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Diagnostics World | For diagnostic labs, 2025 is a “big, complicated year” that began with a milestone “win” for laboratories when a U.S. District Court decision vacated a Food and Drug Administration (FDA) final rule that would have regulated all laboratory-developed tests (LDTs) as medical devices. Despite that win, there is no shortage of concerns and challenges facing the industry, including unknowns about the final shape of the federal reconciliation package on Capitol Hill.
May 13, 2025
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Diagnostics World | The stethoscope, despite being more than 200 years old, is not an easily retired diagnostic device. It remains symbolic of the medical profession, even if many physicians no longer wear them and those that do are not particularly good at using them.
May 8, 2025
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Diagnostics World | Cleveland Diagnostics announced the results of a new independent study published in Urology; Illumina and Tempus AI collaborate to accelerate clinical adoption of next-generation sequencing tests through novel evidence generation; LinusBio announced a new partnership with the BRAIN Foundation to support advancing autism biomarker research and facilitating early identification and intervention of autism spectrum disorder; and more.
May 6, 2025
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Diagnostics World | One of the most important tools we have to reduce mortality from cancer is early detection. Mammograms have had a significant impact in improving outcomes for patients with breast cancer, and colonoscopies have done the same for patients with colorectal cancer. But despite broad recognition of the importance of early cancer detection, our ability to screen for a wide range of cancers is quite limited. In fact, there are only five cancers for which Medicare is directed to pay for screening: breast, cervical, colon, lung, and prostate.
May 2, 2025
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Diagnostics World | Cleveland Diagnostics announced the results of a new independent study published in Urology; Illumina and Tempus AI collaborate to accelerate clinical adoption of next-generation sequencing tests through novel evidence generation; LinusBio announced a new partnership with the BRAIN Foundation to support advancing autism biomarker research and facilitating early identification and intervention of autism spectrum disorder; and more.
Apr 30, 2025
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Diagnostics World | Atsena will advance their lead program, ATSN-201, for the treatment of a genetic condition that is typically diagnosed in childhood and leads to blindness later in life; Merida Biosciences plan to develop antibody-like therapeutics to help treat multiple diseases; and more.
Apr 29, 2025
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Diagnostics World | Over the past few years, a multidisciplinary team of experts has been spreading the news that an abnormality of the heart’s left atrium (LA), known as LA myopathy, can be a marker of elevated risk of stroke and dementia—even in the absence of atrial fibrillation (AFib). The current “gap in the field” is that there is no established way to characterize the condition.
Apr 24, 2025