New Patient Safety Study Reveals Misdiagnosis of 1 in Every 200 Prostate Biopsy Patients, Wasting Over $880 Million in Unnecessary Healthcare Expenditures Annually

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Study statistics show the economic burden on the healthcare industry related to cancer misdiagnosis due to specimen contamination and switching errors of prostate biopsies. Strand Diagnostics provides a diagnostic test which improves patient safety and the quality of care while simultaneously reducing healthcare costs.

What patients, physicians, and payers really need to know isn’t how many undetected provenance errors occur, but how many actually result in patient harm. —Dr. Kirk Wojno

During this National Patient Safety Week, Strand Diagnostics announces the publication of a seminal study exploring the important economic and patient safety consequences of specimen provenance complications (“SPCs”) in the prostate biopsy setting. The new study to be published in the April issue of The Journal of Urology​ concludes that an average of at least 1.13 of every 200 prostate biopsy patients is misdiagnosed due to their biopsy specimens being switched with or contaminated by those of another patient.    

“We know that specimen transposition or contamination occurs in up to 3.5% of biopsy cases in some settings, and that no laboratory is immune to these complications. But the impact of these events on patient care hasn’t been well studied until now,” said Dr. Kirk Wojno, a practicing pathologist and one of the study’s authors. “A specimen switch between two patients with identical cancer, for example, wouldn’t change either patient’s treatment. And extraneous tissue contamination is often obvious under a microscope, presenting little diagnostic difficulty or risk of misdiagnosis. What patients, physicians, and payers really need to know isn’t how many undetected provenance errors occur, but how many actually result in patient harm. This study provides the first rigorous measurement of that problem.”    

To model the economic burden of clinically meaningful SPCs, the authors performed a comprehensive systematic review of previously published studies measuring the frequency and distribution of provenance error rates, positive vs negative cancer diagnoses, extraneous tissue identification, and various treatment modalities and cost. The resulting model predicts that among 806,251 prostate biopsy procedures performed annually in the United States, approximately 2.52% (20,322 cases) involve a specimen switch or contamination. Up to 15,752 of those cases were presumed to have no clinical consequence, leaving 4,570 patients (0.57% of all biopsies) who receive either a false-positive or false-negative diagnosis each year. Depending on patients’ age and other factors, false-positives may result in unnecessary treatment such as radiation or radical prostatectomy. False-negatives can significantly delay treatment, allowing the undetected cancer to progress to a more advanced stage that is more dangerous, difficult, and expensive to treat. Besides the life-changing impact of unnecessary or delayed treatment on patients, the study reports that these diagnostic errors also pose a significant economic burden on society. The economic impact of wasted medical treatment, reduced quality of life experienced by misdiagnosed patients, and avoidable malpractice expenses combine to at least $3,776 per each new prostate cancer diagnosis according to the report.

It is important to note that this study examined only the prostate biopsy setting. Millions of additional biopsies are performed each year to diagnose breast, colon, lung, and other cancers, all of which are subjected to the same laboratory workflow as prostate specimens. Even more concerning are the multitude of genetic tests which are now routinely performed on these same tissue specimens. “Because genetic testing does not involve microscopic evaluation, there is no opportunity to visually rule-out specimen contamination, implying that the rate of misdiagnosis among genetic tests may be even higher than in histopathology,” added Dr. Wojno.

Given the study’s projected 2.5% rate of SPCs nationally, patients and physicians should recognize that any time a tissue specimen is collected and sent out for histopathology or genetic examination, there is significant risk of that specimen being compromised at some point during the complex handling process – even when best practices are followed meticulously at every step. The inevitability of provenance errors isn’t a reflection of poor quality assurance standards, it is the intrinsic reality of manipulating millions of tiny raw tissue specimens by hand. Because no quality assurance program can reduce the error rate to zero, the key to patient safety is detecting errors before patients are harmed by unnecessary or delayed treatment.

Many physicians now believe the only way to know for certain that the correct diagnosis has been attributed to a patient is to match the patient’s unique genetic “fingerprint” to the diagnostic tissue before rendering treatment. Several laboratories now offer a genetic test known as the DNA Specimen Provenance Assay, or “DSPA” for precisely this purpose, and in 2013 the American Medical Association (AMA) established a common procedural terminology (“CPT”) code to facilitate reimbursement for DSPA testing by third-party payers.

According to Travis Morgan, CFO of Strand Diagnostics and study co-author, “Most insurance carriers currently cover the cost of DSPA testing, ensuring that beneficiaries receive the most accurate cancer diagnosis and treatment available. This study is important because it demonstrates to all payers and accountable care organizations that the increased accuracy of a diagnosis which includes DSPA more than pays for the cost of the testing. DSPA is a diagnostic test which improves patient safety and quality of care while simultaneously reducing healthcare costs – the holy grail in today’s healthcare environment. Based on these data, payers should not only continue to reimburse for DSPA testing, they should insist on DSPA concordance as a prerequisite to any invasive or toxic therapy decision that involves a biopsy.”

The full study titled The Clinical and Economic Implications of Specimen Provenance Complications in Diagnostic Prostate Biopsies will appear in the April print edition of the Journal of Urology, and can be accessed immediately online at © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

About Strand Diagnostics
Strand Diagnostics protects the person in personalized medicine® from its high complexity DNA laboratory in Indianapolis, Indiana. Strand is certified to perform medical DNA testing nationally by CLIA and the States of New York, California, and Pennsylvania, and is accredited by FQS-I to perform DNA identification for the Federal Bureau of Investigations. Strand’s patented know error® system is used to protect thousands of surgical biopsy patients each month from diagnostic errors resulting from switched or contaminated tissue specimens. For more information, please visit

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Linda Tuttle
Strand Diagnostics, LLC
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