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A highly sensitive genetic test that can give a warning of a potential high-grade bladder cancer based on analysis of a urine sample is now available to patients to buy online in the UK.
The BCA-1 Test is specific to bladder cancer and for patients already diagnosed to help monitor their disease by sending a urine sample to be analysed and returned with a specialist doctor’s report.
Seven out of 10 cases of bladder cancer are diagnosed at an early stage when it is non muscle-invasive (before it has penetrated the bladder wall). At this stage, treatment is often effective, but bladder cancer has a high chance of recurring or progressing to a more aggressive stage.
For patients, this means ongoing follow-ups, including invasive tests such as cystoscopy where a flexible tube is passed through the urethra and into the bladder to remove cells for biopsy.
The BCA-1 Test, which looks for abnormal genetic alterations in cells that are shed from the bladder wall, offers new hope to the 10,000 people diagnosed each year in the UK. Cancers occur when mutations arise in the genetic code causing cells to behave in an uncontrolled way.
The BCA-1 Test is able to predict with 95% sensitivity whether a cystoscopy will return positive and, if so, it can reveal the whether it is likely to be high or low grade bladder cancer. This level of analysis is all possible without having invasive or unnecessary surgery.
The BCA-1 Test looks at 27 specific structural changes, which are deletions or duplications in the DNA at certain points along each chromosome – known as genetic markers.
These 27 genetic markers are known to be present in bladder cancer cells and enables the correlation of genomic activity with the WHO guidelines on high- and low-grade bladder cancer. So, as well as the likelihood of recurrence the test can also tell, with some certainty, whether or not the cancer is aggressive (requiring more urgent attention).
In repetitive studies, the BCA-1 Test has demonstrated an overall sensitivity of 95% to detect bladder cancer. This compares to the gold standard for similar medical tests of 90% and means that it is unlikely to miss a bladder cancer or its recurrence and is able to differentiate potential high-grade tumours that would need action.
Importantly, for the 50% of people with bladder cancer who need annual follow-ups for five years or more, it can also help doctors to determine the best course of action or if the cancer has been treated effectively.
The BCA-1 Test costs £299 and is available from www.bca-1.com
ArrayGenomics believe the BCA-1 Test can be used as an adjunct to other tests to take away some of the uncertainty and discomfort of bladder cancer.
By providing actionable data, the BCA-1 Test can give unique insights into what might happen in the next few months and help people make decisions about their cancer journey, including possible treatment options.
The fact that it is non-invasive means patients can use the test without risk of side effects.
The BCA-1 Test represents a decade of research by ArrayGenomics and a group of European academics and urologists. They developed the test to see if it was possible to use techniques for genomic profiling to analyse the DNA of bladder cancer cells and provide patients and doctors with additional information about their bladder cancer.
Prof. Olivier Cussenot, Head of Surgery Oncology & Urology at Hospital Tenon (Paris, France) Cussenot, helped to develop the test and has now used it with patients for more than five years for research purposes to validate the test.
He said, “The medical profession has long been asking for a urine-based test for monitoring bladder cancer. A genetic test gives us a new level of insight because it can ‘see’ changes in DNA that may not yet be visible under a microscope. It’s an early warning for these patients – and it can be done without any discomfort or a hospital visit.”
ArrayGenomics have launched their test via an online platform. Patients order a kit and post back a urine sample. A few days later they receive a report telling them which, if any, genetic markers are revealed and reports an increased risk of recurrence and the level of activity observed together with a narrative from a specialist consultant.
Alternatively, they will be told if there is no genomic activity present – although they stress that the test should not replace ongoing hospital follow-ups.
The company is looking to continue to work with clinicians and clinics to make the test more widely available to patients and enabling further research.
Said Steven Jones of Array Genomics, “By analysing and sharing information about the 27 genetic markers associated with bladder cancer, we hope to support the scientific community to advance their ability to manage cancers using knowledge of the genomic changes that occur in cancerous cells.
Working with urologists, geneticists and pathologists for such a long time we have focused and created the BCA-1 test with their expertise at the core of our technology. This test provides significant value for medical professional but also for patients of bladder cancer.”
ArrayGenomics is also working on tests for the detection of kidney and prostate cancer.
The BCA-1 test has acquired CE-IVD marking in the UK in 2019. Registered with MHRA.