3N Diagnostics has entered into an exclusive distribution agreement with Bio-Optica Milan.
The agreement is centred on the distribution of 3N Diagnostics’ novel and patented Avisio FOXC1 immunohistochemistry test for basal-like breast cancer (BLBC) in Italy.
BLBC is a type of cancer which is difficult to identify at the time of initial diagnosis. It is only diagnosed two – five years afterwards, when patients return with an unexpectedly worse course of the disease, at which point, effective therapy has been compromised.
3N Diagnostics has identified and characterised Forkhead Box C1 (FOXC1) expression as a specific biomarker unique to BLBC. Evaluating FOXC1 expression enables accurate detection of hitherto occult BLBC in both ER+ as well as ER- breast tumours, meaning testing is recommended for all breast tumour samples.
Avisio FOXC1 has obtained CE Marking, signifying compliance with the European In-Vitro Diagnostics Devices Directive (98/79/EC). The role of FOXC1 as a specific biomarker for BLBC has been validated in more than 5,000 breast cancer patients, and the AvisioTM FOXC1 test in various clinical trials with 1,429 patients.
Roberto Fagnani, PhD, CEO of 3N Diagnostics, said: “We are delighted to have entered into a distribution agreement with Bio-Optica Milano. This provides us with the distribution channels in the Italian market, making our new AvisioTM FOXC1 test for BLBC available to breast cancer patients in Italy.”
Partha S. Ray, MD, Chief Scientific Officer at 3N Diagnostics and inventor of the AvisioTM FOXC1 test, said: “With the new, easy-to-use AvisioTM FOXC1 test, it is now possible to detect the lethal BLBC subtype 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.”
Cristioano Sbona, Sales Director of Bio-Optica Milano, said: “We are happy to be the first Italian company that proposes an easy-to-use test able to identify a very aggressive sub-population of breast cancer.”
Source: Company Press Release