Strand Diagnostics Receives Patent on Novel Know Error® DNA Process to Ensure Integrity of Diagnostic Specimens

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The know error system is a novel specimen collection kit combined with a rapid and cost-effective DNA analysis of diagnostic specimens.

Strand Diagnostics, a molecular diagnostics company providing DNA Specimen Provenance Assay (DSPA) testing and forensic DNA testing for crime scene investigations, announced today that the United States Patent and Trademark Office has awarded patent protection for its know error® DSPA system. The know error system ensures that a diagnostic workup (whether via histologic, genomic, or proteomic methods) is based exclusively on cells originating from the correct patient, saving patients the tragic consequences of a mistaken diagnosis and unnecessary treatment, and the healthcare system millions of dollars each year.

Studies have shown that up to 3.5% of diagnostic specimens processed in certain settings are transposed with or contaminated by tissue from the wrong patient, potentially leading to catastrophic diagnostic errors. Such specimen provenance complications (SPCs) persist despite implementation of sophisticated internal controls and best specimen handling practices, and are generally invisible to physicians tasked with rendering a patient’s diagnosis and therapy recommendation. The know error system is used to ensure the integrity of diagnostic specimens by combining a novel specimen collection kit with rapid and cost-effective DNA fingerprinting analysis.

“Each year, thousands of patients with suspected breast and prostate cancer are at risk for misdiagnosis due to specimen provenance complications (SPCs) which are unavoidable in the complex tissue processing workflow. Historically, many of these complications have been invisible to doctors and patients. The know error system has revolutionized expectations of diagnostic accuracy from the surgical biopsy, histopathology, and molecular analysis test cycle by turning those invisible errors into actionable intelligence that prevents costly medical mistakes and misdiagnosis,” said Ted Schenberg, Strand diagnostics CEO and know error co-inventor. “The top 6% of urologists in the U.S. have already adopted the know error system as their diagnostic standard, protecting over 175,000 biopsy patients to date from misdiagnosis due to undetected provenance errors. Issuance of this patent validates the novelty and importance of know error’s approach to enhancing patient safety and diagnostic accuracy, and we look forward to continued adoption among physicians treating prostate, breast, and other cancers.”

Dr. Peter Knapp, a practicing Urologist and co-inventor of the know error system added, “Our mission as physicians is to deliver the right treatment to the right patient at the right time, all of which are predicated on analyzing the right specimens. Given the increasing specificity of diagnosis and treatment in this era of precision medicine, I believe care standards should mandate that the provenance, purity, and identity of every tissue specimen and genome segment being analyzed must be established with absolute certainly prior to rendering treatment to a patient. The know error system provides this diagnostic certainty. If a biopsy specimen is important enough to justify surgical removal, we as physicians have an obligation to take all reasonable measures to ensure the provenance of that specimen throughout the entire test cycle. After all, there is little point in personalizing therapy for the wrong person.”

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 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
+1 8889246779 Ext: 151
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