Latest News

  • Top Stories from 2024: FDA Regulations, Babson Diagnostics, Thermo Fisher, CDx, More

    Diagnostics World | 2024 was a packed year for diagnostics, starting with the FDA’s final rule amending the agency’s regulations to clarify in vitro diagnostics (IVDs). Companion diagnostics (CDx) also made great strides. Plus: Babson Diagnostics has a new blood testing that does what Theranos claimed to do. Here are the top stories of Diagnostic World News and thoughts from industry leaders.

    Jan 3, 2025
  • PathAI Develops Algorithms for Breast Cancer Biomarkers, Smartphone App for Cardiopulmonary Assessment, More

    Diagnostics World | PathAI launches the AIM-IHC Breast Panel; electronRx plans purpleDx, a cardiopulmonary assessment app; and more.

    Dec 27, 2024
  • Follow the Money: First-in-Class ADCs for Underserved Cancers, Insulin Delivery System, More

    Diagnostics World | Adcendo plans to advance ADC programs; Beta Bionics to expand iLet Bionic Pancreas; and more.

    Dec 23, 2024
  • Circulating DNA Accurately Predicts for Prostate Cancer Prognosis

    Diagnostics World | Sepsis ImmunoScore, the first FDA-authorized AI diagnostic for sepsis, has high accuracy for the diagnosis of sepsis and for prediction of key adverse patient outcomes, reports a paper published last week in the New England Journal of Medicine AI. In the paper, the authors write that the test showed both diagnostic and prognostic power.

    Dec 17, 2024
  • Sepsis AI Tool Validated for Both Diagnostic, Prognostic Use

    Diagnostics World | Sepsis ImmunoScore, the first FDA-authorized AI diagnostic for sepsis, has high accuracy for the diagnosis of sepsis and for prediction of key adverse patient outcomes, reports a paper published last week in the New England Journal of Medicine AI. In the paper, the authors write that the test showed both diagnostic and prognostic power.

    Dec 12, 2024
  • Technology-Sharing Initiative Could Bring Multiplex PCR Testing Everywhere

    Diagnostics World | A trio of publicly traded powerhouse companies—South Korea-based molecular diagnostics company Seegene, artificial intelligence (AI) and cloud service provider Microsoft, and global research publisher Springer Nature—are collaborating on an ambitious technology-sharing initiative that aims to better prepare the world for the next pandemic.

    Dec 11, 2024
  • Breathalyzer Developers Target Array of Diseases and Conditions

    Diagnostics World | A number of research groups, companies, and collaboratives are pursuing breathalyzers aimed at tuberculosis, malaria, and other infectious diseases. Some of those same entities, and others, have also set their sights on applying breath-based technologies to a variety of other health concerns, including breast cancer, liver disease, gastrointestinal conditions, and lung disease.

    Dec 10, 2024
  • Researchers Accidentally Discover Genetic Signature for Early Detection of Sepsis in Newborns

    Diagnostics World | Researchers from Simon Fraser University in Burnaby, Canada, and the University of British Columbia in Vancouver, Canada, have discovered a genetic signature in newborn infants that can predict neonatal sepsis before symptoms show. Neonatal sepsis is difficult to diagnose because of the nonspecific clinical signs that are often considered typical behavior issues in newborns, such as difficulty feeding and irritability. Therefore, most infants are not diagnosed until they start developing or have acquired the disease.

    Dec 5, 2024
  • Noninvasive Malaria Test Looks for Parasites in Circulating Blood

    Diagnostics World | Most people in the United States have gotten no closer to malaria than the evening news, making the devasting nature of the infection in sub-Saharan Africa hard to fathom. Possibly once or more a day, people are being bitten by pathogen-carrying mosquitoes that cause untold hours of missed work and school and ultimately claim the lives of over half a million people—most of them young children.

    Dec 3, 2024
  • Follow the Money: Alimetry’s Wearable Gut Health Device, PrognomiQ Launches IVD, More

    Diagnostics World | Alimetry plans to commercialize its wearable gut health monitoring device; PrognomiQ launches in vitro diagnostic; and more.

    Nov 26, 2024
  • NOWDiagnostics OTC Syphilis Test Now Available, Detecting Alzheimer’s Earliest Stages, More

    Diagnostics World | NOWDiagnostics announced that its First To Know Syphilis Test, a key tool in syphilis prevention, is available for purchase nationwide; Veravas announced the results of an analytical verification study of its VeraBIND Tau assay, a next-generation test being co-developed with Phanes Biotech for the detection of Alzheimer’s disease at its earliest, most treatable stages; and more.

    Nov 25, 2024
  • Illumina Announces Update to TruSight Oncology Portfolio

    Diagnostics World | Illumina announced an expansion of its TruSight Oncology portfolio this week at the annual meeting of the Association of Molecular Pathology (AMP) in Vancouver, British Columbia, with TruSight Oncology 500 v2 planned for global release in mid-2025.

    Nov 21, 2024
  • Urine Liquid Biopsy Promises Easy Cancer Detection with miRNA, ML

    Diagnostics World | A team of researchers from Institute of Science Tokyo, Japan, are using nanowires with machine learning analysis to detect cancer-associated miRNAs in urine. Their research findings were published last month online in Analytical Chemistry.

    Nov 19, 2024
  • How to Advance Placental Pathology

    Diagnostics World | Placental pathology has potential to reveal critical insights into pregnancy complications, yet it remains underutilized in clinical trials. By incorporating placental evaluations into clinical research, doctors could better understand and treat conditions like preeclampsia and preterm birth, which are currently diagnosed based only on clinical signs.

    Nov 15, 2024
  • Promising Platform for the Pre-Symptomatic Detection of Parkinson’s Disease

    Diagnostics World | Researchers in Israel recently showcased a novel platform that can be used in the future for the early diagnosis of Parkinson’s disease (PD) by quantifying the distribution of alpha-synuclein (α-syn) in skin biopsies. A proof-of-concept study in humans, supported in part by the Michael J. Fox Foundation, suggests the single-molecule-level detection method might enable the disease to be detected up to 20 years before the first motor symptoms appear.

    Nov 13, 2024
  • Breath-Based Tools Look to Battle Deadly Infectious Diseases

    Diagnostics World | Recent years have seen progress toward developing tools that are designed to analyze a human breath sample to detect, diagnose, or monitor various health issues. Some of these efforts have focused on combating deadly infectious diseases, with intentions of creating cost-effective, easy-to-use breathalyzers capable of being deployed in rural, remote, and low-resource settings.

    Nov 12, 2024
  • Novel DELFI Approach Could Bring Space-Age Leaps in Cancer Detection

    Diagnostics World | A next-generation liquid biopsy approach combining cell-free DNA (cfDNA) “fragmentome” and protein biomarker analyses could aid in the early detection of ovarian cancer, suggests a recent study by researchers in the U.S., The Netherlands, and Denmark. The DELFI-Pro classifier was found to have a high positive predictive value, a key accuracy metric.

    Nov 7, 2024
  • New Diagnostic Tool Helps Identify When Antifibrotic Therapy in Breast Cancer Makes Sense

    Diagnostics World | A diagnostic test invented at the University of Arizona has demonstrated its potential to predict the likelihood of relapse or recurrence among patients with early-stage breast cancer and their response to antifibrotic therapy. The tool, known as MeCo Score, measures metastatic risk based on the acclimation of cancer cells to the mechanical stiffness of tissue (fibrosis) as computed from RNA sequencing data on tumor samples.

    Nov 4, 2024
  • The Case Against LDL and HDL Cholesterol Testing is Building

    Diagnostics World | In another few years, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) analytes may be “obsolete” because the famously bad and good guys in standard cholesterol tests provide less useful information about heart health than other lipid molecules circulating in the blood. The evidence emerges from a recent study in children and adolescents with overweight or obesity finding a new relationship between lipids and diseases impacting metabolism.

    Oct 31, 2024
  • Revvity In Vitro Diagnostic Assay, Novel Blood Pressure Monitor, Partnerships, More

    Diagnostics World | Revvity launches the in vitro diagnostic EURORealTime APOE assay in European countries that accept the CE mark; Withings Health Solutions announces a first-of-its-kind cellular blood pressure monitor; and more.

    Oct 30, 2024