Latest News

  • 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
  • AI-Powered Pathology Reshapes Diagnostics and Precision Oncology

    Diagnostics World News | Crosscope and Farcast Bioscience created OrionAI–an artificially intelligent (AI) diagnostic assistant for tumor histological examination. Crosscope developed the AI-enabled digital pathology platform and proprietary algorithms, while Farscape Bioscience created the histoculture platform that preserves entire human tumor microenvironments. OrionAI increases diagnostic speed and lowers misdiagnosis rates of head and neck squamous cell carcinoma, a highly prevalent disease worldwide.

    May 31, 2022
  • Illumina Gets Companion Diagnostic Indication in EU for Pan-Cancer Test

    Diagnostics World | This week Illumina announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer.

    May 27, 2022
  • $10M Lyme Disease Dx Prize, Ultrarapid WGS from PerkinElmer, More

    Diagnostics World News | An AI-based diagnostic histoculture platform preserves human tumor microenvironment; FUJIFILM partners with over 150 imaging centers across the United States; two multiplex respiratory virus tests enable rapid differentiation and detection; and more.

    May 26, 2022
  • Follow the Money: Parkinson’s Screening, Lung Disease Early Detection, More

    Diagnostics World News| Funding for pathology diagnostics, rapid DNA sequencing, AI-powered disease detection, and more.

    May 25, 2022
  • Point-Of-Care Skin Cancer Imaging Device Moving Into Large-Scale Clinical Trials

    Diagnostics World News | Electrical and computer engineers at Stevens Institute of Technology, together with clinical dermatology specialists at Hackensack University Medical Center (HUMC), are collaboratively developing a low-cost, handheld imaging device that provides laboratory-grade diagnoses of different types of skin cancer. It should be received as a welcome alternative to skin biopsies, about half of which are unnecessarily done for want of another method for differentiating benign from cancerous tissue.

    May 19, 2022
  • New Cloud-Native Database Offers Rapid Diagnosis of Rare Childhood Genetic Disease

    Diagnostics World News | Stephen Kingsmore, Rady Children’s Institute for Genomic Medicine, and Stavros Papadopoulos, TileDB, presented at Bio-IT World Conference & Expo about diagnostic whole-genome testing, newborn screening, treatment integration, and a single-platform multi-dimensional database.

    May 18, 2022
  • Microchip With At-Home Diagnostic Potential

    Diagnostics World News| A first-of-its-kind microfluidic diagnostic device that eliminates the usual liquid handling steps could enable pathogen detection, as well as gene sequencing, outside of a lab setting involving a lot of equipment and personnel. The small, no-frills chip is being developed by electrical and computer engineers at the University of Minnesota Twin Cities.

    May 17, 2022