Precision Biopsy announced that its application for an Investigational Device Exemption (IDE) was approved by the U.S. Food and Drug Administration (FDA), allowing the company to expand its clinical trial for the ClariCore Biopsy System by enrolling prostate cancer patients in the Transrectal Ultrasound (TRUS) and MR/Fusion arms of its study.
ClariCore is designed to provide accurate, real-time classification of prostate tissue during biopsy procedures.
Precision Biopsy’s Cohort A clinical trial aims to collect prostate tissue and associated optical signatures to help develop the ClariCore System’s real-time tissue classification algorithm.
About 200 patients will be included in the three arms of the trial, which is taking place across the U.S. at sites including the University of Colorado, Johns Hopkins Hospital in Baltimore and Memorial Sloan Kettering Cancer Center in New York.
Additional patients for the Cohort A are expected to be enrolled at three new sites, including Carolina Urologic Research Center in Myrtle Beach, South Carolina; Associated Medical Professionals in Syracuse, New York; and The Urology Center of Colorado in Denver.
Precision Biopsy has already enrolled 33 patients in its Retropubic Radical Prostatectomy (RRP) study at Johns Hopkins Hospital, Memorial Sloan Kettering Cancer Center and the University of Colorado, more than half the number of patients required to complete this arm of the trial.
“The approval from the FDA marks an important step forward in our efforts to finalize development of the ClariCore Optical Biopsy System and help to improve the biopsy process for patients being evaluated and monitored for prostate cancer, the second-most deadly cancer in men,” said Amir Tehrani, Chief Executive Officer of Precision Biopsy.
“We are looking forward to enrolling prostate biopsy patients in the Cohort A clinical trial using the ClariCore Optical Biopsy system. ClariCore is a breakthrough technology that should both benefit patient outcomes and also reduce healthcare costs,” said Dr. Neal D. Shore, Director of Carolina Urologic Research Center.
Equipped with an optical fiber and companion console, Precision Biopsy’s ClariCore system performs spectral analysis of prostate tissue during a prostate biopsy, providing in-vivo tissue classification that seeks to minimize the number of normal core samples taken by up to 90 percent, while offering actionable diagnostic information at the time of the biopsy.
“The ability to expand the trial is an important milestone in the development of the ClariCore system and we are excited by the progress achieved by the Precision Biopsy team,” said Omar Amirana, MD, Precision Biopsy Board member and Senior Vice President at its parent company, Boston-based Allied Minds.
More than 2 million men worldwide undergo TRUS-guided prostate biopsies each year due to risk factors that include elevated PSA levels, physical exam abnormalities and family history. Of the 12 million biopsy core samples that are analyzed, less than 10 percent are shown to be positive for cancer — at a cost of nearly $1 billion dollars in the U.S. alone.