gap project portfolio » OmnEcoil Instruments, Inc.
- Duffy Dufresne, CEO
Project Title: Novel fixed curved array multichannel device for MRI targeted prostate biopsy
Prinicipal Investigator: Dr. Fergus Coakley, Oregon Health and Sciences University
Company: OmnEcoil Instruments, Inc.
OmnEcoil Instruments is developing a new patent-pending biopsy device that will enable the collection of prostate biopsies in a one-step procedure (vs. the existing two-step process) with reduced false negative results, improved diagnosis of cancer virulence, and reduced patient morbidity. The current standard-of-care for prostate cancer diagnosis is systematic transrectal ultrasound-guided biopsy (or TRUS-guided biopsy) – a procedure that employs an ultrasound probe to obtain 12 or more needle core biopsies from the prostate. The biopsy samples are obtained from randomized locations on the prostate due to ultrasound’s limitations with visualizing cancerous lesions. This standard approach is associated with disturbingly high rates of false negative diagnosis (missed cancer, 15-46%), overdiagnosis (detection of indolent Gleason 6 cancer of questionable clinical significance, 45%) and underdiagnosis (undergrading of the cancer when compared to the final surgical pathology, 38%). An alternative procedure, MRI-guided prostate biopsy, can accurately visualize likely cancerous sites for biopsy and has been shown to reduce the rates of false negative diagnosis, overdiagnosis, and underdiagnosis. This two-step procedure first involves a Diagnostic MRI of the prostate, which is best performed with an endorectal coil inside the rectum as this increases tumor detection from 45% to 76%, and is followed days later with an MRI-guided biopsy. The MRI-guided biopsy also requires that a device be placed in the rectum – a single channel needle guide used to direct the biopsy needle to cancerous lesions on the prostate – making this a two-part procedure, performed separately, on different days, with obvious potential healthcare costs. OmnEcoil is developing a new biopsy device – funded in part by ONAMI’s Launch Grant – which combines an MRI endorectal coil and biopsy needle guide into one instrument, allowing for the simultaneous conduct of two procedures (diagnostic MRI and MRI-guided biopsy). When used in tandem with MRI-guided biopsy, OmnEcoil’s biopsy device will be a win-win, providing tumor localization and increased accuracy, reduced costs to patients and the healthcare system, and a more convenient and comfortable procedure for prostate patients.