• The Case for a ‘Payer-Lab Access Scorecard’

    Oct 06 | Bio-IT World | Diagnostic labs have an underappreciated opportunity to team up with health plans on pilot programs focused on improving access to testing and reducing health disparities. The laboratory community should be thinking beyond medical policy coverage to design for completion, measure and address the gaps, and share accountability for action, advises Mark Hiatt, M.D., chief medical officer for the accreditation organization RadSite. More

  • Follow the Money: Vaginal Microbiome Testing, Gene Sequencing, Computational Microscopy

    Oct 01 | Diagnostics World | Funding news from around the biotech space including investments in human tissue testing, oncology trial control data, AI protein design, more. More

  • WHO Lists Cepheid's Ebola Test, QIAGEN Receives FDA Clearance, ARPA-H Launches Autism Program

    Sep 30 | Diagnostics World | Oracle and the Buck Institute collaborate on aging research; Mayo Clinic's Precure selects Helix as its multi-omics lab; Revvity launches an IVDR-certified type 1 diabetes screening test; and more. More

  • CareDx Expands AI Diagnostic Ecosystem for Transplant Patients

    Sep 29 | Diagnostics World News | Since launching AlloSure Plus in July 2025, precision medicine company CareDx has been on a fast-moving expansion of AI-driven diagnostics aimed at one of medicine's highest-stakes patient populations: organ and bone marrow transplant recipients. More

  • Epigenetic Instability: Emerging Approach for Early Cancer Detection

    Sep 22 | Diagnostics World News | Epigenetic instability, a measure of the chaotic nature of methylation in specific regions of circulating cell-free DNA (cfDNA), has emerged as a promising new approach for early cancer detection. In a recent proof-of-principle study, the metric outperformed conventional absolute methylation signatures in detecting early-stage breast and lung cancers. More

  • Mayo Clinic, Thermo Fisher Scientific launch Precure, LLC

    Sep 16 | Diagnostics World News | This week Mayo Clinic announced the launch of Precure, LLC, with founding partner Thermo Fisher Scientific. Precure will create one of the world’s leading biomedical datasets by integrating proteomic, genomic, and longitudinal clinical data to help researchers identify early biological signals of disease and provide a foundation for new discoveries in disease biology, diagnostics and therapeutics. More

  • 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
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