Nymox takes AlzheimAlert urine test kit to EU:
This article was originally published in Clinica
Nymox Pharmaceutical has CE-marked for sale in Europe its urine test kit for helping to diagnose Alzheimer's disease. AlzheimAlert measures the level of the brain protein NTP (neural thread protein), which the Maywood, New Jersey firm says is found in higher amounts in the urine of patients suffering from the disease. A premarket approval (PMA) application to market the test in the US was recently turned down by the FDA, after the agency said that issues concerning the company's clinical study methodology meant that it could not approve the PMA in its current form. The FDA's decision did not restrict Nymox' ability to market and sell AlzheimAlert under CLIA regulations; the test is marketed as a clinical reference laboratory service provided by its government-inspected clinical reference laboratory in New Jersey.
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