It was one of the worst days of Tom Neville's life. It was in January 2002 when he had just gone to get a physical at the Cleveland Clinic, when his doctor told him that his PSA tested a little high. Neville was shortly thereafter diagnosed with prostate cancer.
"When I got that call, I didn't know a bit about prostate cancer," Neville told Medical Device Daily. "I thought I was going to die."
But treatment prevented such a scenario from happening and opened up a new opportunity for Neville and men who have been tested for prostate cancer. The engineer by trade formed his own company, Soar BioDynamics (San Francisco), in 2005 and is now its CEO as well as chief scientist.
The company just recently released its first product — Soar Dynamic Screening for the prostate. Developed in conjunction with a plethora of researchers in urology, Soar Dynamic Screening demonstrates what the company is calling a new approach to healthcare by providing men a detailed analysis of their prostate health based on several factors beyond the industry-standard prostate-specific antigen (PSA) test.
Because the PSA test is controversial as a stand-alone tool, Soar Dynamic Screening also analyzes other important variables, including a man's personal health history, PSA trends over time and comparisons with up to a million case studies.
The National Cancer Institute (NCI) released a study recently stating that annual prostate screenings have no mortality benefit (Medical Device Daily, March 26, 2009) and that there needs to be an intense focus on other ways that physicians test patients for cancers.
Neville said that Soar BioDynamics' analysis is one such option.
"This is bringing a mathematical analysis from multiple cancer tests," he said. The analysis has been in development for 3-1/2 years now."
Here's how it works.
Through a web-based tool, men enter the results of their PSA test history and personal information such as height, weight and health history. This information is compared with up to a million case studies and outcomes from other men with various prostate conditions. Finally, the system may suggest a medical detective process for doctors and their patients in their efforts to detect non-cancerous prostate conditions and improve prostate cancer screening.
Soar provides men with 20 opportunities annually to analyze their prostate health data, enabling ongoing, up-to-date analyses when needed to support men and their doctors' efforts to conduct medical detective processes.
Men are then asked to take their report with them for their next consultation with their doctor and discuss it. The company will then suggest the timing for the next PSA test and a digital rectal exam as part of a physical and may suggest other actions, such as a prostate volume measurement or prostatitis detection process. But, as the company says, it is up to the patient and the doctor to make actual choices about what to do about health concerns.
The company keeps confidential statistical information on file indefinitely in its secure database and encourages patients to maintain membership with the company so that it can request future reports over time that build on previously entered information.
All too often men are misdiagnosed from levels of high PSAs and they go through unnecessary biopsies, according to Neville.
"One of the main things fooling doctors is an elevated PSA, which could just be inflammation or infection of the prostate," he told MDD.
"As recent studies have again proven, one PSA test does not deliver enough information," said Georg Bartsch, MD. "It is vitally important to monitor indicators over time and provide men with personalized analysis of their prostate health."
This isn't a medical test in a true sense, since the procedure doesn't need FDA approval. But Neville said the company plans to eventually bring it before the agency for review.
"I was confused like most guys," he said. "I didn't know anything about prostate cancer. There were no clear answers to the questions I had surrounding my health, and I was confronted with irrevocable procedures that might have been unwarranted."
He added, "I founded Soar because I did not want any other man to go through such a life-altering process without being armed with personalized information and analysis to help make decisions."