NEW STUDY SHOWS UROAMP CAN DETECT BLADDER CANCER NOT FOUND BY CYSTOSCOPY OR URINE CYTOLOGY

Noninvasive Genomic Urine Test Demonstrates High Accuracy in Predicting Recurrence Before Clinical Signs or Symptoms Emerge

SOUTH SAN FRANCISCO, Calif., Aug. 22, 2023 /PRNewswire/ -- UroAmp, the noninvasive genomic urine test developed by Convergent Genomics, can detect bladder cancer or predict its recurrence before clinical signs or symptoms appear, according to a newly published study in the journal Clinical Cancer Research.

In a multi-center case-control study, researchers from leading academic centers and urology practices throughout the United States* compared UroAmp's diagnostic and prognostic performance for bladder cancer to standard-of-care procedures, like cystoscopy, cytology and pathology. A total of 581 patients were analyzed, including those undergoing evaluation of hematuria (blood in the urine) as well as those being monitored for recurrence after surgery.

UroAmp uses next-generation DNA sequencing to deeply interrogate 60 of the most high-impact urothelial cancer genes for mutations while broadly measuring changes across the whole genome. A comprehensive genomic profile is then generated providing prognostic information about a patient's cancer and predicted responses to genome-targeted drug therapies.

Most striking among the findings was UroAmp's ability to detect minimal residual disease in surveillance patients after cystoscopy and urine cytology, with many predicted recurrences identified more than a year ahead of a clinical diagnosis. Patients identified as high-risk were six times more likely to have their cancer return than low-risk patients – critical information given bladder cancer has an overall recurrence rate of 60% to 70% following treatment. Further, in the initial diagnosis setting, bladder tumors were detected with a sensitivity of 95% and specificity of 90%. 

"These findings demonstrate the power of genomics in detecting minimal residual disease from urine and accurately stratifying a bladder cancer patient's risk to better inform decisions about their treatment and surveillance," said Keyan Salari, MD, PhD,** lead study author and Assistant Professor of Urology at Harvard Medical School and Massachusetts General Hospital.

The study builds upon recent discoveries from large public research efforts, further defining the most important areas of the genome commonly mutated in bladder cancer. Gene associations with tumor grade and bladder invasion were identified. A UroAmp molecular grade prediction algorithm identified high-grade cancers with a positive predictive value of 88% and a specificity of 95%. Many of the mutations found in this study are also being investigated as targets for new drugs or for predicting response to existing FDA-approved therapies.

"The combination of prognostic insights, therapeutic targets, and the ability to non-invasively monitor genomic response over time with UroAmp presents a new paradigm to enhance clinical trials and to ultimately better personalize care and improve outcomes," said study co-author Trevor Levin, Ph.D., Founder and CEO, Convergent Genomics.

Convergent Genomics has developed leading expertise in urinary genomics, including the development of a patented sample collection and preservation system, robotic nucleic acid extraction methods, and high-accuracy molecular analysis. Several studies are currently underway to determine the effectiveness of UroAmp in predicting response to the latest cancer drugs and in uncovering the genomic causes of exceptional treatment successes.

Earlier this year, a study presented at the 2023 American Urological Association (AUA) Annual Meeting showed UroAmp could help doctors accurately predict bladder cancer as many as 12 years before clinical signs and symptoms emerge.

The American Cancer Society estimates that more than 82,000 people will be newly diagnosed with urothelial carcinoma (bladder cancer), and over 16,700 will die in the US this year. More than 700,000 people currently live with the disease in the US.

About Convergent Genomics
Convergent Genomics was founded in 2015 by a team of cancer biologists, urologic oncologists, and data scientists, in partnership with Oregon Health & Science University (OHSU) and Illumina Accelerator. The company has received multiple peer-review grants from the National Cancer Institute and is engaged in research with over 30 sites worldwide, including leading academic centers. Convergent Genomics operates clinical laboratories in South San Francisco that are certified by the California Department of Public Health and nationally by CLIA-CMS. For more information visit www.convergentgenomics.com.

*Massachusetts General Hospital, Broad Institute of MIT and Harvard, The Ohio State University Comprehensive Cancer Center & Pelotonia Institute for Immuno-Oncology, University of Texas Southwestern Medical Center Dallas and Oregon Health & Science University, and private practices, Golden Gate Urology in California and Willamette Urology in Oregon.
Research reported in this publication was supported by the National Cancer Institute of the National Institute of Health under Award Number R44CA200174. This award supported sample procurement, materials and supplies, computer services, and personnel. All other costs were funded by Convergent Genomics.
**Received research support from Convergent Genomics

SOURCE Convergent Genomics