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Diagnostics World | It is no surprise that clinical trial sponsors are slowly embracing new tools and technologies to achieve greater levels of precision and efficiency needed in an increasingly demanding and competitive drug discovery and development landscape. Where there was once hesitation due to the unknowns of straying from historical analytic processes, there has been exponential growth in the application of digital pathology within clinical research and development efforts in recent years.
Oct 4, 2024
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Diagnostics World | Proscia yesterday launched Concentriq Embeddings for whole slide images and the Proscia AI Toolkit, a collection of tutorials and functions to help teams rapidly integrate Concentriq Embeddings into their workflows.
Oct 3, 2024
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Diagnostics World | In a first for genetic diagnostics, a pair of Nobel-Prize-winning technologies are being repurposed for obtaining RNA from disease-causing genes that are expressed in neither blood nor skin. The feat comes from the Neurobiology Research Group at the University of Adelaide’s School of Biomedicine, led by Lachlan Jolly, Ph.D., which aims to resolve the pathogenicity of 300 variants of uncertain significance (VUSs) under a government-funded, Australia-wide study.
Oct 1, 2024
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Diagnostics World | Inflammatix plans to get its lead product, the TriVerity Acute Infection and Sepsis Test (TriVerity), out to market; Syantra aims to commercialize its first test on its patent-pending platform for early detection of breast cancer; and more.
Sep 26, 2024
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Diagnostics World | QIAGEN has entered a collaboration with Eli Lilly to support the development of a QIAstat-Dx in-vitro diagnostic (IVD) to detect APOE genotypes; Illumina welcomed the European Court of Justice's judgment ruling that the European Commission did not have jurisdiction over Illumina's acquisition of GRAIL; Ambry Genetics announced enhancements to their portfolio of tests for the detection of genetic mutations associated with hereditary cancer; and more.
Sep 25, 2024
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Diagnostics World | Researchers at the Mayo Clinic have developed a new tool that uses machine learning to analyze a stool sample to provide insights into your gut health. The tool, called the Gut Microbiome Wellness Index 2 (GMWI2), can detect subtle changes in the gut to see if one is progressing toward better health or possibly developing a disease.
Sep 19, 2024
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Diagnostics World | The push in personalized medicine to look beyond the genome has netted quite a few valuable ‘omics technologies. Linus Bio is tracking environmental exposures recorded over time in hair. Manish Arora, CEO and founder of LinusBio, believes the platform will “revolutionize personalized medicine.”
Sep 18, 2024
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Diagnostics World | Daye, a women's health startup, is addressing the gender diagnostic gap with a novel self-sampling tampon that collects vaginal and cervical fluids for STI and HPV testing. Lindus Health collaborated with Daye to enroll 250 diverse participants and run the STAMP trial evaluating the efficacy of the diagnostic tampon for STIs and bacterial vaginosis (BV).
Sep 17, 2024
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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).
Sep 12, 2024
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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.
Sep 10, 2024
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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.
Sep 5, 2024
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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.
Sep 4, 2024
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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).
Sep 3, 2024
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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.
Aug 29, 2024
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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.
Aug 28, 2024
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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.
Aug 26, 2024
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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.
Aug 23, 2024
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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.
Aug 21, 2024
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Diagnostics World | New technology, powered by artificial intelligence (AI), aims to bring breast and ovarian cancer patients the expected value of genomic sequencing—a more precise diagnosis and personalized treatment strategy—potentially without ever having their DNA analyzed.
Aug 20, 2024
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Diagnostics World | Last week, Paige, in collaboration with Microsoft, unveiled the second generation of Virchow, its million-slide foundation model for cancer. Virchow2 and Virchow2G offer a deeper understanding of cells and tissue, aiming to redefine cancer diagnosis and treatment.
Aug 16, 2024