The BCA-1 Test - Healthcare Professionals

We welcome enquiries from clinicians who wish to explore the advantages of the BCA-1 Test for their patients, or who are interested to join our expert review panel. Contact us.

Security:
With its 27 DNA markers, the BCA-1 Test helps clinicians to identify the grade of the cancer which could help inform an appropriate course of treatment.

Reliability:
Results from the BCA-1 Test have shown equivalent levels of sensitivity and specificity as provided by cystoscopy and/or biopsy, in particular for high grade tumours.

Ease of use:
The ArrayGenomics BCA-1 Test requires only a specimen of urine.

Ease of implementation:
The BCA-1 Test uses Comparative Genomic Hybridisation technology (CGH) and a laser scanner to analyse the bladder cancer test result.

Patient care:
The BCA-1 Test is a painless and non-invasive procedure for the patient.

Scalability, time and cost:
Cystoscopies in diagnosed patients need to be repeated regularly and often to ensure reliable results.

The cost of multiple cystoscopies is high and takes much longer than the ArrayGenomics BCA-1 Test. The BCA-1 Test should be used as an adjunct to cystoscopies to enable patients and doctors to regularly follow the genomic profile of existing bladder cancer.

Health economics:
The BCA-1 Test could represent significant savings for health authorities.

 

 

The BCA-1 Test is an oligonucleotide microarray assay that meets many of the requirements of a test for bladder cancer

After 10 years in development with a team of top level European researchers, ArrayGenomics is now offering a patented oligonucleotide microarray assay that provides the most clinically relevant profile of a patient’s bladder cancer available on the market today.1

The BCA-1 Test from ArrayGenomics has 27 markers. They have been chosen to cover all known genomic zones implicated in bladder cancer.2

 

 

Specificity and Sensitivity of the BCA-1 Test

Studies to assess the diagnostic performance of the BCA-1 Test based on cytogenetic abnormalities to diagnose, stage and grade BUC from urine showed a high diagnostic performance.3

BCA-1 Test overall sensitivity 95%
BCA-1 Test specificity 86%
BCA-1 Test negative predictive value 98.6%

A study published in European Urology identified a number of genomic aberrations that, when incorporated into a comparative genomic hybridization (CGH) microarray assay, showed excellent prognostic and predictive performance.3

 

 

BCA-1 Test superior prognosis for high grade tumours

Studies have shown that the BCA-1 Test is able to identify patients at high-risk, harbouring a high grade disease. From analysis of 164 urine samples, researchers were able to differentiate B-TCC from non-malignant conditions with an accuracy of 100% for patients without history of bladder cancer. For follow-up of B-TCC (Bladder Transitional Cell Carcinoma), 100% of high-grade tumours were diagnosed, and the sensitivity to predict positive cystoscopy was 95%. 4

"My experience of BCA-1 Test across more than 700 patients is its ability to detect all high grade cancers and, in many cases, before they could be identified during cystoscopy.”
Professor Olivier Cussenot, M.D., Ph.D.
Professor at the Pierre & Marie Curie Faculty of Medicine, Sorbonne University.

A further analysis of urinary DNA in 50 patients with negative or non-informative urine cytology demonstrated that the BCA-1 Test was able to correlate results to grade and stage of bladder cancer and was therefore a reliable predictor of tumours with a high risk of recurrence and progression.1

 

 

The BCA-1 Test has been shown to detect bladder cancer earlier than cystoscopy

The BCA-1 Test detects bladder cancer earlier than cystoscopy. 14 patients with a negative cystoscopy result were found to have a positive BCA-1 test result and further were subsequently found to be positive in follow-up cystoscopy.5

 

 

The BCA-1 Test can improve patient quality of life

The test is non-invasive and simple to administer. For patients living with bladder cancer there is an obvious benefit in them being able to replace some of the required surveillance interventions (e.g. cystoscopy) with this test.

Our vision is to work with health providers to enhance care pathways for bladder cancer. The BCA-1 Test can provide fast, pain-free, accurate monitoring and prognosis at a given point in time. This provides peace of mind and the ability to make plans around work or family based on the outlook.

It may also offer opportunities for targeted or alternative interventions that offer improved outcomes over the longer term.

 

 

The BCA-1 Test has the potential to reduce healthcare costs

If the BCA-1 Test was used on a regular basis, material savings could be made by health providers.

There is a significant cost associated with investigating haematuria, in large part due to the cost of the cystoscopy procedure. It has been estimated in the UK that investigating haematuria patients, found not to have bladder cancer, contributes to one third of the total cost of managing patients with non-muscle-invasive bladder cancer (estimated to be £100 million in 2008) Therefore, there is a strong health economic and clinical need for a comparatively inexpensive, high performance, monitoring test.6

The BCA-1 Test is readily automated and has various potential clinical applications that would require further investigation. It may be of interest in the surveillance following BUC (bladder urothelial carcinoma) treatment or for patients investigated for haematuria. It may also be able to replace cytology and clarify grading in intermediate-grade cases. This may also be of interest for upper urinary tract urothelial carcinoma (UUT-UC), which usually harbours similar genetic profiles to BUC. It may help to differentiate candidates for conservative treatment using ureterorenoscopy and laser vaporisation of UUT-UC rather than nephroureterectomy, especially for those patients having renal impairment.3

 

 

References

  • 1. Lunelli, L, et al. Targeted Copy Number Variations Profiling of Non Muscle Invasive Bladder Urothelial Carcinoma Using BCA-1 Test on Urines Predicts High Grade Tumors. Urol Res Ther J. 2017; 1(1): 113.
  • 2. Data on file.
  • 3. Larré S, et al. Diagnostic, staging, and grading of urothelial carcinomas from urine: performance of BCA-1, a mini-array comparative genomic hybridisation-based test. Eur Urol. 2011; 59(2):250-7
  • 4. Cussenot O, et al. 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. World J Urol. 2014; 32(2):551-7
  • 5. Data on file.
  • 6. Whelan P, et al. Economic burden of bladder cancer in the UK. BJU International. 2008;101(suppl.5):35