Nonacus, a liquid biopsy provider collaborated with the University of Birmingham to develop a non-invasive test for bladder cancer and it is expected to be available in mid-2022. The test will be done using Nonacus’ liquid biopsy technology along with a panel of biomarkers to diagnose disease from urine samples. Yearly, more than 100,000 people are referred to hospitals in the UK to diagnose bladder cancer, mostly after they have passed blood in their urine (haematuria). Cystoscopy is the first stage of investigation which requires inserting a camera into the bladder. About 12% are subsequently diagnosed with bladder cancer, mostly after a second invasive procedure to extract biopsy.
The director of the Bladder Cancer Research Center, Dr. Bryan said: “While blood visible in the urine has to be investigated, more than 80% of people who have done a cystoscopy are diagnosed with non-malignant conditions or do not have an abnormality. Unfortunately, the other 20% need to do further invasive procedures of investigation to confirm their diagnosis. What is required to get a good diagnosis is a highly specific and sensitive, non-invasive test that can provide quick results for those who need a biopsy and those who do not, and doing a urine test is a good place to start. The liquid biopsy is attractive, however, to achieve accurate results, a highly sensitive analytical technique is required.”
Researchers, at the University, started their work knowing that Nonacus has pioneered commercial non-invasive prenatal tests to identify low levels of fetal DNA in maternal blood samples. The researchers made use of ‘deep sequencing’ of tumor DNA to identify mutations that are present in most urothelial bladder cancers (UBCs). The research work was financed by an MRC Confidence in Concept and Cancer Research UK grant, which involved sequencing 23 genes from tumor samples that were collected from 956 newly diagnosed, treatment-naïve patients. This deep sequencing of genes identified 451 unique mutations that were present in over 96% of tumors.
The mutations were identifiable in urine samples collected at the same time as tumor sampling. Mutated DNA in a urine sample can be extracted from cancer cells shed into the urine from the lining of the urinary tract or can be found as cell-free DNA fragments. However, extracting DNA from the cancer cells provides more reliable amounts of DNA for the test, especially when only small volumes of urine may be available. Coupling the mutation panel with the molecular identifiers and the target capture technology provided by the Nonacus Cell3 Target can provide a more sensitive test than the PCR-based approach.
The main research also determined the influence mutations has on time to recurrence, Progression of cancer, and the general and disease-specific survival in patients that have non-muscle-invasive bladder cancer (NMIBC) and disease-specific survival in patients with muscle-invasive bladder cancer (MIBC) ringing about the possibility of using the test to stratify patients based on risk.
