Key Highlights

  • Proposed Medicare prices for 2027 would rise to US$1,026 for Cxbladder Monitor and US$1,058 for Cxbladder Triage, from US$760.
  • US commercial volumes fell 13.0% to 2,867 tests, while Asia Pacific commercial volumes rose 3.7% to 1,201 tests.
  • Blue Cross plans in North and South Carolina, covering nearly 8 million lives, will cover Cxbladder in-network from 1 November 2026.
  • Triage Plus represented 5.6% of US tests in Q2 27, up from 0.8% in Q1 27, and 10.8% in September 2026.

Pacific Edge Limited (ASX:PEB), which is also listed on the NZX, released its Q2 27 Investor Update on 19 October 2026. The Dunedin-based cancer diagnostics company reported proposed Medicare pricing, new payer arrangements, test volumes and clinical study publications for its Cxbladder tests.

Proposed Medicare pricing

The Centers for Medicare & Medicaid Services released preliminary 2027 Clinical Laboratory Fee Schedule rates under the Protecting Access to Medicare Act. They propose US$1,026 for Cxbladder Monitor, a rise of about 35%, and US$1,058 for Cxbladder Triage, a rise of about 39%, from the current US$760. The rates are subject to CMS finalisation and would take effect on 1 January 2027. The company noted that the rates do not determine whether a test is covered, because coverage and payment are separate decisions, and that it still expects the Novitas local coverage determination to be finalised by the end of calendar 2026.

Payer and Veterans Administration developments

Blue Cross Blue Shield plans in North and South Carolina adopted a positive medical policy for Cxbladder Triage and agreed contracting terms to reimburse the test in-network from 1 November 2026, covering nearly 8 million lives. Separately, Triage Plus received a funding allocation within the Veterans Administration, a five-year Blanket Purchase Agreement of about US$1.3 million with the Marion, Illinois facility for Triage Plus and Monitor.

Test volumes

US commercial volumes declined 13.0% to 2,867 tests from 3,296 in Q1 27, as the company kept commercial spending lower and repositioned towards intermediate risk microhematuria patients. Asia Pacific commercial volumes rose 3.7% to 1,201 tests from 1,158. Total laboratory throughput was 5,258, up 2.7% from 5,120, as more clinical study samples were processed.

Triage Plus represented 5.6% of US tests in Q2 27 and 10.8% in September 2026, and 8.1% of Asia Pacific tests, up from 7.6%. Commercial tests per sales FTE were 573 against 659, and unique ordering clinicians were 704 against 814, while tests per clinician edged up to 4.1 from 4.0.

Medicare coverage process and commercial approach

The draft Medicare coverage policy distinguishes microhematuria patients from cancer patients in the non-coverage determination, and the company is working with Novitas on case-by-case payments for eligible tests delivered to Medicare patients before the policy is finalised. Pacific Edge said it has deliberately reduced commercial spending while awaiting the final policy, concentrating resources on productive accounts and integrated delivery networks, and that Kaiser Permanente remains its largest single contributor to US volume. It also appointed Willy Iglesias as Chief Digital Officer during the quarter.

Clinical evidence

A Canterbury study published in the ANZ Journal of Surgery audited 4,512 hematuria referrals between March 2013 and December 2021. Median waiting time from referral to a specialist appointment fell 14.8 days, from 57.8 to 43.0 days, and median time to first operative treatment fell 15.0 days, from 78.0 to 63.0 days. Monthly specialist referrals fell from 45.7 to 38.8. The AUSSIE study, accepted by BJU International, enrolled 691 evaluable patients across four Australian clinics and reported a 74% test-negative rate. Enrolment of about 2,000 patients was achieved in the Triage Plus concordance study with KP SoCal.

In the AUSSIE study, the test-negative rate was 81% in microhematuria patients, with a negative predictive value of 100%, and 70% in gross hematuria patients, with a negative predictive value of 98%.