• Texas District Court Vacates FDA LDT Rule

    Apr 01 | Diagnostics World | The U.S. District Court for the Eastern District of Texas granted a motion for summary judgment yesterday, vacating the FDA rule that would have regulated LDTs as medical devices under the Federal Food, Drug and Cosmetic Act. More
  • PathAI’s Pathology Assessment Tool, Mayo Clinic Collaboration, More

    Mar 27 | Diagnostics World | PathAI received full qualification for AIM-MASH AI Assist1; Mayo Clinic Laboratories and Amprion announced a collaboration to expand access to Amprion's SAAmplify–αSYN (CSF) test across the United States; and more. More
  • Follow the Money: Shingles Vaccine, Blood Stem Cell Therapies, More

    Mar 26 | Diagnostics World | Curevo will advance development of amezosvatein, the company’s vaccine for shingles; Garuda aims to address the growing need for off-the-shelf and cost-effective solution to stem cell transplants; and more. More
  • GE HealthCare, NVIDIA Pursue Autonomous X-Ray, Ultrasound

    Mar 20 | Diagnostics World | GE HealthCare announced a collaboration this week with NVIDIA, expanding the existing 16-year relationship between the two companies to focus on pioneering innovation in autonomous imaging, beginning with autonomous X-ray technologies and autonomous applications within ultrasound. More
  • Device Predicts Metastatic Risk by Measuring Stickiness of Cancer Cells

    Mar 19 | Diagnostics World | Based on the discovery that the adhesion strength of cancer cells scales inversely proportional to the invasiveness of a tumor, researchers at University of California, San Diego have built a microfluidic device with the hope that it can be used in the future to diagnose the metastatic potential of ductal carcinoma in situ (DCIS) breast cancer tumors. More
  • Early Bladder Cancer Detection Just the Beginning for This At-Home Urine Test

    Mar 18 | Diagnostics World | The incidence of bladder cancer is rising significantly due to population aging and, while survival rates are relatively high, when diagnosed late patients may need to undergo bladder removal regardless of survival. Early detection and treatment of bladder cancer are therefore crucial to preserving the organ and maintaining the patient’s quality of life. More
  • Venture Capital Steps in Amid Government Funding Uncertainty

    Mar 13 | Diagnostics World | Altitude Lab, a nonprofit established by biotech company Recursion, has launched a pre-seed venture fund aimed at supporting 10 to 15 early-stage startups navigating the current uncertainty surrounding government funding. Executive Director Chandana Haque hopes other private investment groups will follow suit to bridge the gap left by disrupted Small Business Innovation Research (SBIR) grants, which have historically been crucial in launching startups and securing follow-on investments. More
  • Platelet Function Test Could Help Doctors and Scientists Tackle Heart Disease

    Mar 11 | Diagnostics World | A new platelet function test has been developed by researchers in the UK that could help pharmaceutical companies design better, safer drugs for the prevention of heart attacks and strokes and, longer term, to help doctors know which of their high-risk patients should be put on blood thinners. Ultimately, the test could be developed into a point-of-care preventive diagnostic for the general population that’s as simple to use as a blood glucose fingerprick test. More
  • Personalis ctDNA Test Paves Way for Medicare Reimbursement in Breast Cancer

    Mar 06 | Diagnostics World | A retrospective study from Personalis for its NeXT Personal test, an ultra-sensitive circulating tumor DNA (ctDNA) test for cancer patients and survivors, has been published in Annals of Oncology. The study was conducted with researchers from The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust in the UK. More
  • Methylation Monitoring Predicts Pan-Cancer Outcomes

    Mar 05 | Diagnostics World | In a paper published last month in Nature Scientific Reports, authors validate Northstar Response, BillionToOne's novel tissue-free circulating tumor DNA (ctDNA) liquid biopsy test that enables physicians to monitor cancer treatment response in Stage III-IV cancers with a blood draw. More
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