FDA fast-tracks Australian breast cancer technology

Perth, Australia, May 3, 2021 – FDA fast-tracks Australian breast cancer technology

An Australian imaging device about the size of an electric toothbrush that could save breast cancer patients from going under the knife multiple times has been fast-tracked by the US Food and Drug Administration.

West Australian medical technology company OncoRes is ­behind the ­device that uses new technology to make real-time ­tumour assessments and help surgeons more accurately identify and remove cancerous tissue.

The FDA classified the new technology with “breakthrough device designation”, capable of providing more effective treatment of life-threatening or irreversibly debilitating diseases or conditions.

About 20,000 Australians were diagnosed with breast cancer last year, with the disease ­accounting for 14 per cent of new cancer diagnosis and 6.3 per cent of cancer-related deaths, according to Cancer Australia.

With a 96 per cent accuracy rating, this new technology is set to revolutionise breast-conserving surgery, said OncoRes chief medical officer and Fiona Stanley Hospital surgeon Christobel Saunders.

“The problem with breast cancer surgery is that it’s particularly difficult to know whether you’ve removed all the tumour or not,” Professor Saunders said.

“You’re basically operating blind; you’re removing what you can feel; you can never tell whether all of the tumour is ­removed at a microscopic level — what that means is that for a lot of women there will be ­another surgery.”

Professor Saunders, also an oncology professor at the University of Western Australia, said one in five patients underwent repeat surgeries, which increased their risk of further complications such as infection.

“About 50 per cent of the time the women say just do a mastectomy,” Professor Saunders said.

When Perth resident Ash Greenhough, 38, was diagnosed with grade-three breast cancer last year, her life was turned upside down.

She decided to proceed with a lumpectomy, had three surgeries followed by 12 weeks of chemotherapy and six of radiotherapy.

A week after her first surgery, Mrs Greenhough attended a screening and was told her battle was not yet over. “They’d accidentally cut out a second tumour they didn’t know was there. I was told it was a completely different kind of cancer,” she said.

Mrs Greenhough underwent two more surgeries.

“I didn’t actually need (the third surgery) at all but I’m so glad I got it,” she said, noting that technology capable of removing cancerous tissue in a single surgery would have make the battle cancer much easier.

“Still, it was another section of tissue, another operation and another scar. It’s such a shame,” she said. “I have no regrets but I hope other women will never have to go through that.”

OncoRes managing director and chief executive Katharine Giles said Australian medical technology companies had long focused on approval in the US market.

“It’s incredible global validation of our potential to make a difference in cancer and patient outcomes,” she said. “While we focused on breast in the first ­instance — all other solid cancers are on the table such as lung, prostate, brain and any other solid tumour.”

The Australian
Joseph Lam
3 May, 2021