Urine AlzheimAlert™ Test: Clinical Summary
The AlzheimAlert™ Test is the only accurate painless urine test available to assist a physician in the diagnosis of Alzheimer's disease (AD). It measures the level of a biomarker for AD, neural thread protein (NTP), in urine. It is not a genetic test. Clinicians across the United States have been using NTP testing since 1996, first in a cerebrospinal fluid (CSF) version and now in a urinary version. Its efficacy has been proven repeatedly in the clinical setting (see the Bibliographic References).
An accurate clinical diagnosis of AD is crucial for patients and their families. It enables them to make informed social, legal and medical decisions and allows treating physicians to take advantage of new improvements in drug treatment and care. Even a modest delay in institutionalization can mean huge social and financial savings. Conversely, ruling out AD eliminates the tremendous uncertainty and anxiety patients and their families would otherwise face and allows physicians to focus on the other, often reversible, causes of cognitive changes. For the health care system, diagnosis with the aid of the AlzheimAlert™ Test represents a potentially large cost-savings in terms of repeated office visits, lab tests, scans and other procedures required by the traditional methods of diagnosis.
What does the AlzheimAlert™ Test measure?
The AlzheimAlert™ Test measures the level of neural thread protein (NTP) which is elevated early in AD as reported both in the peer-reviewed literature and at scientific conferences (see the Bibliographic References). Research teams at the Massachusetts General Hospital, Harvard and Brown University first found NTP in the brains of patients with AD in large amounts associated with the pathological hallmarks of the disease. The protein has been characterized and measured in brain tissue, CSF and urine (see the Bibliographic References). There is evidence that NTP is involved in neuronal cell death and neuritic sprouting, both of which are characteristic of AD (see the Bibliographic References). The NTP level correlates with the severity of the dementia ( see de la Monte (1997), Kahle (2000) and Munzar (2002) in Bibliographic References). NTP is the only biological marker for AD that correlates with cognitive decline.
How is the AlzheimAlert™ Test performed?
The test is a competitive immunoassay that measures the level of NTP in the urine of a patient. A first morning, midstream urine sample of 50 ml is required. The turnaround for the test is usually five working days from when the specimen is received until when the results are reported to the physician.
What is the clinical significance of the AlzheimAlert™ Test?
A reading of more than 22 ug/mL in urine is abnormal and closely correlates with AD. Based on multiple independent coded double blind clinical studies, NTP has been proven to be a highly sensitive and specific biomarker for AD. In studies to date, the AlzheimAlert™ urine test has a sensitivity of over 80% and a specificity of 90% (see Bibliographic References).
Its accuracy compares favorably with other standard tests such as routine urinalysis for urinary tract infection or PSA for prostate cancer. The gold standard for the diagnosis of AD - postmortem histopathologic examination of the brain by a certified specialist - is only between 84% to 92% reliable based on comparisons between postmortem diagnoses by different specialists. There is no other antemortem, non-invasive or painless biomarker for AD that has the accuracy, sensitivity, or specificity of NTP.
The AlzheimAlert™ Test is a valuable aid to a physician because it measures an early and accurate marker of AD. The diagnosis of AD is often one of exclusion, taking on average three years from the time of initial symptoms until a diagnosis is reached. This exclusionary process is often time-consuming, expensive, and frustrating to the patient and his or her family who face the prospect of making difficult social, economic and legal decisions. New drugs like Aricept™, Razadyne™, Exelon™ and Namenda™ are available to treat AD.
The AlzheimAlert™ Test is meant as an aid to clinical diagnosis and not as a substitute for a physician's clinical judgment based on all the relevant medical history, tests and examinations of the patient.
What are the appropriate billing codes for the AlzheimAlert™ Test?
The appropriate CPT code for the urinary version is 81099 and for the CSF version 86849. The appropriate ICD-9-CM diagnostic code is 331.9.
Is the AlzheimAlert™ test approved or certified?
The AlzheimAlert™ Test is certified to be performed in Nymox's CLIA-certified Clinical Reference Laboratory (CLIA ID #21D0917550). This service does not require FDA approval. Stringent quality control is required by the Federal CLIA (Clinical Laboratory Improvement Amendments) regulations and the Centers for Medicare & Medicaid Services (CMS). State laws and regulations restrict the persons who may order the tests to qualified physicians.
For further information about the AlzheimAlert™ test or copies of the published papers on NTP and its use as an aid to the diagnosis of Alzheimer's disease, please call Nymox Corporation at 1-800-93NYMOX (1-800-936-9669).
