• Grail Making Major Strides Toward Population-Scale Cancer Control

    Sep 12 | Diagnostics World | Multi-cancer early detection (MCED) technology is going to be the best way to achieve population-scale cancer control, and Grail hopes its Galleri blood test that screens for more than 50 types of cancer is among the first to be approved by the U.S. Food and Drug Administration (FDA). More

  • AI Predicts Diseases by Reading Tongue Complexion

    Sep 10 | Diagnostics World | A team of Iraqi and Australian researchers from Middle Technical University (MTU) in Baghdad, Iraq, and the University of South Australia (UniSA) collaborated to develop an AI model that can predict diseases based on the color of the patient’s tongue. More

  • ‘Sparse’ Proteomic Signatures Can Foretell Risk of 60-Plus Diseases

    Sep 05 | Diagnostics World | It now appears possible to develop a series of blood-based tests looking for the “sparse” protein signatures of 67 pathologically diverse diseases, which would enable the early detection of high-risk individuals in primary care settings who could then be closely monitored for development of those conditions. More

  • Proscia Releases Real World Diagnostics Datasets

    Sep 04 | Diagnostics World | Today, Proscia announced a real-world data offering on its Concentriq platform comprising a diverse repository of over 10 million whole slide images enhanced with structured data from molecular tests, pathology reports, laboratory tests, and next-generation sequencing across therapeutic areas. More

  • FDA: Cybersecurity Could be Big Headache For Medical Device Developers

    Sep 03 | Diagnostics World | Courtney Lias, Ph.D., the newly named director of the FDA’s Office of In Vitro Diagnostic Devices (OHT7) took to the stage at last week’s Next Generation Dx Summit to discuss the latest trends, and associated challenges, in carrying out total product lifecycle activities for in vitro diagnostic devices for the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). More

  • Follow the Money: Addressing Unmet Oncology, Autoimmunity Needs, Detecting Cancer Risk, More

    Aug 29 | Diagnostics World | Third Arc Bio plans to use their funding to address unmet needs in oncology and autoimmunity; Foresight Diagnostics plans to accelerate the clinical development and commercialization of their cancer recurrence testing platform, PhasED-Seq, which leverages the sequencing of phased variants for ultrasensitive and highly specific detection of circulating tumor DNA (ctDNA); and more. More

  • Roche Acquires LumiraDx’s Technology, First OTC Syphilis Test, Faster Diagnosis For U.S. Military, More

    Aug 28 | Diagnostics World | Roche announced the completion of the acquisition of LumiraDx’s Point of Care technology; NOWDiagnostics announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization to its First To Know Syphilis Test for OTC use; MAUI Imaging emerged from stealth with the announcement of a $4 million U.S. Department of Defense (U.S. Army Medical Research and Development Command) contract to support trauma medicine across four branches of the military seeking to enable faster diagnosis and interventional care; and more. More

  • The Great Debate: FDA Final Rule on Laboratory-Developed Tests

    Aug 26 | Diagnostics World | A final rule on laboratory-developed tests (LDTs) released by the U.S. Food and Drug Administration (FDA) in early May has done little to settle the longstanding debate about how LDTs ought to be regulated. The rule clarifies that in vitro diagnostic products (IVDs) are medical devices under the Federal Food, Drug, and Cosmetic Act, even when the manufacturer is a laboratory, and establishes a framework for FDA oversight of LDTs inclusive of a policy to phase out the agency's "enforcement discretion" policy. More

  • Solving the Challenges of Comprehensive Carrier Screening by Long-Read Sequencing

    Aug 23 | Diagnostics World | For clinical laboratories, keeping up with the changing landscape of carrier screening has been quite challenging lately. A maze of ancestry-based screening guidelines has been replaced with new guidelines that call for screening an order of magnitude of more genes. More

  • Babson Diagnostics’ Makes Consumer-Initiated, Small-Volume Blood Testing Reality

    Aug 21 | Diagnostics World | Theranos comparisons are generally not favorable, but Babson Diagnostics has now rolled out blood testing that achieves what Theranos claimed to: needle-free, small-volume blood testing, from the convenience of retail pharmacies. More
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