FDA Gives Breakthrough Device Status to 4D Path’s Breast Cancer Diagnostic Platform

FDA Gives Breakthrough Device Status to 4D Path’s Breast Cancer Diagnostic Platform
The U.S. Food and Drug Administration (FDA) has designated 4D Path’s software a breakthrough device as a possible way to achieve a faster and more accurate breast cancer diagnosis based on tissue taken in a breast biopsy or resection. Named 4D Q-plasia OncoReader Breast, the software is intended to aid doctors in evaluating biopsies and resections (tumors that are surgically removed), and in achieving a more accurate diagnosis. “We are thrilled that the FDA has recognized the potential of our technology to offer significant advantages over existing approved or cleared alternatives to establish long-term clinical efficiencies. Our device acts on par with a diagnostic histopathologist in the identification of invasive cancer," Nic Orsi, PhD, chief pathologist for 4D Path, said in a press release. Breakthrough device status is given to medical technologies that may lead to more effective diagnosis or treatment for life-threatening or debilitating conditions. It fosters closer and more frequent meetings with the FDA to speed access to a promising product by supporting its development and review, and grants prioritized review for subsequent submissions. While in a breast biopsy a small piece of tissue is collected for clinical evaluation and diagnosis, in a resection — a more invasive procedure — doctors surgically remove as much as possible of a tumor to evaluate. Traditionally, images obtained via these methods are analyzed under a microscope by a pathologist, who assesses the different clinical features of tumor cells, like aggressiveness and cancer grade. The variability in the visual inspection of these images, including discordance among physicians, has been reported as a major cause of diagnostic inaccuracies. Moreover, tumors are made
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