Nymox PMA Slated for FDA Advisory Panel Meeting

Nymox Pharmaceutical has been informed that its premarket approval (PMA) application to the FDA concerning a kit version of the company's AlzheimAlert urine test will be going forward to a presentation before a panel of the Medical Devices Advisory Committee.

In the PMA, the company is seeking FDA approval to sell kit versions of its AlzheimAlert test to qualified laboratories and hospitals in the U.S. AlzheimAlert is the company's proprietary urine test intended to aid physicians in the diagnosis of Alzheimer's disease. The test measures levels of a brain protein called neural thread protein, known to be elevated in the brain tissue, cerebrospinal fluid and urine of patients with Alzheimer's disease. The date for the panel meeting has yet to be confirmed.

AlzheimAlert is already certified as a laboratory testing service in the U.S. through the company's CLIA-certified clinical reference laboratory in Maywood, N.J. A kit version of AlzheimAlert is also available for sale in Europe as a result of its certification with a CE Mark, making the test kit eligible for sale in the European Union.