RT-PCR assay for the diagnosis and surveillance of bladder cancer from urine samples
Description of the assay
UROBEST addresses the need for a non-invasive assay for diagnosis and surveillance of bladder cancer. It is based on a clinically validated signature of ten differentially-expressed genes and displays superior performance (sensitivity 80%; specificity > 93%; AUC 0.91) to other molecular markers in the market. The validation study demonstrated the excellent performance of other three gene signatures of 2, 5 and 12 gene panels.
Bladder cancer is among the five most common malignancies worldwide being responsible for 3% of all cancer deaths in males and 1% in females. If detected early, 5-year survival is high (94%), but >70% of diagnosed patients will have disease recurrence within this period, with 20% progressing to muscle invasive cancer (T2 or higher). High prevalence, survival and recurrence rates combine to make BC is one of the most expensive cancers to treat and monitor.
The gold standard diagnostic tool is combined cystoscopy and cytology which is costly and highly invasive requiring transurethral access and presenting the risk of important complications and discomfort to patients. Because clinical symptoms are not useful in predicting progression, surveillance requires frequent cystoscopies, on average in excess of 13 per patient following initial diagnosis and treatment.
A clear opportunity exists to replace surveillance, and eventually initial examinations with a cost-effective and non-invasive procedure.
Format and clinical performance
The current assay is based on a validated panel of 10 differentially-expressed genes employing RT-qPCR on spontaneous urine samples
Clinical results on a sample of 525 patients after a prospective multinational validation demonstrated that our single non-invasive test yields at least 80% sensitivity and greater than 93% specificity vs. 80% sensitivity and 90% specificity for combined invasive an costlier cystoscopy and cytology . This performance is superior to that of competing biomarkers in the market (NMP22, Alere or BTA Stat, Polymedco) as well as being significantly cheaper than FISH-based tests (UroVysion. Abbott).
Biofina Diagnostics S.L. holds the commercial exploitation rights of the families of patents protecting this diagnostic method. The first patent has been granted in Germany, Belgium, Denmark, Spain, France Ireland, Italy, Netherlands, United Kingdom Sweden, Switzerland, USA and Japan (patent pending in Canada and India). Additional gene-signatures have been claimed in a new EU patent application filed in January 2013 that entered the PCT phase in January 2014 (see Intellectual Property Status below).
Biofina Diagnostics S.L. is currently seeking a licensing/distribution partner that has the capacity to support the company in taking UROBEST into the market.
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- PCT International application number PCT/EP2014/051939 (publication number WO 2014/118334).