to predict the volume of these critical components they would need.

This case study outlines the steps that Eppendorf OEM took to co-create a flexible production solution that was mutually beneficial to both parties.

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.

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.