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SUMMARY

After first part of the project phase 2, in which approximations were made with The Spanish Agency for Medication and Healthcare Products (AEMPS) and European Agency Medicine (EMA). The zebraONCOfish platform was determined to be a companion diagnostics test.

One of the most important barriers what Companion Diagnotics (CDx) can find to enter the market are the regulatory pathways to be followed for approval before commercialization. CDx are a type of diagnostics tests, designed to help doctors better customize treatments for individual patients, based on their unique biology. Therefore, one of the first points is to study very thoroughly the regulatory frameworks of the two target areas where this tool will be introduced, Europe and North America (USA).