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University of Birmingham, Nonacus to Develop Urine Cancer Liquid Biopsy Assay

NEW YORK – Nonacus and the University of Birmingham in the UK said on Thursday that they have partnered to develop a noninvasive liquid biopsy assay for bladder cancer detection.

The partners aim to offer the assay, which uses Nonacus' liquid biopsy platform and a panel of biomarkers validated by the university, by mid-2022.

Researchers at the university's Bladder Cancer Research Centre previously used deep sequencing to identify mutations present in the majority of urothelial bladder cancers. The work involved sequencing 23 genes from tumor samples gathered from 956 newly diagnosed, treatment-naïve patients.

Identifying 451 unique mutations in more than 96 percent of tumors, the team also spotted the mutations in urine samples collected at the same time as tumor collection.

The researchers, therefore, believe that combining the unique molecular identifier mutation panel with Nonacus' Cell3 Target enrichment system which converts DNA into libraries for sequencing purposes will offer a much more sensitive test than existing PCR-based approaches. The group expects the final project will include access to bioinformatics software to further support analysis.

Nonacus said the test will provide high sensitivity for all stages and grades of urothelial bladder cancer, and added that it will be available worldwide to laboratories, hospitals, and clinics.

"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," Chris Sale, CEO of Nonacus, said in a statement.

Financial details of the agreement were not disclosed.

"While blood visible in the urine should always be investigated, over 80 percent of people who have a cystoscopy at a hematuria clinic are diagnosed with non-malignant conditions or have no abnormality. Unfortunately, the remaining 20 percent will need a further invasive procedure to confirm diagnosis," Rik Bryan, director of the Bladder Cancer Research Centre, added. "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."

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