Medical Device Link.

Originally Published IVD Technology April 2004

INDUSTRY NEWS

With the number of people diagnosed with Alzheimer’s disease expected to increase as the baby boom generation continues to age, a good, reliable IVD test for early detection of Alzheimer’s is desperately needed. However, such an IVD has yet to be developed and commercialized. Recent progress in the IVD industry could eventually lead to the development of diagnostic tests for Alzheimer’s.

Until now, there have been considerable efforts to develop diagnostics for Alzheimer’s disease. For the most part, these development efforts targeted certain pathological criteria found either in the middle or toward the end of the disease’s progression and using those as diagnostic parameters. Most of these efforts have focused on looking at ways to detect pathological elements such as amyloid beta, tau proteins, and apolipoprotein E genotypes. 

Unfortunately, these efforts have met with limited success. The problem primarily stems from the fact that the pathological criteria being targeted are also present in normal aging as well as other neurodegenerative diseases. They lack the sensitivity and specificity to detect Alzheimer’s disease and have limited clinical utility.

Consequently, some companies have been looking into alternative methods to detect and diagnose for Alzheimer’s disease. Nymox Pharmaceutical Corp. (Maywood, NJ) filed a premarket approval application with FDA for its Alzheimer’s urine test. The company’s AlzheimAlert is a noninvasive urine test that is intended to help in the diagnosis of Alzheimer’s. The test measures the level of a brain protein called neural thread protein (NTP) that is known to be elevated in the urine of Alzheimer’s patients.

However, analysts expressed skepticism about the effectiveness of Nymox’s diagnostic for Alzheimer’s disease. These analysts said that there has been no independent replication by any research group to validate and confirm Nymox’s claims regarding the usefulness of NTP (also known as AD7C) as a marker for diagnosing Alzheimer’s. 

Nymox officials declined to comment for this story.

At the same time, CombiMatrix Corp. (Mukilteo, WA) signed a collaborative research agreement with Case Western Reserve University (Cleveland) to develop a diagnostic for Alzheimer’s disease. Under this agreement, researchers will conduct experiments using CombiMatrix’s CustomArray platform. 

“We have a hypothesis that there are novel pathways that are involved in the initiation of the disease,” says Mark A. Smith, PhD, a professor in the department of pathology at Case Western Reserve University. “By targeting these pathways, we are hoping that we can come up with a much more sensitive way of diagnosing the disease at the earliest possible point.”

Smith added that, “We hope to develop a minimally invasive diagnostic that is based on parameters that would be unique to Alzheimer’s disease, rather than parameters that are shared between Alzheimer’s disease and normal aging.” 

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