Q&A: PrecisionPoint: A safer approach to biopsy?

Med-Tech Innovation News spoke to Dr. Matthew J Allaway, a urologist at Urology Associates in Maryland and designer of the PrecisionPoint system in a bid to provide a safer approach to biopsy. 

The inspiration for the device appears to have come from your own experience with cancer, what aspects of that experience drove you to develop this device?

My philosophies and attitudes regarding patient care resulted from my own personal battle with testicular cancer. Being a patient yourself really teaches you the most valuable lessons about being a physician. After my experience, I better recognised that providing the utmost quality of care and putting patients’ perspectives first is essential, and that sometimes less is more. As a urologist focussed on prostate cancer, I understood that the standard of care for prostate cancer detection is the transrectal biopsy, but this approach is associated with a risk of serious infection and other complications. I decided that the risks associated with the transrectal biopsy were unacceptable for patients, and I started the journey to develop a safer approach.

What is different about it compared to other tests?

I developed a new device and surgical approach to diagnose prostate cancer called the PrecisionPoint Transperineal Access System. PrecisionPoint uses a safer, more precise route for taking tissue samples of the prostate by performing a biopsy via the transperineal approach. A transperineal biopsy takes samples of the prostate by passing a needle through the perineum (the area of skin between the rectum and the scrotum) whereas a transrectal biopsy passes a needle through the rectum. The transperineal approach with PrecisionPoint allows physicians to sample the prostate gland thoroughly, with patients experiencing only two needle punctures in the skin with virtually a 0% risk of infection.

Tell us about how the device behind the test is made? What does it consist of?

The PrecisionPoint system, designed and manufactured in the U.S., consists of three key components: an adjustable clamping mechanism, stabilisation bars, and a carriage with an access trocar. The clamp is designed to prevent any movement relative to the ultrasound probe during a biopsy to provide stability and to prevent axial and rotational movement of the device. It was also made to fit a variety of existing ultrasound probes of different diameters, allowing urologists to use their existing equipment in many cases. The stabilisation bars are fixed to the clamp and allow the entire device to interface with the perineum and subcutaneous tissue. The bars also allow urologists to disengage the device and change position during a biopsy should they choose. Lastly, the carriage with access trocar is fixed onto rails that attach to the stabilisation bars, allowing the carriage to slide down the rails and advance deep into the perineum. This component prevents independent movement while urologists take biopsy samples, ensuring stabilisation and accuracy. The carriage was also designed with fits and features to protect patient safety, given the intimacy of the procedure. It disengages prior to harming a patient if excessive force is applied.

How does the approach you developed lead to a reduction in the infection risk?

PrecisionPoint results in a reduced risk of infection by allowing physicians to perform a biopsy by entering through the skin (i.e., the perineum) rather than through the rectum as seen with the transrectal approach. By going through the rectum, a transrectal biopsy puts patients at risk of infection from faecal matter that can be introduced into the prostate with each pass of the biopsy needle. A transrectal biopsy is associated with about a 5-7% infection rate, whereas a transperineal biopsy with PrecisionPoint is associated with about a 0% infection rate.

Such examinations can be associated with some discomfort for patients, is this any different?

A transperineal biopsy with PrecisionPoint requires only two needle sticks in the perineum, presenting little or no discomfort to patients, compared to a transrectal biopsy which requires about 12 needle sticks through the rectum, which can present complications including pain, rectal bleeding, urinary retention, and erectile dysfunction. A transperineal biopsy with PrecisionPoint also offers patients (and physicians) the convenience of being able to perform the procedure in an office setting under local anaesthesia whereas a transrectal biopsy must be performed in an operating room under general anaesthesia. Patients who undergo a PrecisionPoint biopsy are generally able to return to their usual daily activities almost immediately after the procedure.

What further developments do you envisage in this area? Particularly from medtech?

The ideal management of men’s health includes an annual prostate specific antigen (PSA) blood test and a digital rectal examination (DRE). The blood test monitors for increases in a man’s PSA levels over time, which can be an indication of prostate cancer and need for a biopsy to confirm a diagnosis. But the recommendation for PSA screening has been controversial in the past. In the future I hope to see more sensitive and specific biomarkers used to monitor for prostate cancer as well as possible recurrences of the disease. The development of better biomarker tests might help to detect prostate cancer earlier when it might be more easily treated and potentially prevent unnecessary prostate biopsies.

Anything else you’d like to add?

A transperineal biopsy with PrecisionPoint is currently being used in the U.S. and 13 other countries. There are also many regions around the world where transrectal biopsies are being actively phased out in favour of a transperineal biopsy, given it offers a safer option for patients. The European Association of Urologists (EAU) has changed their prostate biopsy guidelines to recommend that a transperineal biopsy be offered unless it cannot be performed for certain reasons. In Australia, reimbursement for prostate cancer biopsies has been reduced for physicians who use the transrectal approach to incentivise using the transperineal approach. I am confident that the transperineal approach to prostate cancer biopsy will become the new standard of care in the years ahead.