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.






Immortalized Human Cell Lines

Decisive Diagnostics has 24 immortalized human cell lines that have been fully characterized for a number of polymorphisms in pharmacogenomically important genes.  They have all previously been used to make purified DNA for controls in a variety of assays on a range of platforms.  Examples of types of assays include ADME, aCGH, genotyping, and proficiency testing.


  • Properly consented and anonymized donors
  • Immortalized B-lymphocytes
  • 16 male and 7 female cell lines (gender unknown in 1 cell line)
  • Varied ethnicity


  • 16 distinct CYP2D6 haplotypes.  Metabolism of many drugs including tamoxifen is influenced by CYP2D6 genotype.
  • 4 distinct CYP2C19 haplotypes.  Plavix metabolism can be affected by CYP2C19 genotype.
  • 8 distinct CYP2C9 haplotypes including a CYP2C9 *2/*3-VKORC1 1173 C>T triple heterozygote.  Together with VKORC1, CYP2C9 genotype influences warfarin dosing.
  • 8 distinct VKORC1 haplotypes including a VKORC1 1173 C>T-CYP2C9 *2/*3 triple heterozygote.  Together with CYP2C9, VKORC1 genotype influences warafarin dosing.
  • 4 distinct UGT1A1 haplotypes.  Irinotecan metabolism is influenced by UGT1A1 genotype.
  • 6 distinct MTHFR haplotypes.  Certain MTHFR genotypes may be associated with risk of miscarriages.
  • 8 distinct NAT2 haplotypes.  Many drugs are metabolically activated by NAT2 which also plays a role in detoxifying chemicals in the body.

Additional Licensing Opportunities

Sequencing, Antibodies, Colon Cancer, Dual Labeled Nucleotides

Decisive Diagnostics has the rights to a large body of intellectual property through its parent company Catalyst Assets.

Whether your research involves sequencing or antibodies, we may be able to offer you licensing opportunities to our patented technologies and help you further your product development. Ask us about our patented colon cancer research.  In a single assay you can determine both the microsatellite status of the cancer and whether microsatellite unstable (MSI) colon cancers are hereditary or sporadic.

Decisive Diagnostics has rights to novel dual labeled nucleotide designs (patent pending). These nucleotides can have applications in quantitative PCR, sequencing and beyond.