Clinica's MedTech Ventures: NeuroVision Imaging

Clinica’s MedTech Ventures: NeuroVision Imaging
Specialty area(s): Alzheimer’s disease diagnostics
Based in: Sacramento, California, US
Founded in: 2010
No. of employees: 10
Total investment received to date: Around $4.5m
Investors: Undisclosed
The recent media interest in a blood test in development for Alzheimer’s showed that diagnostics are becoming increasingly important in the disease. As the hallmark brain damage occurs long before symptoms begin, detecting the disease early is vital for its successful treatment. Earlier detection could also help recruit the right patients to clinical trials and increase the likelihood of disease-modifying drugs making it to the market.
But while blood testing has been grabbing the headlines of late, California company NeuroVision Imaging has developed a test that looks for amyloid in the retina, which could be available for clinical use sooner – and could bridge the gap between current PET imaging agents and future blood-based diagnostics.
Other firms, such as Cognoptix, are investigating the eye, specifically the lens – but NeuroVision CEO Steven Verdooner believes the retina “more faithfully represents the brain, being a developmental outgrowth of the central nervous system and being vascularized. We think it’s a better target.”
Sacramento, California-based NeuroVision reported preliminary results with its retina test at the recent Alzheimer’s Association International Conference (AAIC), held in Copenhagen, Denmark on 12-17 July.
The data, from 40 patients in a 200-patient study, found that beta-amyloid levels detected with the firm’s technology “significantly correlated” with beta-amyloid levels in the brain measured using PET imaging. Furthermore, the retinal amyloid imaging test differentiated between Alzheimer’s and non-Alzheimer’s subjects with 100% sensitivity and 80.6% specificity.
The company plans to complete the trial by the end of the year and hopes to get 510(k) clearance from the US FDA “in a little over a year from now,” Mr Verdooner told Clinica. CE marking in Europe should come at around the same time, he added.
While the current study is not a formal regulatory trial, the results obtained should be enough to gain approval, the company hopes. “It comes down to what label claims you make,” the CEO said. “Even the PET probes don’t make specific claims with respect to the diagnosis of Alzheimer’s disease. We’re trying to keep things simple and have a device that goes through the approval process, that doesn’t get overly aggressive with its claims, and that allows scientists and clinicians to further validate [it].”
While NeuroVision’s test and current amyloid-binding PET agents such as Lilly’s Amyvid and GE Healthcare’s Vizamyl both detect beta-amyloid plaques, Mr Verdooner believes his company’s technology has several potential advantages over PET. This includes it being less invasive than PET, being repeatable, as well as having the capability to detect discreet plaques at a better resolution.
“With PET scans you’re injecting a radioactive probe, and the resolution only goes down to maybe 1-2mm, because you’re imaging the whole brain
“Our test uses curcumin, the core of the Indian spice turmeric, which is generally regarded as safe  by the FDA. It has an extremely high affinity to amyloid-beta plaque, and it’s not radioactive, but it fluoresces. We’re imaging this fluorescence in the retina after the patient takes curcumin orally. And we’re directly imaging amyloid-beta plaques on the order of about 20 microns. So we have the ability really to see very fine plaque detail in the retina.”
He concluded that NeuroVision’s test is “noninvasive, very fast and very safe. It’s very much like having a retinal photograph done at your ophthalmologist.”
The diagnostic could therefore open up the possibility of monitoring patients over time with repeated tests to measure disease progression, which is not possible with PET imaging and other techniques such as cerebrospinal fluid (CSF) testing, which requires a lumbar puncture to collect the fluid. “It’s not practical to do multiple CSF lumbar punctures or multiple PET scans over long periods of time,” Mr Verdooner
Long-term monitoring could be of interest to pharma companies, who want to check whether their drug is working, as well as measuring drug response in the clinic. “We can potentially see if there’s [beta-amyloid] clearance or change in the rate of accumulation,” he explained. “We hope to play an important role in looking at response to therapy.”
So apart from clinical trials and patient monitoring, how does NeuroVision see its test being used? “I think it will certainly play a role in differential diagnosis,” the CEO said. “I don’t envision population screening, but I think it could be used in the at-risk population. We know that people who have a family history of Alzheimer’s are at much greater risk.”
But NeuroVision isn’t sounding the death knell for Alzheimer’s blood testing, Mr Verdooner stressed. “I think they can co-exist. As a general rule, the problem with blood tests has been specificity. But the UK group [comprised of King's College London and Proteome Sciences] and others have made progress. And we’ve already licensed the rights to some blood-based biomarkers, because we think the combination is what will improve the diagnostic accuracy.”
Steven R Verdooner, CEO. [email protected]
NeuroVision Imaging LLC, 1395 Garden Hwy Ste #250, Sacramento, CA 95833, US.
www.neurovision.com