What is known is that the test is based on 2D gel electrophoresis followed by quantification of the protein markers. Rash admitted that most commentators are a little surprised at the choice of methodology. Two-dimensional gels are not as sensitive as more modern proteomics methods or immunoassays, but the company claims they can detect as little as 0.23 ng of protein. “With 2D gel we get great specificity, sensitivity and reproducibility. We have strict collection and handling protocols, and very strict SOP [standard operating procedures] within our facilities,” said Rash. The company recently received CLIA approval (the Clinical Laboratory Improvement Amendments program is run by the Center for Medicare and Medicaid Services), which is necessary for any non-research diagnostic testing performed on humans in the U.S. In 2006, researchers at the company published their basic approach, showing that proteins of the immune/complement system contributed to disease profiles for both PD and ALS (see Goldknopf et al., 2006 and Sheta et al., 2006). It is not clear if the 59-protein panel contains these same markers.

NuroPro is currently undergoing validation in the U.S. and also in Greece. The U.S. study is being conducted at Sun Health Research Institute, Sun City, Arizona, under the direction of Marwan Sabbagh and will test a total of 300 subjects, including controls, AD, and PD patients. The Greek study is lead by Katerina Markopoulou from the University of Thessaly Medical School in Larissa. According to Rash, Markopoulou contacted the company after reading their initial findings. “We’ve been very happy with that collaboration. Dr. Markopoulou does great clinical evaluations and we are getting some very interesting data,” said Rash.

The validation studies are scheduled to be completed later this year, and the company hopes to start selling the test by the end of 2008 in Greece and the U.S., according to its press release. In addition to helping clinicians with diagnosis, Rash hopes the test will help doctors correctly identify patients and controls for clinical trials. “We can also monitor patient progress on a quantitative basis to see if the biomarkers are coming back closer to the norm,” he said. That potential may interest drug developers, as may some of the markers in the panel, which could turn out to be potential drug targets themselves. The research community eagerly awaits data to peruse. Other blood-based diagnostic tests that are at various stages of research and validation include one by the Norwegian company DiaGenic, one by the Belgian company Innogenetics, and one by the Californian startup Satoris (see ARF related news story).—Tom Fagan.