A non-invasive test for bladder cancer has been developed by Nonacus and the University of Birmingham.
The test, which is expected to be available by mid-2022, will use highly sensitive liquid biopsy technology developed by Nonacus, and a panel of biomarkers validated by Dr Rik Bryan and Dr Douglas Ward from the University’s Bladder Cancer Research Centre, to diagnose the disease from urine samples.
Bladder cancer is the seventh most common cancer in the developed world, and in the UK, over 100,000 people a year are referred to hospital clinics that investigate for bladder cancer. The first stage of investigation is usually cystoscopy, which involves inserting a camera into the bladder.
Of these 100,000 patients, around 12 per cent are subsequently diagnosed with bladder cancer, normally after a second invasive procedure to extract a biopsy.
“While blood visible in the urine should always be investigated, over 80 per cent of people who have a cystoscopy at a haematuria clinic are diagnosed with non-malignant conditions or have no abnormality,” says Dr Bryan.
“Unfortunately, the remaining 20 per cent will need a further invasive procedure to confirm diagnosis. What is required is a highly sensitive and specific, non-invasive test that can rapidly determine those who need a biopsy and those who do not, and a urine test is the obvious place to start.”
Researchers at the University started their work in the knowledge that Nonacus had already successfully pioneered commercial non-invasive prenatal tests to identify low-levels of foetal DNA in maternal blood samples.
Moreover, the company was developing methods to allow confident and sensitive calling of mutations from as little as 10ng of DNA.
The researchers used ‘deep sequencing’ of tumour DNA to identify mutations that are present in the majority of urothelial bladder cancers (UBCs). Their work, which was funded by Cancer Research UK and an MRC Confidence in Concept grant, involved sequencing 23 genes from tumour samples collected from 956 newly diagnosed, treatment-naïve patients.
This deep sequencing of genes identified 451 unique mutations that were present in over 96 per cent of tumours. The researchers also demonstrated that these mutations were identifiable in urine samples collected at the same time as tumour sampling.
Nonacus intends to launch the new bladder cancer test within 12 months, and the final product will include access to bioinformatics software to help with analysis. The company expects the test will provide high sensitivity for all stages and grades of disease, and will ensure the test is available worldwide to laboratories, hospitals and clinics.
Chris Sale, CEO of Nonacus, says: “We expect this partnership to deliver better care and outcomes for patients by reducing the number of invasive procedures, providing earlier diagnosis and speeding up access to treatment for people with bladder cancer.”
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