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Diagnostics World | A much-anticipated rule to regulate laboratory developed tests (LDTs) as medical devices has arrived, with significant implications for the diagnostic industry and patient care. Here’s a closer look at the historical context underlying the new rule, the debate leading up to this moment, recent updates, and the road ahead.
May 2, 2024
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Diagnostics World | Significant evidence now exists implicating the Epstein-Barr virus (EBV) as a causal factor in the development of multiple sclerosis (MS), making treatment of the virus a priority. To that end, research scientists at Trinity College Dublin have developed a blood test to measure the immune response to EBV that could be used as an outcome measure in future clinical trials in people with established MS.
May 1, 2024
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Diagnostics World | Researchers at the University of Chicago have succeeded in creating a digital twin of the gut microbiome of premature infants that reliably models the many interactions taking place between quickly changing bacterial inhabitants. The so-called “Q-net” model, created with generative artificial intelligence (AI), was used to make predictions about which infants were going to have neurodevelopmental deficits using head circumference as the proxy.
Apr 30, 2024
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Diagnostics World | Roche will distribute Prenosis’s Sepsis ImmunoScore, an artificial intelligence/machine learning software as a medical device to guide rapid diagnosis of sepsis and prediction of adverse outcomes; PathAI announced a strategic partnership with Google Cloud at Bio-IT World Conference & Expo to help biopharma companies and anatomic pathology labs accelerate the adoption of AI and digital pathology; more.
Apr 25, 2024
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Diagnostics World | Asher Therapeutics will advance the clinical development of its lead program, AB248, a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody; Kryptos Biotechnologies will further develop Kryptos’s flagship point-of-care molecular diagnostics system Kuick and advance the clinical study of the respiratory combo tests; DeepCure plans to advance its generative AI and physics-based engine to innovate the discovery of small molecule therapies for challenging targets; more.
Apr 24, 2024
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Diagnostics World | Researchers in Denmark have devised a blood-based diagnostic technique that can detect even trace amounts of an aggregated protein indicative of Alzheimer’s disease before any disease-related changes show up on a PET scan, one of the traditional testing methods. The same technology can be used for developing new therapies by revealing what part of the innate immune system is engaged in the fight.
Apr 18, 2024
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Diagnostics World | Minimal residual disease testing (MRD) has been gaining ground in diagnostics, and a panel took on the topic at the Precision Medicine TriCon late last month.
Apr 17, 2024