Pathwork Diagnostics has reported study results that confirming the clinical utility of the Pathwork Tissue of Origin test in diagnosing challenging cancer cases.
The Tissue of Origin assay is the only FDA-cleared, Medicare-covered molecular diagnostic test that performs a gene expression profile of the cancerous tissue and provides objective information to assist physicians in making definitive diagnoses.
The test using the proprietary algorithms, measures the gene expression levels of more than 2,000 genes and compares the gene expression pattern of the patient tumour specimen to that of 15 tissues in the test's database.
The molecular diagnostic test uses a tumour's own genomic information to enable pathologists and oncologists in the diagnosis of challenging cancer cases.
The clinical performance of the test was examined in 43 poorly differentiated and undifferentiated tumour samples, and found that in 95% of cases, the test results were in accordance with the reference diagnosis.
The reference diagnosis was determined based on the clinical correlations and immunohistochemical findings that correlate well with the validated performance of the Tissue of Origin test.
In a previous blinded multisite clinical validation study researchers examined archived, formalin-fixed and paraffin-embedded clinical specimens within the 15 tumour tissues on the Pathwork Tissue of Origin test panel, and found that the results were in agreement with the available diagnosis in 89% of cases.
The test has also been extensively evaluated in multiple independent studies involving more than 1,100 patient specimens, including large validation studies, and a retrospective study of 111 cases from 66 academic and community oncology practices validates the use of the test in management of cancer patients.
Based in California, Pathwork Diagnostics has introduced its proprietary informatics platform to develop and commercialise high-value, medically important diagnostics to help guide cancer care.