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INDIANAPOLIS (AP) — An Indianapolis company founded to run DNA tests on crime scene evidence is now using the same technology to solve false positives on cancer biopsies and prevent doctors from operating on patients who don't need it.
Strand Analytical Laboratories, which was founded by former Marion County Prosecutor Scott Newman, began shifting its focus after a company official saw a news report about a Boston man who had unnecessary prostate surgery after his biopsy was switched with that of a man who had cancer.
"We realized what we do on a forensic basis every day could be easily adapted to the clinical setting to solve this problem," chief financial officer Travis Morgan told The Indianapolis Star (http://indy.st/1wQvj3Q ). "It was really sort of by accident."
The company's Know Error system has been used on about 175,000 patients who have undergone breast and prostate biopsies. About 6 percent of all prostate biopsies and 1 percent of all breast biopsies use the Know Error system, Morgan said, and the company would like to see that expand.
Demand for the service has far exceeded the lab's original forensic science work, with crime tests making up only about 10 percent of Strand's work.
Errors resulting from medical biopsies are a growing, and costly, phenomenon. Some medical malpractice law firms even specialize in such cases. A study done by Strand Diagnostics scientists in conjunction with others found that such mistakes occur in about 2.5 percent of all prostate biopsies, leading to misdiagnoses in about 1 in every 200 patients. That results in an estimated $879.9 million in wasted medical treatment costs, of which $694.8 million comes in medical legal expenditures.
"The conclusion is that it saves the system significant amounts of money," Morgan said.
Dr. Michael Koch, chairman of the department of urology at the Indiana University School of Medicine, has only had about two of 3,000 to 4,000 of his prostatectomy patients turn out not to have cancer - and both of those had precancerous changes.
To prevent mistakes, the IU lab will not run the same type of biopsy twice in a row to make sure that no tissue remaining from the previous test can contaminate the next sample. But some commercial labs specialize in one type of biopsy.
"If you have a lab that only processes prostate specimens, it makes sense to do this," Koch said. "I think, if it was your own biopsy, if there was a 2 to 3 percent chance it's wrong, you would be willing to pay a little more to make sure there was no error."
Morgan said Strand finds an error about every week, ranging from contaminated samples or samples that simply get switched.
When an error is detected, Strand notifies doctors immediately so they can stop any planned therapy until the error is resolved.
"It doesn't matter how meticulous you are . you just cannot reduce the error rate to zero," Morgan said. "This is a safety net that allows you to appreciate the errors that do make it through all of those quality improvement steps and recognize them before a patient is harmed."
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Information from: The Indianapolis Star, http://www.indystar.com
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