Imagion Biosystems (ASX: IBX) has received notification from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) that the MagSense System and Test for staging HER2 breast cancer had qualified for and been granted designation as a “breakthrough device”.
Imagion’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 for biopsy procedures.
As it stands, Imagion has confirmed that it is currently discussing with the FDA and clinical study sites to undertake a first-in-human study of the MagSense HER2 Test.
By qualifying as a breakthrough device, Imagion will participate in a purpose-built program that expedites and improves communications between device manufacturers and the regulatory agency during development.
The program includes a review process and provides “priority review” which could potentially lead to quicker marketability if products prove to be effective.
According to the FDA, to qualify for breakthrough device status, products must be considered to “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” and meet several criteria.
These including an ability to represent breakthrough technologies, address an application for which no approved or cleared alternatives exist, offer significant advantages over existing approved or cleared alternatives, and finally, be considered that the availability of the device is in the best interest of patients.
“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 Bob Proulx, executive chairman of Imagion.
“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,” Mr Proulx added.
This morning’s regulatory boost helped Imagion’s shares to more than double in value, going up 200% to $0.060.