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Informed Genomics, NHS to Study Use of Urine-Based Bladder Cancer Test

NEW YORK – Genomic testing laboratory Informed Genomics said Wednesday that it has formed a partnership with five UK National Health Service Trusts to compare the performance of the company's bladder cancer testing service against the standard-of-care cystoscopy.

The Birmingham, UK-based firm said that the trusts are recruiting 1,400 patients for studies to evaluate the performance of the company's urine-based Galeas Bladder test, and the company expects that results from that research will be reported in Q4 2024. All patients in the study will receive cystoscopies as well as provide a urine sample for testing using Galeas Bladder. The results will be compared to determine the sensitivity and specificity of the urine-based test.

Further studies that are planned for Q1 2025 will be used to evaluate the use of Galeas Bladder to monitor bladder cancer patients for disease progression or reemergence, as well as to determine the health economic and ecological outcomes of using the test.

Informed Genomics is a spinoff of liquid biopsy firm Nonacus, which launched the Galeas Bladder test in March 2023. The test uses next-generation sequencing to analyze 23 genes in the urine of patients with hematuria and identify somatic mutations that are associated with 96 percent of bladder cancers.

The firm had said late last year it had forged a deal to offer Galeas Bladder to customers of the UK's largest private insurer, Bupa, and the firm hoped to further expand its reach through the private market and healthcare providers within the NHS.

The company said Wednesday that the studies by the NHS will help to determine whether Galeas Bladder should become available through the NHS for routine care. It noted that the NHS reported about 110,000 patients are referred for cystoscopies each year, a figure that could be reduced by about 90 percent through the use of Galeas Bladder.