• In Diagnostic Development, a Partnership Model Can Bridge the Gap Between RUO and IVD

    Sep 16 | Diagnostics World | Since last year’s landmark legal ruling that the U.S. Food and Drug Administration’s attempted oversight of laboratory-developed tests was not supported by current legislation, the research-use-only (RUO) pathway has emerged as an increasingly attractive alternative to the FDA-regulated in vitro diagnostic (IVD) route for diagnostic companies. There’s nothing wrong with that, provided that analytical rigor and performance are not compromised throughout the development and validation processes. More

  • Early Detection Could Expand the Benefits of New Pancreatic Cancer Drugs

    Sep 11 | Diagnostics World | As one of the highest-mortality cancers, pancreatic cancer has long been seen as a death sentence. But just in the past year we have witnessed exciting new study results bringing new hope. We can imagine adding years of productive life, or even curing disease completely. There is a way to achieve this, and it’s through early detection. More

  • LinusBio Expands From Disease Testing Into Consumer Exposure Monitoring With Traced

    Sep 08 | Diagnostics World | LinusBio, the company behind the hair-based autism test ClearStrand-ASD, is applying the same underlying technology to a new consumer product called Traced — a test that tracks a person's exposure to metals and other elements over roughly a month, rather than capturing a single snapshot in time. More

  • Epigenetic Clocks Get a Transcriptional Boost

    Sep 03 | Diagnostics World | Epigenetic methylation markers on your DNA can be used to predict your biological age, how soon you’ll die, or the development of various age-related diseases and morbidities. Researchers at the University of Southern California have extended these tests by looking at all of the gene transcription taking place as a function of each of five different popular clock predictors, increasing our understanding of the mechanisms. More

  • Reengineering Pathology Bot by Bot

    Sep 02 | Diagnostics World | Artificial intelligence can help reengineer pathology toward the point of care and provide guidance to first-on-the-scene responders, including those in military battlefields with no internet connectivity and limited medical training. The technological possibilities are driven largely by the data foundation that AI models learn from and analyze as well as institutions finding the “Goldilocks” speed at which to move on adoption that is neither reckless nor paralyzed by fear. More

  • AI Helps Find ‘Hidden Gems’ Buried in Sleep Study Data

    Sep 01 | Diagnostics World | For decades now, doctors have been referring people suspected of having obstructive sleep apnea to a specialized medical facility for a polysomnogram (PSG). The gold-standard overnight test collects millions of data points from across the body, only a small subset of which gets prioritized for scoring the severity of the condition—notably, the apnea-hypopnea index (AHI) ranking how often their breathing slows or stops per hour of sleep. More

  • Follow the Money: Rare Kidney Disease, Limbal Stem Cell Deficiency, Biological Foundation Models

    Aug 26 | Diagnostics World | Bios Life develops a predictive platform for cancer screening and surveillance; Dash Bio advances automated bioanalysis workflows; Bridge to Life expands its organ preservation technology for transplantation; and more. More

  • Seegene’s PCR-based Test for STIs, HPV, National Health Council Launches Latest Campaign, QIAGEN Receives FDA Clearance

    Aug 25 | Diagnostics World | HanchorBio and the research team led by Professor Sung-Liang Yu of National Taiwan University enter collaboration; NORD adds three new centers to its Rare Disease Centers of Excellence Network; NeuraLight announces that its platform will be deployed as part of the Healthy Brain Ageing study; and more. More

  • Immune Biomarkers May Help Guide Psychedelic Treatments for Cancer-Related Depression

    Aug 21 | Diagnostics World | Researchers at The University of Texas MD Anderson Cancer Center are investigating whether immune-system biomarkers could help identify cancer patients most likely to benefit from rapid-acting psychedelic treatments for depression. Researchers examined whether these rapid-acting antidepressants share biological pathways that could serve as biomarkers for future treatment strategies. More

  • New Long-Read Sequencing Tool Targets Difficult-to-Detect Cancer Mutations

    Aug 20 | Diagnostics World | Analyzing genetic changes in cancer cells provides insight into how tumors develop and help with developing treatment through precision oncology. Long-read sequencing can help, but there is still a higher error rate compared to short-read sequencing. Researchers at The University of Hong Kong addressed this gap with ClairS, a tool designed to identify small cancer-related genetic mutations. More
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