Limitoo News

Pacific Edge given stay on US decision not to use its tests

The approvals gives Pacific Edge access to about 20 million Americans.
Novatis initially said the cancer test was "not considered medically reasonable and necessary", but has now opened the door to further submissions about its continued use. Photo: Supplied / Pacific Edge

Bladder cancer diagnostics company Pacific Edge has been handed a lifeline, after a US Medicare Provider said it would delay implementing a decision to no longer cover the company's flagship Cxbladder test.

The original decision by Novitas would have seen Medicare coverage of Cxbladder end in the US in less than two weeks, in what would have been a major revenue blow for Dunedin-based Pacific Edge.

Pacific Edge said the medicare provider would go through another determination process with an open meeting and with public comment.

It said there was no timeframe for the process.

Pacific Edge chief executive Peter Meintjes told the share market the company was pleased with the outcome.

"We are confirmed in our position that a more robust procedure that includes open meeting and public comment was needed and thank Novitas for the opportunity to discuss the substance of their evidentiary review of Cxbladder products with them," Meintjes said.

"We support efforts to ensure the Medicare program only pays for genetic testing services that are analytically valid, clinically valid, and clinically useful."

source: https://www.rnz.co.nz/news/business/493280/pacific-edge-given-stay-on-us-decision-not-to-use-its-tests