Life Sciences

Life Sciences

BladderCa Urine Test - EI-BLA: 2-gene biomarker panel for early detection of bladder cancer from urine



Ref.-Nr. 3160

The ECRG4 and ITIH5 (EI) gene promoter methylation has been identified as a novel objective biomarker panel for the diagnosis of bladder cancer (BLA) at an early stage (EI-BLA). This 2-gene panel detects bladder cancer with a specificity of 100% combined with a sensitivity of 84%. The biomarker panel is detectable in the  urine sediment using standard analytical techniques (e.g. pyrosequencing as a reliable and fast method to quantify CpG methylation).

Due to the easy access to the samples the inventive method is cost-effective and convenient for the patients.

Commercial Opportunities

Urinary bladder carcinoma is one of the most common cancers in human and the most expensive tumour in the US and Europe  due to the need for lifelong surveillance. Cystoscopy, “the gold standard” for diagnostic evaluation of bladder cancer, is an invasive, time-consuming and cost-intensive method that is little accepted by the patients. Voided urine cytology as non-invasive method has been utilized as an additional diagnostic tool and screening test. However, the limitations of this method are found both in its comparative low sensitivity and its low objectiveness as it is dependent on the evaluation and experience of the observer.

Due to the shortcomings of cystoscopy and cytology, there has been great interest in identifying tumour biomarkers detectable in the urine that could provide a more sensitive and objective test for the early detection of bladder cancer and its recurrence. However, none of the currently available urine markers that are approved by the FDA can be recommended without limitations for clinical use. EI-BLA, our inventive 2-gene biomarker panel is more specific than any of these detection systems and thus constitutes a promising new approach for early bladder cancer detection.

Developmental Status

The ECRG4 and ITIH5 gene promoter methylation has been identified as a novel biomarker panel for the early detection of bladder cancer. Its strong diagnostic potential has been demonstrated in a larger cohort of urine samples from bladder cancer vs. healthy controls. A further screening trial using independent (multicenter) urine samples has been initiated.

Competitive Advantages

  • EI-BLA, a novel biomarker panel for the early detection of bladder cancer from Urine
  • Level of promoter methylation can be easily assessed with robust standard techniques
  • Specificity of 100%, sensitivity of 84%
  • Non-invasive approach for early bladder cancer detection

Current Patent Status

In case of interest we are pleased to inform you about the patent status.

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