3N Diagnostics (3NDx) has announced that its revolutionary Avisio FOXC1 immunohistochemistry (IHC) test for basal-like breast cancer (BLBC) has obtained CE Marking, signifying compliance with the European In-Vitro Diagnostic Devices Directive (98/79/EC). A pilot launch is currently taking place in 10 oncology centres in Europe. This will pave the way for its expected July 2017 commercial launch throughout the EU and countries recognising the CE Marking.
3NDx has identified and characterised Forkhead Box C1 (FOXC1) expression as a specific biomarker unique to the BLBC molecular subtype in breast tumour samples. On microscopic examination of breast tissue, BLBC cells may appear identical to less aggressive cancer cells. Evaluating FOXC1 expression enables accurate detection of BLBC in both ER+ as well as ER- breast tumours; meaning testing is recommended for all breast tumour samples. The Avisio test is designed to positively identify previously undetectable BLBC cells using standard IHC methods.
Pathologists will have access to the Avisio FOXC1 test without the need to purchase additional processing or specialised staining equipment. Use of the Avisio FOXC1 IHC test will enable early identification of BLBC upon initial patient presentation, allowing multidisciplinary cancer treatment teams to formulate the most appropriate plan for each individual patient. Early detection and early initiation of best available therapy can improve the prognosis and survival of those diagnosed with this cancer.
Partha S. Ray, MD, Chief Scientific Officer and inventor of the Avisio test commented: “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. This is key to providing the most effective treatment possible, as early as possible, to any patient diagnosed with this aggressive cancer.”
Roberto Fagnani, PhD, CEO of 3N Diagnostics said, “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. We have also identified several promising strategies for targeted therapy of BLBC and are excited at the prospect of working with our colleagues in Pharma and Biotech to develop bespoke treatment plans for BLBC guided by use of the AVISIO FOXC1 test.”