The Immunology Devices Panel met on Friday, July 15, 2005 in Gaithersburg, Maryland to provide advice and recommendation to the Food and Drug Administration regarding a premarket approval application (PMA P040010) for the Nymox Urine Neural Thread Protein (NTP) Test kit.
The Nymox Urine NTP kit is intended to measure neural thread protein in urine specimens from patients presenting with cognitive complaints or other signs and symptoms of suspected Alzheimer’s disease (AD). Results from the Urine NTP kit are intended for use in conjunction with and not in lieu of current standard diagnostic procedures, to aid the physician in the diagnosis of Definite Non-AD versus Probable AD, Possible AD or MCI (Mild Cognitive Impairment).
A written comment was read into the minutes by a representative of the Alzheimer’s Association Medical and Scientific Advisory Council indicating that the association does not support the use of the test for either diagnosing or “ruling out” Alzheimer’s disease.
The sponsor and FDA presented their pre-clinical and clinical study data to the advisory panel. After deliberation, the panel voted five to two for non-approval of the Nymox NTP test. The panel’s vote was based on the majority opinion that the data presented by the sponsor did not demonstrate a reasonable assurance of safety and effectiveness for the intended use of the device.
All the panel members explained the reasons for their vote.
The panel members offered advice to the sponsor on the deficiencies in the Nymox-sponsored studies and recommendations for the types of scientific information that might help Nymox better demonstrate the performance characteristic of their device. The suggestions included the need for a pre-defined hypothesis, study sample of sufficient size, use of a biomarker model, longitudinal follow-up studies to validate the performance of the test, and collection of biovariability data for NTP, the need to validate the NTP test with the class of patients known as possible Alzheimer’s disease, the possible harm to patients from a negative and positive result by the NTP test, and concerns about the feasibility of collecting first-morning urine samples from patients in a non-clinical trial setting.
Contact: Rufina Carlos, Executive Secretary, at 240-276-0493 ext 167 or firstname.lastname@example.org.
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