The clinical problem of diagnostic errors
Why the know error® system is necessary
The diagnostic testing cycle for cancer can involve up to 18 steps and several medical professionals working in different locations. Each year, it plays a critical role in determining the diagnoses and corresponding treatments of millions of patients.
With such a complex process executed at a large scale, the risk of Specimen Provenance Complications (SPCs) is a serious concern for both physicians and patients. SPCs arise due to instances of biopsy specimen transposition, extraneous/foreign cell contamination and misidentification of cells (patients) that occur in clinical or anatomical pathology. In the case of Biomarker Testing a specimen admixture can cause an incorrect finding and confound the biomarker results. When these SPCs are left undetected, they can lead to serious diagnostic errors and adverse patient outcomes.
When a cancer diagnosis is assigned to the wrong person, the patient with the false-positive diagnosis could receive unnecessary therapy and treatment (chemotherapy, radiation, surgical procedures, etc.) while the patient with the false-negative diagnosis would not receive the care he or she needs in a timely manner.