Precision Biopsy

About Precision Biopsy

Precision Biopsy, LLC operates within the medical diagnostic equipment sector, focusing on the development and commercialization of technologies to improve the accuracy of prostate cancer detection. The company was founded in 2008 and formed as a subsidiary of Allied Minds, a U.S. science and technology commercialization firm, in partnership with the University of Colorado.

The scientific foundation of the company stems from the extensive research of University of Colorado professors Priya Werahera and John Daily. Dr. Werahera, a translational researcher focused on new diagnostic methods for prostate cancer, and Dr. Daily, an expert in mechanical engineering, combined their knowledge of advanced spectroscopy and tissue morphology to create the core technology. Their collaboration, which began conceptually around 2002, aimed to solve the high rate of missed cancers in standard random biopsies. This work led to the creation of the ClariCore™ Biopsy System, with the first-generation system developed in 2011 and initial human evaluations in 2012. The technology was licensed from the University of Colorado, and Dr. Werahera served as the company's Chief Scientific Officer.

Precision Biopsy's core product is the ClariCore™ Biopsy System, a medical device platform designed to provide accurate, real-time classification of prostate tissue during a biopsy procedure. The system addresses the significant drawbacks of traditional transrectal ultrasound (TRUS)-guided biopsies, which can miss up to 30% of cancers and result in 90% of collected tissue cores being benign. The ClariCore system integrates an optical fiber into a biopsy needle, which uses a combination of fluorescence and elastic-scattering spectroscopy to analyze tissue in real-time. An AI-powered algorithm instantaneously analyzes the light returned from the tissue to classify it as suspicious or benign before a sample is taken. This allows urologists to make more informed decisions during the procedure, potentially reducing the number of unnecessary core samples taken by up to 90% and improving the diagnostic yield. The system also has capabilities for creating precise 3D maps of tumors, which is a critical step for enabling targeted focal therapies that treat the cancer while sparing healthy tissue.

The company's business model centers on the sale of these diagnostic devices to healthcare providers, such as hospitals and urology clinics. By offering real-time information, the system aims to enhance patient outcomes, lower healthcare costs associated with pathology and repeat procedures, and reduce patient anxiety. The company has secured significant funding to advance its technology, including a notable $33.6 million round in October 2015, led by Woodford Investment Management with participation from Allied Minds, which valued the company at over $90 million. In September 2016, Precision Biopsy received Investigational Device Exemption (IDE) approval from the FDA to expand clinical trials for the ClariCore system.