• Protecting Clinical Labs in the Crossfire of Health Policy Debates

    May 13 | 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. More

  • ‘Better Stethoscope’ Could be First Step in Diagnosing Heart Valve Disease

    May 08 | 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. More

  • Saliva Test Could Help Oncologists Know When to Avoid Common Cancer Drug

    May 06 | 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. More

  • By Focusing on Nearer-Term Incremental Change, We Can Pave the Way to Multi-Cancer Early Detection Tests

    May 02 | 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. More

  • Cleveland Diagnostics’ New Study, Illumina, Tempus AI Collaborate, LinusBio, BRAIN Foundation Partnership, More

    Apr 30 | 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. More

  • Follow the Money: Degenerative Eye Disease Treatments, Antibodies for Multiple Diseases, More

    Apr 29 | 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. More

  • Researchers Identify Better Biomarker for Stroke and Dementia Risk

    Apr 23 | 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. More

  • ‘Lab-in-a-Box’ Diagnostics in the Post-Theranos Era

    Apr 22 | Diagnostics World | The clinical relevance and limitations of so-called “lab-in-a-box” (LIAB) diagnostics, which surged in popularity during the COVID pandemic, have since that time been under considerable scrutiny, most notably among investors still spooked by the notorious Theranos scandal. One of the more enduring problems among LIAB developers is that they tend to get “blinded by the beauty” of their technology. More

  • Immunosensor Could Improve Blood-Based Testing for Colorectal Cancer

    Apr 17 | Diagnostics World | Researchers at The University of Texas at El Paso (UTEP) are developing a point-of-care device for diagnosing colorectal cancer which, like blood glucose devices, uses electrochemical sensors. The microchip electrode features an immunosensor that detects disease biomarkers in a drop of blood, opening the possibility of an accessible, inexpensive test for the nation’s second leading cause of cancer-related deaths. More

  • ‘Funky Shape’ Gets Magnetic Robots Rolling in the Colon in Search of Cancer

    Apr 16 | Diagnostics World | Magnetic flexible endoscopes (MFEs) have up to now had a few disadvantages limiting their use inside the human body for performing virtual biopsies, notably navigation-related difficulties related to their traditional cylindrical shape. These robot-assisted devices use magnetic forces to propel and maneuver through lumens like the colon, but rotation happens in only two directions that limits the scope's ability to effectively perform procedures. More
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