Clinical Utility of Cxbladder to Headline at AUA 2024

A ground-breaking study demonstrating the clinical utility of Cxbladder is to be the centrepiece of Pacific Edge’s activities at the 2024 American Urological Association (AUA) Annual Meeting to be held May 3 – 6 in San Antonio, Texas.

The AUA Annual Meeting represents a unique opportunity for Pacific Edge to highlight the findings of the new STRATA study and drive the adoption of Cxbladder tests. The conference, now in its 119th year, is the largest and most influential event in the US and global urological calendar, and is expected to attract over 10,000 urologists, urologic oncologists, researchers, educators, advanced practice providers, and other healthcare professionals from across North America and around the world.

STRATA, the first ever randomized controlled trial of a urine biomarker for hematuria evaluation, demonstrates Cxbladder Triage can help clinicians to safely and more effectively risk-stratify low risk hematuria patients when compared to AUA guidelines. It provides the strongest clinical utility evidence yet for inclusion of Cxbladder products in a future update to the hematuria guidelines.

The STRATA study will be presented on the podium by Dr Yair Lotan, Professor of Urology at UT Southwestern. The presentation is scheduled during a session covering advances in bladder cancer care on the morning of the first day of the conference (Friday May 3).

STRATA will also be published in the prestigious Journal of Urology on the same day and will be promoted as “practice changing research” by the AUA and the Journal of Urology in the lead up to, during, and after the event. A link to the paper is provided below (and will only become active at the commencement of the podium presentation at 10:40am Friday May 3 CDT). A selection of published comments by key reviewers of the paper will also be made available following the event.

Referencing the clinical utility of the test, authors of the paper led by Dr Lotan, said in an abstract to the study that Cxbladder Triage “can help reduce the burden of unnecessary cystoscopies… resulting in less patient morbidity and discomfort, improved access to care, and reduced environmental impact”.

The study showed clinicians in the test arm of the STRATA study, who could use information generated by a Cxbladder Triage test to help them determine the intensity of a patient workup, undertook 59% fewer cystoscopies than those clinicians in the control arm of the study who could not use the information from the Cxbladder test.

With the STRATA podium presentation providing a focal point for discussion throughout the event, Pacific Edge will be hosting a booth in the main hall alongside a range of other targeted activities through which the team will engage with customers and other attendees.

This year Pacific Edge will sponsor a tabletop session during the Urological Society for American Veterans (USAV) sub-meeting. This meeting will be attended by urologists working within Veterans Affairs (VA) facilities and is of particular importance as the company progresses its DRIVE and microDRIVE studies, both focused on VA patient cohorts.

Further detail on scheduled sessions at AUA 2024:

• 10:40am - 10:50 AM, Friday May 3 (CDT): Podium presentation - A Multicentre Prospective Randomized Trial Comparing Cxbladder Triage to Cystoscopy in Patients with Microhematuria.
• 10:00am - 2:30 PM Sunday May 5 (CDT): USAV Tabletop Session (Grant Hyatt, Texas Ballroom C).

Pacific Edge’s CEO, Dr. Peter Meintjes says: “The invitation to present the results of STRATA as practice changing research at AUA 2024, the world's most important meeting of urologists, reflects its first of a kind status and the potential for Cxbladder tests to redefine the standard of care. Going forward, patients presenting with microhematuria with a negative Cxbladder test, can be treated as AUA low risk, safely reducing the need for cystoscopy allowing urology teams to focus their time and clinical resources on those that need it the most, while reducing the burden of invasive testing on patients.

"STRATA provides the strongest case yet for AUA hematuria guidelines inclusion. Additionally, we will use the paper as the basis of a reconsideration request to Novitas¹ regarding ‘Genetic Testing for Oncology’ local coverage determination (DL 39365)."

View the STRATA study published in the Journal of Urology. Please note that this link will become active at the commencement of the AUA podium presentation: 10:40am Friday May 3 (CDT).

¹ Novitas, the Medicare Administrative Contractor with responsibility for Pacific Edge’s US laboratory, is currently reviewing Pacific Edge’s submissions on DL39365 and those of industry, the urological community and healthcare payers. Novitas must withdraw or finalize the draft determination by 26 July 2024.