Diagnostic breast cancer test obtains CE Marking

A diagnostic test for an aggressive form of breast cancer, basal-like breast cancer (BLBC), has obtained CE Marking. The Avisio FOXC1 immunohistochemistry (IHC) test is available from 3N Diagnostics (3NDx).

The company identified and characterised Forkhead Box C1 (FOXC1) expression as a specific biomarker unique to the BLBC molecular subtype in breast tumour samples. At a microscopic level, BLBC cells may appear identical to less aggressive cancer cells. The Avisio test has been designed to positively identify BLBC cells with standard IHC methods.

“With the new, easy-to-use Avisio test, it is now possible to detect the lethal BLBC sub-type early in the disease process, even in resource challenged regions of the world,” said Dr Partha S. Ray, chief scientific officer and inventor of the Avisio test. “This is key to providing the most effective treatment possible, as early as possible, to any patient diagnosed with this aggressive cancer.”

“Obtaining CE Marking for Avisio FOXC1 culminates a major milestone which included the validation of the test in more than 5,000 patients and performing clinical trials in 1,429 patients,” explained Roberto Fagnani, PhD, CEO of 3N Diagnostics. “We have also identified several promising strategies for targeted therapy of BLBC and are excited at eth prospect of working with our colleagues in Pharma and Biotech to develop bespoke treatment plans for BLBC guided by the use of the Avisio FOXC1 test.”

Currently, a pilot launch of the test is taking place in 10 oncology centres across Europe. It is anticipated the commercial launch will happen in July throughout the EU and countries that recognise CE Marking.