Latest News

  • Self-Testing: ‘With Crisis Comes Opportunity’

    Diagnostics World News | The COVID-19 pandemic is ushering in an era of self-testing that has been at least a decade in the making. Despite the evidence, it took a public health crisis to finally convince most clinicians that the benefits of self-swabbing with an at-home test kit outweigh any of the potential problems. Before long, multiple studies emerged showing patients did just as well as clinicians with rapid self-testing whether observed or unobserved.

    Jul 21, 2022
  • Nanopore-Based DNA Computing Detects Cancer at Subfemtomolar Concentrations

    Diagnostics World News | Bile duct cancer is a complex and rapidly progressing disease often deemed terminal at the time of diagnosis. However, a research team at the Tokyo University of Agriculture and Technology discovered nanopore-based DNA computing technology as a means of early cancer detection and improved patient outcomes.

    Jul 20, 2022
  • Evolving Regulatory Landscape For Companion Diagnostics

    Diagnostics World News | It is now the expectation if not the reality that companion diagnostics (CDx) be approved concurrently with their corresponding therapeutic product. Multiple countries are quickly adopting policies and regulations for drug-diagnostic co-development and common themes are emerging about how a CDx should be clinically validated. At the upcoming Next Generation Dx Summit, speakers will explore the evolving global regulatory landscape for diagnostics and the impacts on co-development programs, as well as strategies for navigating the changing environment.

    Jul 19, 2022
  • Consumers Have A Love-Hate Relationship With Smart Gadgets

    Diagnostics World News | Consumers frequently express a mixed bag of sentiments about fitness wearables and body-monitoring devices flooding the market. Diagnostics World News recently surveyed a handful of users of wearables and body-monitoring devices to get firsthand feedback on the data, the user experience, and their concerns.

    Jul 14, 2022
  • Blood Biomarker Could Help Predict Severe Crohn’s Disease, Enable Early Intervention

    Diagnostics World News | An international group of researchers has shown that a biomarker may help predict complicated Crohn’s disease and can be detected long before diagnosis.

    Jul 12, 2022
  • Novel ct-DNA Blood Test Safely Spares Colon Cancer Patients from Chemotherapy

    Diagnostics World News | Australian-American researchers showcase a new ct-DNA diagnostic blood test that reduces the need for adjuvant chemotherapy without increasing colon cancer recurrence rates.

    Jul 7, 2022
  • DNA Methylation Making Its Mark In Early Cancer Detection

    Diagnostics World News | The current status in the development of DNA methylation biomarkers is a topic of several liquid biopsy talks at the upcoming Next Generation Dx Summit.

    Jul 6, 2022
  • A Look Ahead at Pan-Cancer Testing: Big Unknowns, Great Debates, and Key Questions Facing the Future of the Field

    Diagnostics World News | In recent months, Diagnostics World has explored the realm of pan-cancer testing.  As research and development continue in efforts to build upon the progress made so far, there’s still plenty to be sorted out. Here we dig a bit deeper into some of the biggest lingering issues facing the future of this fledgling field.

    Jul 5, 2022
  • NGS Solution Detects Aneuploidies, AI-Powered Biomarker Test for Urothelial Cancer, More

    Diagnostics World News | A blood test detects T cells activated by Borrelia burgdorferi, the bacterium that causes Lyme disease; a new artificial intelligence model accurately identifies patients at increased risk of undiagnosed structural heart disease; newborn screening for sickle cell disease expands in sub-Saharan Africa; a new melanoma test accurately assesses and classifies advanced melanoma patients as likely or unlikely to benefit from immune checkpoint inhibitor therapies; and more.

    Jun 30, 2022
  • Follow the Money: Multi-Analyte Breast Cancer Testing, Metabolism-Based Liquid Biopsy, More

    Diagnostics World News | Funding for precision immunology pipeline, AI melanoma detection, multi-cancer early detection, and more.

    Jun 29, 2022
  • Illumina Launches Homologous Recombination Deficiency Genetic Test

    Diagnostics World News | Last week Illumina launched a research test, codeveloped with Merck, that builds upon Illumina's commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology. The test adds assessment of a new genomic signature to the distributed, market leading TruSight Oncology 500 assay.

    Jun 27, 2022
  • Designer Magnetic Molecular Probes Show Diagnostic Promise as Chemical Thermometers

    Diagnostics World News | A Colorado State University team has designed metal ion-containing molecules that–alongside magnetic resonance imaging–could detect slight shifts in the human internal environment.

    Jun 23, 2022
  • Oxford Nanopore’s Metagenomics Workflow Characterizes DNA, RNA Viruses

    Diagnostics World News | A team of researchers from Guy's and St Thomas' NHS Foundation Trust and Oxford Nanopore have shared a novel protocol for the rapid metagenomic characterization of DNA and RNA viruses. The workflow identified pathogens in a matter of hours.

    Jun 22, 2022
  • Navigating The Emergency Use Authorization Process for Diagnostics

    Diagnostics World News | The pandemic has thrown a spotlight on the Emergency Use Authorization (EUA) process of the U.S. Food and Drug Administration (FDA) whereby the agency can quickly give companies temporary permission to market unapproved medical products or unapproved uses of approved ones. The FDA’s EUA power has been in place a long time, and many such authorizations—including diagnostics specific to the Ebola and Zika viruses—remain open many years after declaration of the public health emergency that invoked it, according to B. Melina Cimler, Ph.D., CEO and founder of PandiaDx, a consultancy specializing in regulatory matters surrounding in vitro diagnostics.

    Jun 21, 2022
  • 100K Synthetic Brain Images Now Available to Aid Diagnostics, Modeling Disease Progression

    Diagnostics World News | Jorge Cardoso, a researcher at King’s College London and CTO at the London AI Centre, and NVIDIA have released 100,000 synthetic brain MRI images freely available to healthcare researchers. They believe the dataset will accelerate diagnosis and understanding of dementia, aging, or any sort of brain disease.

    Jun 16, 2022
  • ‘Federated Analysis’ Helps Fill Genetic Risk Knowledge Gap On BRCA Genes

    Diagnostics World News | A significantly heightened risk of breast cancer has two well-known culprits—mutations to the tumor suppressor genes BRCA1 and BRCA2—but more than 40% of the time they are black-box “variants of uncertain significance.” Using a new data-sharing innovation known as federated analysis, however, an international team of researchers has categorized 16 of these uncertain variants as benign or likely benign so their carriers may be able to have their clinical risk of disease managed properly and avoid the risk of invasive and irrevocable surgeries.

    Jun 14, 2022
  • New Technology Can Localize Epileptic Seizures In Minutes

    Diagnostics World News | Novel network analysis technology that uses only 10 minutes of resting state electrophysiological recordings has been shown to localize seizure onset brain regions and predict seizure outcomes in epilepsy patients.

    Jun 8, 2022
  • The Role of AI in Precision Health Explored at Bio-IT World Conference

    Diagnostics World News | At the Bio-IT World Conference & Expo last month, several sessions explored ways AI is transforming oncology diagnosis, research, and care delivery. Speakers from the National Cancer Institute, Tempus Labs, The Ohio State University, IQVIA, Pangaea Data, University of Illinois Cancer Center, Stable Solutions and more discussed how far we’ve come, and where our next challenges lie.

    Jun 7, 2022
  • FDA Now Accepting Non-COVID Pre-Submissions for IVD Tests

    Diagnostics World News | The U.S. Food and Drug Administration’s Center for Devices and Radiological Health this week announced that it will start accepting all non-COVID in vitro diagnostic pre-submissions starting June 1, 2022.

    Jun 3, 2022
  • Guardant and IQVIA Develop Precision Oncology Platform to Normalize Clinical Data

    Diagnostics World News | Innovative Practices Award | Extracting high-quality data from clinical records can be time-consuming and costly, primarily when manual abstractors are tasked with mining complex, unstructured, and lengthy documents. That’s why the scientists at Guardant Health and Linguamatics, an IQVIA company, launched a real-world evidence database called GuardantINFORM. The platform was named one of the 2022 Bio-IT World Innovative Practices award winners.

    Jun 2, 2022