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In an effort to reduce the number of labeling errors that may lead to the switching of biopsy tissue samples, a number of error reduction systems have been suggested and/or utilized in addition to quality assurance processes already in place.  Detecting these errors is exceedingly important since the switching of a biopsy result may lead to serious consequences for the patients involved, such as the unnecessary treatment of a cancer-free patient or no treatment for a patient who has cancer and needs immediate treatment.

After receiving the life changing diagnosis of cancer, some physicians may encourage a patient to seek a second opinion.  Friends and family would most certainly insist on this; perhaps even go to the lengths of seeking out an expert in the field or a world-class hospital that specializes in a particular type of cancer.

In most cases, the purpose of the second "opinion" is to verify the cancer diagnosis and more importantly, to validate the treatment plan suggested by the first physician.  For instance, if a patient seeks the second opinion of a physician taking part in a clinical study, the approach to treatment may be drastically different.  After gaining both opinions, it is then up to the patient to compare both opinions and determine which approach is right for him.

However, what if the problem to be found had nothing to do with the diagnosis but rather the fact that the diagnosis was based on the wrong patient's biopsy results?  In other words, a cancer free patient's results were switched with the results of a patient who had cancer (click here to read about such a switching error).  In this case, a second opinion (or third or fourth) would do nothing to protect the patient.  Unless a second biopsy was ordered by the physician offering the second opinion, this switching error would very likely remain undetected. At that point, a cancer free patient may have undergone an unneccessary surgery such as a double masectomy or prostatecomy.

The know error® system, introduced in 2009 by Diagnostic ID, LLC, employs a DNA matching technology that provides DNA confirmation of a positive biopsy result.  With the know error® system in place, patients and physicians alike are ensured that the first opinion and any given thereafter are based on the right biopsy results. 

For more information about the know error® system, please visit our website www.knowerror.com. 

A new video overview of the know error® system has been created and can be viewed online at www.knowerror.com/video.  The video illustrates the three key elements that make up the know error® system process:  swab. sample. dna match.

swab.  Before a biopsy procedure, a reference sample of a patient's DNA is taken by gently swabbing the inside of his cheek. The swab is sent to an independent forensic DNA lab with the patient's unique patient ID.

sample.  The unique bar code is attached to the patient's file along with all other materials in the biopsy kit.

dna match.  When a patient's pathology result is positive for cancer, all positive specimens are sent to the DNA lab for DNA matching with the reference sample.

By confirming a DNA match, patients and physicians can confidently proceed with treatment options based on the patient's lab results.  When adopted by pathology labs and their referring physicians, the know error® system can reduce Specimen Provenance Complications (SPC) and assure that no adverse patient outcomes will occur from undetected complications.  

The know error® system, introduced in 2009 by Diagnostic ID, LLC, brings new levels of safety and accuracy to the biopsy evaluation process. Through DNA Specimen Provenance Assignment (DSPA) and bar code technology, this innovative system virtually eliminates the possibility of diagnostic mistakes due to SPC.

For more information about the know error® system, please visit our website www.knowerror.com.

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