Seoul, South Korea- Deep Bio announced today that it had officially commenced clinical trial on ‘DeepDx-Prostate,’ a prostate biopsy AI-based diagnostic software. Deep Bio has recently received clinical trial plan approval from the Ministry of Food and Drug Safety for ‘DeepDx-Prostate’ and its clinical validation plan on AI-based diagnosis using prostate biopsy based H&E stained digital images.
Deep Bio will go through a verification and validation of the AI-based diagnostic software on patients who have undergone prostate biopsy using H&E stained digital images. The clinical trial will be conducted at two academic hospitals (Seoul National University Hospital, Korea University Guro Hospital) and will compare the diagnostic results between clinicians and the DeepDx-Prostate. In addition, the trial will evaluate the effectiveness of the diagnostics using AI-based software.
Pathologists confirm the diagnosis of prostate cancer through examining the prostate tissue H&E slides under a microscope. While the current examination process is pathologists visually interpreting & measuring the slides, on DeepDx-Prostate, it can analyze and calculate the percentage of cancer in the entire tissue based on pixel level. These analysis results automatically generate in the form of a pathology report. The report includes the patient’s cancer staging based on the Gleason grading system. “DeepDx-Prostate is an AI-software that assists pathologists in making decisions on cancer diagnosis, and it can further help them with selective precision readings,” Deep Bio officials said. Deep Bio is expecting approval as early as this year.
Deep Bio is pursuing to expand in the global market. In 2018, they had granted compliance on ISO13485:2016, and will soon commence on receiving European CE certification and FDA approval. The founder and CEO of Deep Bio, Kim Sun Woo said, “we are continuously expanding our global network by participating in international conferences such as USCAP, AACR and introducing our products. We plan to speed up the development process in other cancer types, such as breast cancer diagnosis.”