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Medical Device Daily Staff Writer

It is widely known that breast cancer is the second most common cancer among women in the U.S. However, many patients and physicians are unaware that the process of collecting and evaluating the biopsy specimens used to render these cancer diagnoses involves nearly 20 steps and several medical professionals working in different locations. With such a complex process executed at a large scale, the risk of patient misidentification, specimen transposition or foreign cell contamination occurring in clinical or anatomical pathology is an ongoing concern. If left undetected, these mistakes can lead to misdiagnoses and adverse patient outcomes.

A firm that mostly specializes in forensics is using DNA profiling to eliminate errors due to the misidentification of biopsy samples.

Strand Diagnostics (Indianapolis) has launched its know error system for breast biopsies that compares the DNA profile of the breast biopsy specimen to a reference sample taken via cheek swab.

"We're by trade a forensic crime lab, so the history of our company is deeply rooted in forensics," Ken Cerney, president of Strand Diagnostics," told Medical Device Daily. "The company started as Strand Analytical in 2004. Recently in March we changed the company to Strand Diagnostics. Bottom line is we combined the medical component with the forensics."

The know error system for breast biopsies compares the DNA profile of the breast biopsy specimen to a reference sample taken via cheek swab.

'What we've discovered is that one out of 100 - about 1% of the time it's a non match and it runs the risk of not being that patient," he said.

The company said that this simple process safeguards patients from misidentification errors that may occur during the complex diagnostic testing cycle for cancer.

"At the time of collection we take a cheap swab with patient consent and it's ordered by a physician," Cerney said. "We take a cheap swab of a patient and we hold that at our forensic lab. When and only if physicians diagnose cancer, then we ask for a cut of the same tissue they diagnose and we match it up with the tissue collected from the original swab."

He added, "So before they do surgery, before they do a mastectomy, before they do a radical procedure on a prostate; before they do any type of radical procedure on that patient we know for sure that tissue they're using to diagnose the patient is the same one and it matches up for the patient with cancer."

The system uses patient-specific bar coding and forensic chain-of-custody principles for the purpose of reducing errors, and DNA testing (also known as DNA Specimen Provenance Assignment testing) for the purpose of identifying errors before adverse patient outcomes occur.

"The possibility of a misidentification of a patient's biopsy results is nothing short of catastrophic—patients are being treated for cancer that does not exist. Mastectomies, chemotherapy and radiation occurring on non-diseased tissues is completely unnecessary. In addition, potentially life-saving treatment may be delayed for the complementary patient with the false negative diagnosis," said Andrew Kenler, MD, a surgeon at the Norma F. Pfriem Breast Care Center (Fairfield, Connecticut). "For patients who are already faced with the prospect of a cancer diagnosis, DNA confirmation can provide a peace of mind for the patient and provider—an assurance that every patient deserves."

Strand Diagnostics transition into the medical device field was a bit daunting and Cerney pointed out some of the differences between the two. While in forensics the company looked at rape kits and analyzed evidence from crime scenes the switch to medical devices was more about clinical evaluation of patients.

"You got a match on the forensic side and you're going to jail," Cerney said. "You go on our medical side and get a match and the cancer you've been diagnosed with is yours and you can get past the do I need a third and fourth opinion. We know that it's your cancer. We can't tell the patient that it is cancer, but we can tell whether or not the cancer results belong to the patient, which is pretty powerful for them."

The company said that in the future the test could lend itself to other disease states and noted that this was a powerful step in the advancement of personalized medicine.

"I think the future is here in terms of personalized medicine . . . on gene expression and really understanding what that cancer means and how to apply appropriate drugs to that," he said. "Where we fit in is that we're the person in personalized medicine. We're identifying if the diagnosed tissue matches the patient. There's no reason to drug development; there's no reason to apply the right drug to the wrong person because it's not their cancer. It could do harm for that patient if its given to the wrong patient."

Omar Ford; 404-262-5546

Published  September 25, 2012

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