TEST:

Cxbladder

P=N/A, N=1000, Recruiting, Pacific Edge Limited | Trial completion date: Dec 2024 --> Mar 2025 | Trial primary completion date: Dec 2024 --> Mar 2025

"New data demonstrating the clinical and economic value of Pacific Edge’s Cxbladder cancer diagnostic tests will be in the spotlight at the 100th annual meeting for the Western Section of the American Urological Association (WSAUA) in Kauai, Hawaii."

Cxbladder had high analytical accuracy (≤10.63% inaccuracy across all biomarkers) and good reproducibility (>85% concordance between laboratories). Cxbladder accurately and reproducibly detects UC biomarker expression and can aid clinicians in risk stratification of hematuria patients or those undergoing surveillance for recurrent UC.

"Pacific Edge CEO, Dr Peter Meintjes will present the clinical utility evidence from the STRATA study to an APAC audience for the first time. STRATA is the first randomly controlled trial of a urine-based biomarker for hematuria evaluation ever completed. It demonstrated that presenting clinicians with a Cxbladder Triage result led to a 59% reduction in cystoscopies, the primary endpoint of the study."

"Pacific Edge welcomes an editorial in the American Urological Association’s Journal of Urology supporting the use of Cxbladder to reduce unnecessary cystoscopies on patients at risk of bladder cancer."

"Pacific Edge notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge’s US lab, has confirmed that it has been granted an extension to finalize or withdraw the Local Coverage Determination (LCD) ‘Genetic Testing for Oncology’ (DL 39365)...Pacific Edge expected the LCD, which could impact Medicare coverage of its Cxbladder tests, to be withdrawn or finalized last Thursday evening (NZDT), i.e. within 365 days of the initial posting."

"Pacific Edge notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge’s US lab, remains in discussion with the Centers for Medicare & Medicaid Services (CMS) regarding the Local Coverage Determination (LCD) ‘Genetic Testing for Oncology’...The continued deliberation on the LCD means that Pacific Edge’s tests Cxbladder Triage, Detect and Monitor continue to receive reimbursement from Medicare and Medicare Advantage payers in line with historical reimbursement rates and subject to medical necessity guidelines."

P=N/A; Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: May 2024 --> Dec 2024

Our analysis finds that while these tests may provide some clinical utility, none of the assays have thus far demonstrated objective evidence to supplant the gold diagnostic standard.

In this prospective randomized controlled trial, use of CxbT in patients with LR hematuria resulted in 59% reduction of cystoscopy use. This clinical utility of Cxbladder Triage can reduce the burden of unnecessary cystoscopies.

"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."

P=N/A, N=1000, Not yet recruiting, Pacific Edge Limited

P=N/A; N=300 --> 0 | Not yet recruiting --> Withdrawn

In this prospective multicenter randomized controlled trial, use of Cxbladder Triage to inform the decision for cystoscopy in patients with lower risk asymptomatic microscopic hematuria resulted in a 52% reduction in cystoscopy. This demonstrated clinical utility of Cxbladder Triage can help reduce the burden of unnecessary cystoscopies in this population resulting in less patient morbidity and discomfort, improved access to care, and reduced environmental impact.

P1; Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Jun 2026 --> Nov 2026

P=N/A; Recruiting --> Active, not recruiting

P=N/A; Not yet recruiting --> Recruiting

P=N/A; N=107; Recruiting; Sponsor:Mayo Clinic

P=N/A; Not yet recruiting --> Recruiting

"Pacific Edge announces the launch of the integration of Cxbladder tests within the Electronic Medical Records (EMR) system of Kaiser Permanente."

P=N/A; N=107; Not yet recruiting; Sponsor:Mayo Clinic

This model-based study demonstrates the potential economic value of using a Cxbladder-driven protocol for microhematuria evaluations.

P1, N=80, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Jun 2026

"Pacific Edge notes the U.S. Food and Drug Administration (FDA) has released for public comment proposed rule changes that seek to have Laboratory Developed Tests (LDTs) such as Cxbladder regulated as medical devices under the US Federal Food, Drug, and Cosmetic Act...The proposed changes, if finalized, would require Pacific Edge and other LDT providers to present evidence to the FDA that their tests are safe and effective for their intended use in addition to the current regulatory pathway of being accredited through CLIA (Clinical Laboratory Improvement Amendments)."

P=N/A; Not yet recruiting --> Recruiting

P=N/A; Recruiting --> Active, not recruiting

"Pacific Edge...releases details of written submissions on the draft local coverage determination (LCD) that proposes non-coverage of Cxbladder tests by Medicare, the US national health insurance provider...The written submissions argue Cxbladder Triage, Detect and Monitor tests should retain Medicare coverage based on the clinical value they offer to patients, clinicians, and healthcare payers."

P=N/A; N=800; Not yet recruiting; Sponsor:Ferring Pharmaceuticals

"Pacific Edge welcomes the strong industry and clinician support it has received during the open public meetings to take feedback on draft local coverage determinations (LCDs) that propose non-coverage of Cxbladder tests by Medicare, the US national health insurance provider."

"Pacific Edge notes the release overnight of a new proposed Local Coverage Determination (LCD) governing the reimbursement of its Cxbladder tests by Medicare, the US National Health Insurance provider...The proposed LCD (DL39365), released by the Medicare Administrative Contractor (MAC) Novitas2, notes the Cxbladder tests are ‘not considered medically reasonable and necessary’, the threshold required for coverage under the US Social Security Act."

"Pacific Edge...welcomes a decision from Novitas and First Coast to delay the implementation of the Local Coverage Determination (LCD, L35396) released in early June that would have seen Medicare coverage of Cxbladder cease in the US on 17 July 2023."

"Pacific Edge...announces an update to its billing policies in the US for Cxbladder tests...From 17 July 2023, Pacific Edge will provide for enhanced patient responsibility where a patient’s insurer declines to pay for a Cxbladder test. Pacific Edge will also update its Patient Assistance Program to assist lower income patients with making their bill more affordable."

"Pacific Edge...announces Medicare coverage of Cxbladder tests in the US market is expected to cease from 17 July 2023...This development follows the finalization of a Local Coverage Determination (LCD) (L39365) by Novitas, the Medicare Administrative Contractor (MAC) with jurisdiction for Pacific Edge’s laboratory in Hershey Pennsylvania."

P=N/A; N=1000; Not yet recruiting; Sponsor:Pacific Edge Limited

P=N/A; Not yet recruiting --> Recruiting

"Pacific Edge...announces it has completed the software development and integration testing on its project to integrate Cxbladder into the Electronic Medical Records (EMR) system of Kaiser Permanente."

P=NA | N=92| "Cancer diagnostics company Pacific Edge...today welcomes the release of new research supporting the clinical utility of the company’s genomic biomarker test Cxbladder Monitor in the surveillance for bladder cancer recurrence....Of the sample, 66 patients tested negative for Cxbladder Monitor. Of those, 52 patients underwent a follow up cystoscopy, and all were tumor free – a result that supports the growing portfolio of evidence that Cxbladder Monitor can safely reduce surveillance cystoscopies without compromising cancer detection. Meanwhile, a patient satisfaction survey of those who took the Cxbladder Monitor test at UCSF revealed strong patient acceptance for the test and the PIHSS."

"Pacific Edge...announces its key activities and highlights at the 87th Annual AUA Southeastern Section (SESAUA) meeting to be held March 15-18 in Amelia Island, Florida...Alongside the Symposium, Pacific Edge will lead a Principle Investigator Meeting for the DRIVE study – a study focused on Cxbladder validation in a veterans cohort across multiple VA sites for which it plans to conclude enrolment in 2023."

CxM safely reduces frequency of surveillance cystoscopy in real-world settings and appears acceptable to patients as an at-home test.

"Urinary biomarkers might have a complementary place in bladder cancer diagnosis and NMIBC surveillance. However, their clinical benefit remains to be confirmed."

"This study in ethnically diverse patients with hematuria showed the analytical validity of the enhanced Cxbladder tests."

"Pacific Edge...announces the acceptance for publication of new clinical evidence that shows significant improvements in the performance of its genomic diagnostic Cxbladder tests. These performance improvements were achieved by the addition of DNA biomarkers to Cxbladder Triage (CxbT) and Cxbladder Detect (CxbD), Pacific Edge’s products for hematuria evaluation."