Pacific Edge down 13% on FDA plans

Cxbladder is a urine-based test for the detection and rule-out of bladder cancer in certain patients. (Image: Pacific Edge)

Rebecca Howard

Mon, 02 Oct 2023

Pacific Edge shares were down 13% in early trading after news the US Food and Drug Administration intends to regulate lab-developed tests, including CxBladder. The FDA has proposed rule changes that would see lab-developed tests regulated as a medical device under the US Federal Food, Drug, and Cosmetic Act, Pacific Edge said.The change would require the New Zealand cancer diagnostics company to present evidence to the FDA that its tests are safe and effective for their intended use, in addition to the current regulatory pathway.The...

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