That included Medicare Administrative Contractor (MAC) Novitas making a favourable policy decision on the draft genetic testing for oncology Local Coverage Determination, the American Urological Association’s ongoing review of microhematuria standards of care leading to language favourable to Cxbladder in its new guidelines, and the Centres for Medicare and Medicaid Services (CMS) finalising pricing recommendations for the company’s next generation test, Cxbladder Triage Plus, that recognised its clinical and economic value, an announcement to the NZX said.
Operating revenue increased 1.4% on 2H24 to $11million, down 16.3% on 1H24 reflecting Medicare uncertainty and the reduced reach of a smaller sales team. Total revenue was down 4.4% on 2H24 to $12.2million.
Total laboratory throughput of Cxbladder tests was down 1.1% on 2H24 to 14,233, down 22% on 1H24 while commercial tests increased 3.2% on 2H24 to 12,323 tests. The company’s after-tax net loss of $14.5million was steady on the $14.3m net loss in 2H24, down 4.9% on 1H24 net loss of $15.3m .
Yesterday, chief executive Dr Peter Meintjes cited the “tremendous” work the team had done in the background on strategic initiatives, including Strata, which was published in the Journal of Urology in May, and the first randomised control trial of a urine biomaker.
Analytical validation of all Pacific Edge’s legacy products had been published, a direct rebuttal to some of the criticism in the Novitas evidentiary review, he said.
The two-year wait continued for Novitas to finalise or withdraw its local coverage determination. It was August 2022 that the company learned its Cxbladder tests could be dropped by Novitas, those tests representing a significant portion of testing revenue.
As every day passed, Dr Meintjes believed it became more likely to be a favourable outcome for Pacific Edge although that was not guaranteed. It was difficult to make the right decisions with the uncertainty hanging over the company and he believed it had done well “under the circumstances”.
He said he was as optimistic as he had ever been in the long-term outlook.
Pacific Edge had created a value-generated pipeline that could branch out into other areas, such as prostate or liver, in the future.
With $35.9m in reserves as at the end of September, chairman Chris Gallaher said the company had sufficient capital to re-establish reliable reimbursement for its tests in the event of a negative determination from Novitas.
sally.rae@odt.co.nz
