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    Product Preview: Liquid Bx accurately identifies high-grade PCa

    Liquid biopsy accurately identifies high-grade prostate cancer 

    Exosome Diagnostics, Inc. recently announced positive data from an initial clinical study of the company’s novel prostate cancer liquid biopsy. The noninvasive, RNA-based test demonstrated the potential to accurately predict high-grade prostate cancer by analyzing biomarkers on exosomal RNA via a urine sample. The prostate cancer liquid biopsy is being developed to noninvasively assess the risk for high-grade prostate cancer in men with an elevated gray zone PSA (2.0–10.0 ng/mL). The data were presented at the Genitourinary Cancers Symposium in Orlando, FL.

    READ: Product offers benefit to PCa patients undergoing RT

    Maker of HIFU device to pursue direct de novo 510(k) clearance

    Based on a recent meeting with the FDA, EDAP TMS SA says it plans to seek clearance of Ablatherm high-intensity focused ultrasound by way of a direct de novo 510(k) application as opposed to the pre-market approval application amendment the company had been pursuing. The FDA indicated that while pre-market approval would be required for specific claims regarding treatment of prostate cancer, a prostate tissue ablation claim could be cleared via a direct de novo 510(k) application.

    Southern Illinois University awarded grant to develop ED prosthesis

    The division of urology at Southern Illinois University School of Medicine, Springfield has received a $65,868 grant from American Medical Systems, Inc. to support the development of a novel physiologic prosthesis for the treatment of erectile dysfunction. Kevin McVary, MD, and Alberto Colombo, PhD, of the Southern Illinois division of urology are leading the development of the device, according to a news release from the university.

    NEXT: Companies announce agreement on PCa immunotherapy

    Benjamin P. Saylor
    Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.


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