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3N Diagnostics prepares for launch of breast cancer test

  • A new test developed by a Northern Ireland company which can identify an aggressive form of breast cancer earlier than previously possible is due to launch this autumn in Europe, with a view to being made available across the UK and Ireland at the start of next year.

    In preparation, 3N Diagnostics, which is based in Belfast, said it has signed an exclusive distribution agreement with Italian firm Bio-Optica Milano S.p.A. for its novel and patented AvisioTM FOXC1 immunohistochemistry test for basal-like breast cancer (BLBC). 

    BLBC is an aggressive type of cancer which is difficult to identify at the time of initial diagnosis. It can currently only be diagnosed two-to-five years afterwards, at which point patients are presented with a worse course of the disease, with effective therapy having been compromised by this point. 

    The distribution arrangement will focus on the distribution of the diagnostic firm’s novel and patented AvisioTM FOXC1 immunohistochemistry test for basal-like breast cancer (BLBC) in Italy.

    3N Diagnostics has identified and characterised Forkhead Box C1 (FOXC1) expression as a specific biomarker unique to BLBC. 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 AvisioTMFOXC1 test is designed to positively identify previously undetectable BLBC cells using standard IHC methods. 

    AvisioTM FOXC1 has obtained CE Marking, signifying compliance with European IVDD requirements. FOXC1’s role as a biomarker for BLBC has been validated in more than 5,000 breast cancer patients, with the AvisioTM FOXC1 test having been used in various clinical trials in over 1,400 patients. 

    Dr Roberto Fagnani, CEO of 3N Diagnostics, said: “We are delighted to have entered into a distribution agreement with Bio-Optica Milano. Its distribution channels for the AvisioTM FOXC1 test is ultimately helping to personalise cancer diagnostics for patients across Italy.”

    Cristioano Sbona, Sales Director of Bio-Optica Milano commented: “As the first Italian company to provide an easy-to-use test for this extremely aggressive cancer sub-set, we are excited to be involved in this major milestone for Italian breast cancer patient.” 

    Dr Partha S. Ray, 3N Diagnostics’ Chief Scientific Officer and inventor of the AvisioTMFOXC1 test said: “With the new, easy-to-use AvisioTM FOXC1 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.”

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