Medical Device Daily National Editor

Medical research is essentially a merry-go-round, the riders constantly reaching for the difficult-to-grasp brass rings (or in this case, gold). Such as developing devices for understanding the activity in a cell, or for hearing the off-beat symptoms of a troubled heart; discovering anesthetics, to enable surgery, and vaccines, to stave off disease; developing the devices and drugs producing outright cures – but many are elusive, even illusory.

Diagnostics has collected a host of breakthrough testing achievements, but one remains distressingly out of reach: a definitive test for Alzheimer's disease, one that can truly validate the earliest symptoms so as to guide treatment for ameliorating its worst effects.

As of now, short of autopsy and the examination of a person's brain, there is no definitive determination of Alzheimer's – only an informed guess concerning a group of symptoms.

In what may be the achievement of this important goal, or simply another elusive grasping, Power3 Medical (Houston) yesterday issued a preliminary report on a 300-patient study indicating the identification of Alzheimer's in 95% of cases.

The company provided what it termed a "status report," saying that its NuroPro test – using protein biomarkers in blood serum — has been confirmed as having the ability to identify Alzheimer's in a large majority of cases in a 300-patient study.

That validation is "north of 90%," Steven Rash, CEO of Power3, told Medical Device Daily, saying that the data looked at thus far in the study offers "wonderful news" for the company and "better than anticipated."

Well, maybe.

Even if the data ultimately demonstrates the 95% accuracy, some may question the study protocol – the use of a control group, not of individuals deceased and autopsied as having Alzheimer's, but defined by a clinical expert as having the disease.

Rash said that the company is comparing its biomarker analyses "with the clinical diagnosis" of patients made by Dr. Marwan Sabbagh, director of clinical research at the Cleo Roberts Center of Clinical Research at the Sun Health Research Institute (Sun City, Arizona), lead investigator in the study.

And Rash emphasized Sabbagh's expertise in the understanding of Alzheimer's and the certainty of his diagnosis as providing an adequate control methodology.

The company said it plans to publish the final data from the 300-patient study before the year is out and then begin commercialization.

Whether highly positive data from the study will convince customers of the test's validity is likely mostly a marketing question, since the company does not have to seek FDA clearance.

FDA okay is unnecessary, Rash noted, since the test initially won't be sold to other labs for analysis but will be analyzed in the company's own CLIA-certified laboratory.

However, he said that the company has begun discussions with the FDA, as a matter of seeking "guidance," and that longer-term plans call for negotiating the agency's hoops and hurdles to enable broader use of the test.

The test uses protein biomarkers, with Rash emphasizing that the company analyzes a "panel" of these for determination of Alzheimer's as well as Parkinson's.

What are these biomarkers?

"That's the question everyone wants to know," Rash said, declining also to provide this information exclusively to MDD as well.

He said the company uses 59 biomarkers, with a variety of patent applications for them in the works, but "I can't tell you the name of them." They are "differentially expressed from the norm," that work "in tandem with one another," he said, and then analyzed by the company's system to create a disease profile.

Study leader Sabbagh described the preliminary results for the test in the 300-patient study as "very promising" and thus good news for clinicians seeking a "tool to diagnose and treat Alzheimer's earlier and therefore give the best care to their patients."

He reported that 92 Alzheimer's and control patient samples have been analyzed in Power3's laboratory, demonstrating high sensitivity and specificity in the diagnosis of Alzheimer's.

Dr. Essam Sheta, director of Power3's laboratory, said that the data from the 300-patient study so far shows the test's "superior sensitivity and specificity with results in the 95% range."

He added that the study "validates Power3's collection, storage, shipping, processing and biostatistical analysis methods."

Rash said that the company is planning to expand on validation of the NuroPro to two additional clinical sites in the U.S. and that "[l]arger patient cohorts of different ethnic and environmental backgrounds will strengthen the validity of NuroPro's applicability in the diagnosis of neurodegenerative diseases."

"This study," he said, "confirms that Power3 is rapidly approaching the stage to commercializing the first-ever blood serum proteomic tests for the diagnosis of neurodegenerative diseases. ... [and] offer a means to detect neurodegenerative diseases at their earliest stages, allowing physicians to begin treatment at stages which will produce more positive outcomes."

He said that the company also is pursuing an ongoing Parkinson's validation study under the direction of Dr. Katerina Markopoulou at the Research Institute at the University of Thessaly (Thessaly, Greece). It said it expects to conclude the Parkinson's study in September and publish the results soon after.

Sun Health Research Institute is focused on researching concerning the disorders of aging. Together with its Arizona Alzheimer's Consortium partners, it has been designated by the National Institutes of Health as one of just 31 Alzheimer's Disease Centers in the nation.