Bladder Cancer Progression Risk Assay

Better guidance for making critical treatment and monitoring decisions in patients with early stage bladder cancer.

Using a key panel of genetic markers, Decisive Diagnostics has developed an assay that can help determine risk of bladder cancer progression in patients with early stage disease.  Bladder Cancer is the fourth most common type of cancer in men and the ninth most prevalent in women in the United States.  More than 60,000 new cases are diagnosed each year.  At present no approved clinically useful markers separating patients with non-muscle invasive bladder cancer by likelihood of progression exist.  Our test will give pathologists and urologists a new valuable tool in understanding which bladder cancer patients are likely to progress and need additional treatment.  Additionally, patients identified by our test as unlikely to progress can avoid unnecessary and invasive monitoring and treatment.

Decisive Diagnostics is looking for partners interested in bringing this important diagnostic test to market.

Bladder cancer is a highly recurrent form of cancer.  80% of patients diagnosed with non-muscle invasive bladder cancer experience a recurrence and 20% of recurrences are progression to muscle invasive cancer (stage T2 or higher).  The combination of the high recurrence rate and the current inability to predict disease course using clinical risk factors, makes bladder cancer the most expensive cancer to treat per capita.  Patients require invasive monitoring (cystoscopy) every 3-6 months for at least 2 years to detect recurrences early.  The Decisive Diagnostics progression risk molecular assay can better guide clinical decisions and ensure patients get the best possible treatment early while avoiding unnecessary procedures.

Progression Risk Molecular Assay:

This assay was developed with scientists at Aros Applied Biotechnology AS in Denmark. The tissue samples came from biopsied tumors in patients with stage Ta or T1 bladder cancer in Denmark, Sweden, England and Spain.

Test results show the likelihood of bladder cancer progression is high:

  • Consider shorter intervals between cystoscopy
  • Consider earlier treatment with intravesical therapy
  • Consider cystectomy earlier

Test results show the likelihood of bladder cancer progression is low:

  • Consider longer intervals between cystoscopy
  • Consider earlier removal from all monitoring


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Dyrskjøt L, Reinert T, Novorodovsky A, et al. Analysis of molecular intra-patient variation and delineation of a prognostic 12-gene signature in non-muscle invasive bladder cancer; technology transfer from microarrays to PCR. British Journal of Cancer (2012), 1-7.

Dyrskjøt L, Zieger K, Real FX, et al. Gene Expression Signatures Predict Outcome in Non-Muscle-Invasive Bladder Carcinoma: A Multicenter Validation Study. Clin Cancer Res 2007 June 15; 13 (12):3545-3551.

Dyrskjøt L, Zieger, K, Kruhoffer, M, et al. A Molecular Signature in Superficial Bladder Carcinoma Predicts Clinical Outcome. Clin Cancer Res 2005; 11:4029-4036. Epub 2005 Jun 01.

Dyrskjøt L, Thykjaer T, Kruhoffer M, Jensen JL, Marcussen N, Hamilton-Dutoit S, Wolf H, Ørntoft TF. Identifying distinct classes of bladder carcinoma using microarrays. Nat Genet. 2003 Jan; 33(1):90-6. Epub 2002 Dec 09.