Precision Biopsy gets IDE approval from FDA for ClariCore Biopsy System

11 September 2016 (Last Updated September 11th, 2016 18:30)

Medical device company Precision Biopsy has obtained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to expand the clinical trial of its ClariCore Biopsy System for prostate cancer.

Medical device company Precision Biopsy has obtained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to expand the clinical trial of its ClariCore Biopsy System for prostate cancer.

The ClariCore system, fitted with an optical fiber and companion console, conducts spectral analysis of prostate tissue during a prostate biopsy, offering in-vivo tissue classification which reduces the number of core samples to be examined while providing diagnostic information during the biopsy.

Spectral analysis involves the use of light to spot the tissue to provide real-time information which paves the way for timely diagnosis.

"Approximately 200 patients are planned to be included in the three arms of the trial conducted by Precision Biopsy."

The ClariCore Biopsy System uses spectral analysis with a highly predictive algorithm to rapidly classify a normal and a suspicious tissue.

Precision Biopsy’s Cohort A clinical trial will enroll prostate cancer patients in the Transrectal Ultrasound (TRUS) and MR / Fusion arms of its study.

It will collect prostate tissue and associated optical signatures to aid the development of ClariCore System’s real-time tissue classification algorithm.

Approximately 200 patients are planned to be included in the three arms of the trial conducted by Precision Biopsy.

Precision Biopsy CEO Amir Tehrani said: “The approval from the FDA marks an important step forward in our efforts to finalise 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.”