Cxbladder Volumes Weaken After Coverage Loss

Pacific Edge today reports Cxbladder tests processed through its laboratories in the three months to the end of September 2025 (Q2 26) have weakened amid the disruption caused by transitioning US customers from Detect to Triage and the extra administrative processes faced by healthcare payers and clinicians since the loss of Medicare coverage in April 2025.

The volume data is carried in the Q2 26 investor update, which also covers:

• Notification that the DRIVE Study, which demonstrates the clinical validity of Cxbladder Triage Plus in a veterans’ population, has been accepted for publication in the Journal of Urologic Oncology¹. This publication provides the clinical validation evidence necessary for us to formally request our Medicare Administrative Contractor Novitas to consider coverage for Triage Plus.

• Further detail on Novitas’ decision to convene a panel of experts to discuss evidence for the use of urine biomarkers in patients with microhematuria. The panel is scheduled to be convened on 19 February 2026 at 6pm (ET). Its formation demonstrates that Novitas recognizes the importance of the AUA’s update to the 2025 Microhematuria Guideline and understands the strength of the evidence supporting Cxbladder.

• Our change to the name of our next generation test Monitor Plus to Surveillance Plus to better reflect its intended use as a tool for the surveillance for bladder cancer recurrence.

Total laboratory throughput (TLT) in Q2 26 fell 9.0% to 6,286 tests from the 6,905 tests in Q1 26. US TLT was down 13.1% to 4,971 from 5,722 in Q1 26. APAC volumes were up 11.2% to 1,315 from 1,183 tests in Q1 26, largely reflecting an increase in clinical study volumes.

In the US Pacific Edge accelerated the decision to discontinue Detect following the inclusion of Triage in the new American Urological Association (AUA) Microhematuria Guideline in February 2025 and the Medicare non-coverage determination. We have successfully concluded that migration, with Triage and Triage Plus now accounting for 82% of tests processed at our US laboratory, up from 22% in Q4 25, the last quarter before the non-coverage determination.

Reflecting a reduction in our sales force we have seen an improvement in our sales force efficiency metric (tests per sales FTE) to 403 from 381 tests per sales FTE in Q1 26. The sales force reduction, and the loss of Medicare coverage has also impacted the number of ordering clinicians (803 ordering clinicians in Q2 26, down from the 907 in Q1 26). Tests per unique ordering clinician were steady at 6.2 in Q2 26 compared to 6.3 in Q1 26.

The fall in the number of ordering clinicians reflects the challenges associated with selling noncovered products, including the additional administrative processes imposed on clinicians and general market confusion caused by migrating customers from a well-known test to an unfamiliar one and the subtle differences in patient population for different Cxbladder tests. The additional burdens include the requirement to provide patients with an advanced beneficiary notice (ABN) informing them they may be held financially responsible for the test if Medicare denies payment. ABNs insulate Pacific Edge from test non-payment.

View the Investor Update: here.

¹ Savage et al., Accepted October 6, 2025. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at Risk for Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study.