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Better diagnosis for better care 

Bladder cancer is the 5th most prevalent cancer worldwide and has a 70% rate of recurrence, making it a considerable strain to healthcare systems.

The most common causes are smoking, pollution, solvent exposure and  genomic heritage. It has no respect for gender and it has become a major issue for emerging markets

How is Bladder Cancer currently monitored? 

The standard method for detection and surveillance of bladder cancer is cystoscopy in conjunction with urine cytology. Although cystoscopy is relatively sensitive, it is also expensive and invasive. Conversely, urine cytology, while non-invasive and highly specific, yields poor sensitivity. 

A recent study by the European Association of Urology (Larre, et. al. – see bottom of page) identified a number of genomic aberrations that, when incorporated into a comparative genomic hybridization (CGH) microarray assay, showed excellent prognostic and predictive performance.

 

ArrayGenomics has worked with researchers to develop an oligonucleotide microarray assay that provides the most clinically relevant profile of a patient’s bladder cancer available on the market today.

Advantages of the ArrayGenomics BCA Test 

  1. Ease of use: The ArrayGenomics BCA test requires only a small flask of urine.
     

  2. Reliability:  Results from the BCA test surpass results in sensitivity and specificity provided by cystoscopy and/or biopsy.
     

  3. Security: With its 27 DNA markers, the BCA test enables clinicians to clearly identify the grade of the cancer and to choose the best course of treatment.
     

  4. Patient care: The BCA test is a non-invasive procedure for the patient. 40% of the patients opt out of regular testing by cystoscopy
     

  5. Scalability: Cystoscopies need to be done regularly and often to ensure reliable results
     

  6. Time & Cost: The cost of multiple cystoscopies is much greater, and takes much longer, than the ArrayGenomics BCA test.

How the ArrayGenomics BCA test works

  1. The urine sample is collected in a tube provided by ArrayGenomics 
     

  2. DNA is extracted from the urine sample 
     

  3. The extracted DNA is positioned onto the micro-array provided by ArrayGenomics (as shown below)







     

  4. The microarray is screened for chromosomal aberrations using ArrayGenomics' patented markers.*

    * The BCA test from ArrayGenomics has 27 markers They have been chosen to cover all known genomic zones implicated in bladder cancer.

Clinical Results 

Key results of a November 2013 clinical study on 164 patients led by Prof. O. Cussenot:
(available here: http://www.ncbi.nlm.nih.gov/pubmed/24196429)

 

100%

Sensitivity for High Grade cancers
BCA detected all High Grade cancers

95%

Overall sensitivity

BCA found all clinically important bladder cancers.

75%

Specificity

98.6%

Negative cases identified correctly 

(Negative predictive value)
If a patient is tested negative with BCA then the clinician does not need to carry out a cystoscopy

BCA vs Cystoscopy

 

Half of the cystoscopies in BCA trial were found to have been unnecessary. Of 95 patients with a negative cystoscopy, 49 (51%) were found to be negative with BCA. If BCA had been used in the first instance, these patients would have been identified as not needing a cystoscopy, thereby saving costs and improving patient care.


If BCA was used on regular basis, considerable savings could be made by health providers.

BCA detects bladder cancer earlier than cystoscopy. 14 patients with a negative cystoscopy. were found positive with BCA and these patients were subsequently found positive in follow-up cystoscopies.

 

In this study the BCA test has high clinical utility, eliminates unnecessary cystoscopies and clearly shows it has higher and earlier sensitivity than cystoscopy. It improves patient care and has the potential to reduce healthcare costs.

Scientific Studies

Title                                                                                            Authors                                 Year                   Link

Targeted Copy Number Variations Profiling of Non Muscle Invasive Bladder Urothelial Carcinoma Using BCA-1 Test on Urines Predicts High Grade Tumors

Lunelli, L, Léon, P. Cancel Tassin, G, Sighar, K, Compérat, E, Hugonin, S, Audouin, M, Lacave, R. Cussenot, O.

2017

Correlation of genetic and cytogenetic alterations in pathological aggressiveness urothelial carcinoma of the bladder: Performance of BCA-1, a mini-array comparative genomic hybridisation-based test.

Léon, P, Cancel Tassin, G, Sighar, K, Compérat, E, Gaffory, C, Ondet, V, Hugonin, S, Audouin, M, Doizi, S, Traxer, O, Ciofu, C, Rouprêt, M, Lacave, R, Cussenot, O.

2017

Detection of specific chromosomal aberrations in urine using BCA-1 (oligo-CGH-array) enhances diagnostic sensitivity and predicts the aggressiveness of non-muscle-invasive bladder transitional cell carcinoma.

Cussenot, O, Sighar, K, Mohammed, M, Hugonin, S, Ondet, V, Larre, S, Lacave, R, Roupret, M, Cancel-Tassin, G.​

2014

Diagnostic, staging, and grading of urothelial carcinomas from urine: performance of BCA-1, a mini-array comparative genomic hybridisation-based test.

Larré, S, Camparo, P, Comperat, E, Gil Diez De Medina, S, Traxer, O, Roupret, M, Sebe, P, Cancel-Tassin, G, Sighar, K, Lozach, F, Cussenot, O.

2010

A new study of more than 500 patients has been completed and results are to be published very shortly​