Breakthrough designation for Imagion test

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Imagion Biosystems (ASX:IBX), an Australian company dedicated to improving healthcare through the earlier detection of cancer, has received notification from the FDA's Center for Devices and Radiological Health (CDRH) that its MagSense System and Test for staging HER2 breast cancer has qualified for and been granted designation as a Breakthrough Device.

“The FDA’s designation of our MagSense technology and HER2 test as a Breakthrough Device is a significant step in our clinical development program,” said executive chairman Bob Proulx.

“Qualifying as a Breakthrough Device will allow us to expedite our dialogue with the agency and validates that our MagSense technology is not just another medical device but, indeed, represents a transformative opportunity for healthcare and could improve the standard of care for staging HER2 breast cancer."

The company’s MagSense test for the staging of HER2 breast cancer aims to eliminate the unnecessary surgeries and concomitant morbidity resulting from the current standard of care, biopsy procedure. The company said it is currently discussing with the FDA and clinical study sites its plans to undertake a first-in-human study of the MagSense HER2 Test.