One week after it said it had found biomarkers with potential application for Alzheimer’s disease diagnostics, Power3 Medical Products last week said it has identified 11 biomarkers that could be use to diagnose Parkinson’s disease.
The biomarkers may also allow researchers to differentiate Parkinson’s from other neurodegenerative diseases, the company added.
In August, Power3 announced it had found five biomarkers with the potential to diagnose Alzheimer’s disease, and in an interview with ProteoMonitorthis week, Steve Rash, Power3’s chairman and CEO, said that it may be ready to launch a diagnostic test based on that research within “90 to 120 days.”
If successful, Power3’s product would be the first blood-based Alzheimer’s test on the market. The company said it is currently seeking a manufacturing and marketing partner for the Alzheimer’s test.
Power3 is now trying to validate the Parkinson’s biomarkers in further studies encompassing about 500 samples. The company said that a “major European research institution” and a “leading expert” in the study of neurodegenerative diseases will be involved in the validation process studies.
Officials declined to identify the company or individual, but in an introduction letter to potential investors Power3 said that it has research agreements with Pfizer and Innogenetics for biomarker discovery in the area of neurodegenerative diseases.
“The new protein biomarkers identified by Power3 represent a promise for early detection and identification of Parkinson’s,” Rash said “With earlier detection — and differentiation from Parkinson’s-like diseases — should come earlier and more effective treatment.”
According to the National Parkinson’s Foundation, 1.5 million Americans currently have Parkinson’s and an additional 60,000 Americans are diagnosed each year with the disease.
Currently there is no blood test for the disease and diagnosis is primarily done through tests such as MRIs, physician observation, and a process of eliminating other possible illnesses.
Power3’s Parkinson’s announcement came one week after it said it had found five biomarkers with greater than 90 percent sensitivity in identifying patients with Alzheimer’s disease. The biomarkers were found from a portfolio of 47 biomarkers previously identified for neurodegenerative diseases, the company said.
For both the Parkinson’s and Alzheimer’s research, Power3 chose to base its testing on serum rather than cerebrospinal fluid in order to facilitate access to samples, said Essam Sheta, Power3’s director of biochemistry. That approach, however, presented its own obstacles.
“The challenge of using serum for biomarker discovery is the fact that a few protein classes, including albumins, immunoglobulins, transferrins, haptoglobins, and a few others, constitute more than 80 percent of the protein content of the serum sample,” Sheta and fellow researchers Stanley Appel and Ira Goldknopf wrote in a research paper published earlier this year in the journal Expert Review of Proteomics. “Consequently, it becomes a genuine challenge to find low abundance proteins, and in some instances, sample enrichment is required, causing the possible risk of losing the candidate proteins during the process of enrichment.”
Power3 used 2D gel electrophoresis followed by image analysis to find the Parkinson’s biomarkers by identifying which “protein spots were different between the two compared groups,” Sheta said.
Of the potential Alzheimer’s test, Rash said, “We are ready to go. This test works,” he said. About 4.5 million Americans have Alzheimer’s, according to the Alzheimer’s Association, with that number expected to climb as high as 16 million by 2050.
Last week, however, the US Food and Drug Administration released a draft guidance that could require makers of homebrew tests such as Power3’s anticipated Alzheimer’s test to undergo regulatory approval instead of following traditional CLIA guidelines [see related story, this issue].
Rash said that guidance, if formalized, won’t take effect for two years, however. An FDA official said the agency has not yet decided what steps to take with existing or impending tests.
In addition to Power3, companies such as Oxis International and Knopp Neurosciences have been engaged in biomarker research for neurodegenerative diseases. And last month researchers from Oregon Health and Science University in Portland, Baylor College of Medicine in Houston, the Fred Hutchinson Cancer Research Center, and Applied Biosystems published a study in the Journal of Alzheimer’s Disease saying they had identified biomarkers for neurodegenerative diseases including Parkinson’s and methods of differentiating one neurodegenerative disease biomarker from another. [See PM 08/17/06].
Based in The Woodlands, Texas, Power3 licenses its biomarkers to diagnostic companies to develop antibodies, immunoassays, and ultimately diagnostic tests. Its sole existing licensing deal is with Biosite for the development of a breast cancer diagnostic, though it has numerous research agreements, Rash said.
“We consider ourselves more of a biomarker factory,” he said. The company currently has about 520 biomarkers, he added.