Rapid testing for syphilis and the practice of same-visit ‘test and presumptively treat’ for patients in the United States have received recent federal- and state-level support.

Rapid treponemal tests are suitable for both initial screening and confirmatory testing in traditional and reverse syphilis algorithms. Clinics and labs may choose rapid treponemal screening first — i.e., the reverse algorithm — because primary infection can be detected at an earlier stage than with nontreponemal tests (RPR) and with fewer false positives.

In this white paper from OraSure Technologies, Jeffrey Klausner, professor of medicine and public health at the Keck School of Medicine at the University of Southern California, describes how rapid treponemal testing offers highly accurate results in just 10 minutes, and how people who test positive can get antibiotic treatment immediately.

Mark Lewis is a well-known GI oncologist at Intermountain Health in Salt Lake City, Utah. Gifted with a passionate communication style, he has over 93,000 followers on X. Next month, he will live-tweet his upcoming colonoscopy.  

In this episode, Lewis joins Theral Timpson in an ongoing series on minimal residual disease (MRD) testing, a revolutionary blood test that is helping detect residual cancer, causing a paradigm shift in patient management. He says MRD testing has transformed his own practice and describes how this “liquid biopsy” approach, previously common in hematology, is also advancing the detection of solid tumors.

“News flash,” he says in today’s show, “we were trained a certain way. My training ended 12 years ago, and I had fantastic training. I did my fellowship at the Mayo Clinic. But if I practiced now the way I was trained then, my patients would be so underserved, almost to the point of malpractice.”  

Lewis considers MRD testing a key part of his own standard of care and anticipates its broader adoption among GI oncologists. He also highlights the recent findings from the GALAXY study, which show improved survival rates for patients utilizing MRD testing, underscoring its potential to reshape GI oncology practices in the near future.

Featured Guest:

Mark Lewis, MD

Director of Gastrointestinal Oncology

Intermountain Healthcare

NeoGenomics is a large research and reference laboratory located in California and has experienced significant increases in annual slide volumes. The NeoGenomics senior management team was tasked with evaluating ways to scale up digital pathology operations to keep up with increasing demand.

This white paper from Leica Biosystems reports on a study in which NeoGenomics Laboratories compared the performance of the Aperio GT 450 and Aperio AT2 digital pathology slide scanners, measuring throughput, QC tech time, and other performance metrics.

Targeted therapies have expanded treatment options for diseases like non-small cell lung cancer. While NGS-based tumor profiling can detect multiple targetable alterations from limited tissue, many settings employ only single-variant and single-gene analysis. Improved detection of amplifications and gene rearrangements can provide more complete tumor characterization to identify all possible therapies.

This white paper from Labcorp presents data showing that comprehensive genomic profiling with PGDx elio tissue complete demonstrates high concordance with conventional diagnostic approaches for ALK gene rearrangements and provides greater insight into the underlying genomic events and genomic co-alterations that may impact clinical outcomes.

In biomarker discovery, it is critical to be able to evaluate a wide range of proteins. The more proteins that can be reliably measured, the better the chance that biomarker discovery and validation will be successful and that nothing will be missed.

This white paper from SomaLogic presents data showing how the SomaScan Platform — a highly multiplexed, sensitive, quantitative, and reproducible proteomic tool for discovering previously unidentified biomarkers — maintains precision and consistency at low and high assay sizes.

The SomaScan Platform is a highly multiplexed, sensitive, quantitative, and reproducible proteomic tool for discovering previously unidentified biomarkers for drug discovery, pre-clinical and clinical drug development, and clinical diagnostics across a range of diseases and conditions.

This technical note from SomaLogic provides background on the SomaScan platform, as well as performance metrics for the SomaScan 11K Assay v5.0.

Chronic kidney disease (CKD) affects millions worldwide and is a leading cause of morbidity and mortality. Early detection of fibrotic processes is crucial for developing therapeutic strategies to mitigate kidney function loss. FibroKey is a non-invasive, mass spectrometry-based multiplex assay designed to monitor fibrosis-related biomarkers. FibroKey enables pharmaceutical companies to track disease progression and therapeutic effects in urine samples, providing valuable insights into fibrosis pathways and CKD progression.

This white paper from Inoviv reports on a study that found that quantification of biomarkers with FibroKey enabled better staging of CKD, supporting therapeutic decisions and drug development efforts, allowing researchers to track disease progression with high accuracy, which is essential for assessing therapeutic efficacy and conducting clinical trials.

Launching a quantitative PCR (qPCR) experiment requires a deep understanding of complex principles, protocols, and methodologies. Parsing through the massive amounts of published qPCR data to select the best experimental framework requires a significant amount of time, expertise, and resources.

This white paper from LGC Biosearch Technologies discusses how to improve qPCR assays with specific considerations for assay optimization and validation based on the practical application of the Minimum Information for Publication of Quantitative Real-Time (RT) PCR Experiments (MIQE) guidelines.

In late 2022 Turkey’s minister of health, Fahrettin Koca, announced government plans for an HPV vaccination program geared at achieving the WHO target 90 percent vaccination rate of the targeted population by 2030. This program included increasing HPV screening access and the development of a custom HPV diagnostic test. The challenge was to create an assay that was accurate, robust, and specific to the 16 strains of interest in as few reactions as possible per patient sample.

This white paper from LGC Biosearch Technologies describes how companies working to develop screening tests as part of the Turkish government’s HPV vaccination initiative partnered with Biosearch’s PCR assay design and development team for support in choosing the right markers and technology for the probes.

In this guide from LGC Biosearch Technologies, scientists share tips for getting reliable, consistent data from qPCR assays for pathogen detection.

The guide describes how to maintain sample integrity, prepare for a high-throughput workflow, apply good laboratory practices, and more.

Science, particularly in regulated fields such as molecular diagnostics and forensics, is advanced through dedication to stringent processes and methods. Problems such as high background, low sensitivity, and low specificity can be avoided through stringent adherence to carefully developed optimization and validation processes.

This white paper from LGC Biosearch Technologies discusses how to design and implement controls, validate assays, and find sources of PCR contamination to mitigate problems in molecular diagnostics.

Large-scale SARS-CoV-2 testing initiatives that have been set up across the world have underscored the need for a high degree of automation and dependable supply chains across the sample-to-result workflow. Because of unprecedented volumes in both screening and diagnostics, efficiencies across sample accessioning and preparation, extraction, PCR cycling, data analysis, and reporting have become instrumental in providing the required throughput capacity and maintaining the accuracy and reliability required for clinical diagnostics. As respiratory illness seasons come and go, the need for broader panels to screen for COVID-19 and other respiratory infections like influenza will increasingly pressure labs to have set-ups that can adapt to multiplexing while maintaining a throughput that keeps up with demand.

This application note from LGC Biosearch Technologies discusses the high-throughput capability of the SARS-CoV-2 Real-Time and End-Point RT-PCR Test and the advantages of the automation that is further enabled by including UgenTec’s FastFinder software into the testing workflow.

Microfluidics is the manipulation of small volumes of fluids (nanoliters or less) within networks of channels that are tens to hundreds of microns in diameter. Microfluidic instruments have low sample and reagent volume requirements and short analysis times and can facilitate the type of miniaturization that has led to the rise of lab-on-a-chip technologies. Microfluidic platforms are used across a broad range of application areas including pharmacogenomics, sample identification, and agricultural genomics, and are revolutionizing the way research in these areas is carried out.

This ebook from Standard BioTools includes five articles discussing the benefits of microfluidics-based PCR in enabling precision medicine, automating lab activities, singleplexing versus multiplexing, considerations for cost-effective analysis in genomics-driven fields, and challenges and perspectives in evaluating immune function and mechanisms of cell differentiation.

Bringing a novel life sciences or diagnostics instrument to market can be a lengthy and costly undertaking. It requires years of planning and execution, and comes with varying levels of risk, depending on the nature of the instrument and likelihood of acceptance by the target market. When creating a new system, designers understandably focus much of their energy on initial concept development and reducing the associated expenses, with less thought into capturing the cost of an instrument over its lifetime. With most devices expected to be operational for 10 years or more, it’s vital to think beyond the initial investment, factoring in the operational costs that impact the financials of both instrument developers and end-users for years to come.

This white paper from Tecan discusses the importance of considering the total cost of ownership (TCO) in the development, manufacturing, and maintenance of life sciences and diagnostics instruments to ensure long-term financial sustainability and maximize return on investment.

With the rise of precision oncology therapies — particularly those that target specific variants or remain effective despite specific mutations — there is more need than ever for routine, highly sensitive monitoring of the cancer mutations that arise during a patient’s treatment journey. In some cases, mutations are indicative of the onset of resistance to treatment; detecting them early enables a shift to a different therapy to stay ahead of the cancer.

Unfortunately, most available tests lack the sensitivity required to detect these critical mutations. Consider the challenges in picking up that tiny signal: it may be just one new mutation, potentially coming from one of many tumors or just one part of a tumor. Ideally, routine testing should be noninvasive, meaning this weak signal has to be identified from a simple blood sample amid overwhelming amounts of genetic material from sources other than the tumor. Standard liquid biopsy tests that use cell-free DNA (cfDNA) or circulating tumor DNA (ctDNA) are not sensitive enough to detect these important mutations reliably.

This white paper from Asuragen details evidence that querying exosomal RNA in addition to cfDNA can boost sensitivity for routine monitoring of cancer mutations, offering physicians and their patients a more effective strategy for early detection of key variants, empowering them to make more informed treatment decisions along the way.