The Avisio FOXC1 immunohistochemistry (IHC) test for basal-like breast cancer (BLBC) from 3N Diagnostics (3NDx), Belfast, UK, has obtained the CE mark. A pilot launch is currently taking place in 10 oncology centers in Europe.
On microscopic examination of breast tissue, BLBC cells may appear identical to less aggressive cancer cells. In breast tumor samples, 3N Diagnostics has identified and characterized expression of the forkhead box C1 (FOXC1) gene as a specific biomarker unique to the BLBC molecular subtype.
According to the company, evaluating FOXC1 expression enables accurate detection of BLBC in both estrogen-receptor-positive (ER+) and estrogen-receptor-negative (ER–) breast tumors. The Avisio test is designed to identify previously undetectable BLBC cells positively using standard IHC methods.
“With the new, easy-to-use Avisio test, it is now possible to detect the lethal BLBC subtype early in the disease process, even in resource-challenged regions of the world,” says Partha S. Ray, MD, chief scientific officer at 3N Diagnostics 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.”
Pathologists will have access to the Avisio FOXC1 test without the need to purchase additional processing or specialized staining equipment. Use of the test seeks to 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.
“Obtaining CE marking for Avisio FOXC1 culminates a major milestone [that] included the validation of the test in more than 5,000 patients and performing clinical trials in 1,429 patients,” says Roberto Fagnani, PhD, CEO of 3N Diagnostics. “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.”
For more information, visit 3N Diagnostics.