Precision Biopsy asks FDA to OK new ClariCore trial

Precision Biopsy said today it submitted an application to the FDA seeking a go-ahead to expand the trial of its ClariCore prostate biopsy system into a new Transrectal Ultrasound and MR/Fusion arm.

The ClariCore system is designed for the spectral analysis of tissue samples during biopsies to “rapidly classify” tissue as normal or suspicious using an optical fiber and companion console designed to minimize the number of samples taken by up to 90%, the company said.

“We evaluated the ClariCore device in several of my patients during an operative procedure to remove the prostate, and came away highly impressed with the system. I support the clinical trials planned by Precision Biopsy, as its technology has the potential to significantly improve the diagnostic process for millions of patients who undergo biopsy procedures each year to monitor for prostate cancer, the second-most deadly cancer in men,” Dr. E. Crawford of the University of Colorado said in a press release.

All 3 arms of the company’s Cohort A clinical trial look to collect prostate tissue and associated optical responses to help develop the ClariCore System’s real-time tissue classification algorithm, the company said. A total of 200 patients are slated to be enrolled in the algorithm development trial.

“The ClariCore Optical Biopsy System offers the opportunity to minimize unnecessary coring and reduce costs. We look forward to furthering the development of our ClariCore system with the support and collaboration of these leaders in the medical community,” CEO Amir Tehrani said in prepared remarks.

“The expansion of our clinical testing at Precision Biopsy is a tribute to our team and the performance of the technology. We are thrilled to see this advance,” board member Dr. Omar Amirana said in a prepared statement.

Last October, Precision Biopsy said it raised $33.6 million in a new round of equity financing to support its ClariCore biopsy platform designed to provide prostate tissue classification during biopsy procedures.

Woodford Investment Management led the round, according to Aurora, Colo.-based Precision Biopsy, with investments from its parent company Allied Minds.

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