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Diagnostics World News | The FDA’s Center for Devices and Radiological Health is seeking to advance innovation in microfluidics-based medical devices with the development of a regulatory science tool for leakage testing. A growing number of diagnostic and therapeutic medical devices use microfluidics technology and leakage testing has emerged as a nontrivial issue that can contribute to device failure.
Sep 1, 2022
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Diagnostics World News | Impaired heart metabolism, signaled by low adenosine triphosphate levels detected by an MRI test, may be able to predict future sudden cardiac death. If so, the measurement would help answer the million-dollar question of who needs an implantable cardioverter defibrillator to monitor and treat life-threatening electrical problems with the heart.
Sep 1, 2022
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Diagnostics World News | The relative merits and drawbacks of using antigen tests rather than molecular assays during outbreaks of emerging infectious diseases was the topic of a lively debate held at last week’s Next Generation Dx Summit in Washington, D.C. The team arguing against antigen testing ultimately won the debate by swaying a healthy percentage of the audience to their side.
Aug 31, 2022
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Diagnostics World News | An ultramodern laboratory for prostate cancer diagnoses opens in Sweden; a flow cytometry-based companion diagnostics platform matches patients with life-changing treatments for cancer and other diseases; a new RNA-targeted oncology pipeline boasts therapeutic and diagnostic capabilities; and more.
Aug 31, 2022
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Diagnostics World News | The pros and cons of the Verifying Accurate Leading-edge IVCT Development Act, was the topic of a lively panel discussion during last week’s Next Generation Dx Summit in Washington, D.C. Those supporting the legislation, point to several promising provisions added over the past few months as well as the importance of leveling the playing field so all test developers are held to the same evidentiary standard.
Aug 30, 2022
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Diagnostics World News | Funding for COVID-19 Omicron subvariant surveillance, ultrasensitive genetic optical detection, rapid multi-pathogenic testing, and more.
Aug 30, 2022
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Diagnostics World News | A long list of clinical services, including point-of-care testing, could be implemented in the community pharmacies which, especially during the pandemic, have become public health destinations. Pharmacists predict that 2022 will be a “banner year” for POC testing in community pharmacies and emerge as test-and-treat locations for infectious conditions beyond COVID.
Aug 26, 2022
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Diagnostics World News | Oregon Health & Science University researchers created a new imaging technique to predict at-risk pregnancies with funding from the National Institutes of Health’s Human Placenta Project.
Aug 25, 2022
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Diagnostics World News | The clinical utility of genetic testing has been newly redefined to reflect the realities of modern cancer care. The education, advocacy, and evidence-developing organization, Personalized Medicine Coalition, championed efforts to pen the update through a roundtable event sponsored by Genentech.
Aug 24, 2022
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Diagnostics World News | The Mayo Clinic has made a discovery that could help explain why some people who get infected with the SARS-CoV-2 virus suffer badly while others feel only mildly ill.
Aug 24, 2022
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Diagnostics World News | Meeting the needs of patients, providers, and payers will be key to overcoming the limitations of current point-of-care testing methods. Many of the longstanding obstacles—including limited research funding, dependency on central labs, and general unfamiliarity with diagnostic testing—have already been resolved by the ongoing pandemic.
Aug 23, 2022
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Diagnostics World News | Radiomics-based machine learning models have been shown to do an impressive job of detecting pancreatic cancer on pre-diagnostic CT scans several months before symptoms appear, suggesting that one day the disease will more often be diagnosed at a stage where a surgical cure may be possible.
Aug 23, 2022