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Precision Biopsy submits IDE application to FDA to expand clinical trial of ClariCore Biopsy system

MDBR Staff Writer Published 31 March 2016

Precision Biopsy announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for permission to enroll patients in the Transrectal Ultrasound (TRUS) and MR/Fusion arm of the company’s study, expanding the scope of a clinical trial for its ClariCore™ Biopsy System in prostate cancer patients.

ClariCore is a device platform designed to provide accurate, real-time classification of prostate tissue during biopsy procedures.

The TRUS- and MR/Fusion-guided biopsy studies would build upon the Retropubic Radical Prostatectomy (RRP) study that Precision Biopsy already has underway at the University of Colorado. The company has successfully completed five RRP procedures under local Institutional Review Board (IRB) approval in Colorado.

"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," said Dr. E. David Crawford, Professor, Radiation Oncology and a practicing surgeon at the University of Colorado.

"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."

The three arms of Precision Biopsy's Cohort A clinical trial aim to collect prostate tissue and associated optical responses to help develop the ClariCore System's real-time tissue classification algorithm.

In addition to enrolling patients at the University of Colorado, Precision Biopsy has received IRB approvals at Johns Hopkins Hospital in Baltimore and Memorial Sloan Kettering Cancer Center in New York, and will soon begin enrollment of RRP patients at those sites. In total, about 200 patients will be included in the algorithm development trial.

"The ClariCore Optical Biopsy System offers the opportunity to minimize unnecessary coring and reduce costs," said Amir Tehrani, Chief Executive Officer of Precision Biopsy. "We look forward to furthering the development of our ClariCore system with the support and collaboration of these leaders in the medical community."

Equipped with an optical fiber and companion console, Precision Biopsy's ClariCore system performs spectral analysis 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 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," 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.

These TRUS-guided prostate biopsies also miss as much as 30 percent of cancers that require therapy. Reducing that error rate could have measurable impact: In the U.S., about 28,000 men die each year from prostate cancer, according to the American Cancer Society.



Source: Company Press Release