Pacific Edge’s eyes on decision

Cancer diagnostics company Pacific Edge says it has a range of strategies, including a potential legal challenge, should a Medicare non-coverage determination be delivered.

Releasing the company’s full-year financial results yesterday, chief executive Dr Peter Meintjes said the finalisation of the coverage determination remained the biggest determinant of its prospects for the immediate future. A decision is due by July 26.

A non-coverage determination was likely to affect United States volumes but the company was well prepared with plans to regain coverage and, should it be affirmed, rebuild the momentum in the clinical adoption of Cxbladder in the US and around the world, Dr Meintjes said.

In the event of a non-coverage determination, strategies included a possible legal challenge, Medicare patients assuming responsibility for the payment of Cxbladder tests and the continued advancement of Pacific Edge’s clinical evidence programme, which would give it "multiple opportunities" to seek a coverage reconsideration.

There was a range of outcomes so it was a case of "wait and see".

Regardless of the determination, the company’s value proposition was unchanged and there was a "fantastic opportunity" for the company, he said.

Operating revenue increased 22% to $23.9 million from $19.6m in FY 23, slowed by the underlying reduction in commercial test volume in 2H 24. Total laboratory throughput (TLT) growth slowed in the second half of the year. That followed the reduction of the sales team in Q2 24 to drive efficiency and preserve capital.

TLT increased 3% to 32,633 tests from 31,565 in FY 23, while commercial test volumes increased 2% to 27,347 tests from 26,691 in FY 23.

The net loss for the year was $29.5m, compared with $27m the previous year, as the company continued to invest in long-term growth initiatives and incurred one-off restructuring costs, the statement released to the NZX said.

Chairman Chris Gallaher, who is stepping down at the end of the year, said the board was pleased with the progress Dr Meintjes and his team had made as the company worked towards gaining certainty on Medicare coverage.

"They have acted swiftly regarding the need to preserve capital through uncertainty and retained their focus on the strategic imperatives in clinical evidence generation that will underpin our future success and prepare the company for all outcomes." he said.

Pacific Edge’s STRATA study was published in the Journal of Urology this month, nine months ahead of schedule. The study headlined at the American Urological Association (AUA) annual conference, the world’s largest urological meeting, and provided the strongest evidence yet for the inclusion of Cxbladder in guidelines for hematuria evaluation.

Specifically, it demonstrated Cxbladder could safely and more effectively risk-stratify low-risk hematuria patients when compared with AUA guidelines, thereby reducing the number of unnecessary invasive cystoscopies, the report said.