The technology developed is based on the two quantification methods (ELBA and TDR), both clinically validated and patented (owned by INFN) with Italian coverage, but it is expected to be extended to a European level and to other countries. Currently, the desktop application that will make our solution accessible is functional and available for research use only.
The market segment in which the product refers is that of the dementia diagnostics;
in particular, the global market for Alzheimer’s disease diagnostics and therapeutics.
This market is valued at USD 7,537.4 million in 2018, and it is estimated that the valuation will grow
to USD 11,140 million in 2024, witnessing a CAGR of 6.7% (ResearchAndMarkets.com).
Alzheimer’s disease diagnosis market can be segmented based on:
- Stage of disease development: early-onset Alzheimer’s disease, familial Alzheimer’s, late-onset Alzheimer’s
- Diagnostic test: neurological exam, genetic test, Mini Mental State Exam (MMSE), and brain imaging
- End-users: diagnostic centers, hospitals, and clinics (including the so-called UVA, Alzheimer’s Assessment Units)
- Clinical Trials / Pharmaceutical Companies
An estimate made by the company Amyvid, manufacturer of one of the three radiopharmaceuticals for amyloid PET, assumes to reach an annual turnover of 60M USD from the sale of the tracer.
Given an approximate cost of USD 1600 per single vial of tracer, the number of amyloid PETs performed each year would be approximately 37500. Assuming the estimate also valid for the other two tracers on the market, the annual number of amyloid-PET tests would be just over 112,000 per year.
Initially, the service will be addressed to the analysis of the latter type of exams and one can reasonably expect to be able to cover 1% of the total.
To these can be added the number of scans resulting from the estimated number of new Alzheimer’s cases of 10 million by 2030 (World Alzheimer Report 2015 – The Global Impact of Dementia).
The prevalence of neurodegenerative diseases (the so-called “dementias”),
especially Alzheimer’s disease (AD), is rapidly growing and the number of affected
people is estimated to double by 2050.
To date, the diagnosis of AD is done when clinical symptoms occur, that is, in a very
advanced stage of the disease. However, there is an abundance of confounding
factors (such as depression or lack of sleep) and symptoms of concomitant diseases (for example, the various forms of Parkinsonism or Levy’s body dementia) that make this assessment difficult.
It’s known that structural brain imaging (MRI) or even more functional (PET) brain imaging techniques can bring useful information for the prediction of the onset of symptoms (the “conversion to disease”) and the anticipation of diagnosis in a purely asymptomatic stage of the pathology.
An instrument such as PET with the tracer for amyloidosis (amyloid PET), although difficult to interpret, is the only non-invasive method capable of visualizing the accumulation of beta-amyloid protein in cortical tissue, considered as one of the first events in the degenerative process of the brain, making the diagnosis of Alzheimer’s disease even several tens of years in advance.
These images are assessed only qualitatively through a visual inspection and, due to the difficult interpretation, their use in the clinic is greatly reduced, despite the enormous advantages: this examination is often ignored for fear of errors.
It’s estimated that cases of misdiagnosis in hospital routines are around 30%, with the understandable inconvenience for patients, family members, and caregivers, as well as additional costs for the hospital system.
This percentage can be drastically reduced thanks to the systematic use of PET imaging and supporting the clinicians with an accurate quantitative analysis of this examination, as suggested by the most recent guidelines.
Current technologies limits
The standard quantification procedure for amyloid PET images is the Standardized Uptake Value ratio (SUVr), based on the comparison between anatomical regions clinically affected by amyloid accumulation: all software currently on the market are based solely on this technique.
The quantification with SUVr is affected by many sources of error (such as the quality of the data) and, for this reason, the result is limited to a dichotomous classification (negative/positive) of subjects: therefore this analysis is inadequate for a thorough reporting procedure, as well as for accurate patient follow-up.
In addition to the limitations of the technique, none of the solutions are optimized on all amyloid tracers on the market.
Furthermore, some software is supplied together with the dedicated workstation that binds its use and does not adapt well to the diagnostic process.
There are many analysis services on the market for other types of neuroimaging data (MRI or non-amyloid PET) that provide information on the degenerative process, but with less advance on the onset of symptoms and less specificity than amyloid PET, not allowing differential diagnosis of AD.
The amyloid PET image analysis service will be accessible to customers through a multi-platform desktop application that will enable the sending of data, in compliance with the GDPR, for their remote analysis and will allow results reception and display.
The application is in an advanced stage of development and, at present, is ready for use for research purposes only.
The service is designed to be easily integrated into the workflow of medical staff in various fields: from clinical neurological and nuclear medicine routine to scientific research up to the monitoring of clinical trials for anti-amyloid treatments.
The growth of the business will see complementing the current offering
as a fundamental key by the implementation of new analysis pipelines
for other imaging modalities (as MRI and DAT-SPECT),
making them available through the same desktop application.
Technology and our solution
The proposed technology is an automated quantitative analysis service of brain amyloid PET imaging with two patented (owner: INFN), published, and clinically validated innovative methods: EvaLuation of Brain Amyloidosis (ELBA) and Time-Delayed Ratio (TDR).
These new algorithms give independent results because they study different image characteristics: ELBA provides a quantification extracted from the geometry of the signal, while the TDR includes in the calculation the cerebral flow and therefore the pathophysiological characteristics of the individual subject.
Thanks to their independence, the obtained results are finally combined (also with the SUVr analysis) to obtain a single index that is more robust than the individual methods.
The combination of different analysis techniques that are equally validated at the clinical level is the hallmark of our technology.
Our analysis supports all the commercially available amyloid tracers and allows both global and region-specific quantification.
The service is made available through a desktop application, provided to the user, and installed locally, which allows them to perform remote image analysis and return the results report in a short time.
The use of amyloid quantification results as a support to the diagnosis would reduce the risk of error, thus guiding the clinician in choosing the best therapeutic path for the patient.
Furthermore, our approach wins the weaknesses of every single quantification technique, guaranteeing a single robust and reliable index: this value can be used as an index of disease severity and leads to the overcoming of the current dichotomous classification, allowing to place the patient on a continuous comparative scale.
Thanks to this result, all subjects identified as borderline by the previous classification (about 30% of all patients) are better characterized, and is possible to accurately observe changes in the condition of the subjects over time.
The benefits of a more reliable and earlier diagnosis are undoubtedly fruitful, improving the life quality of patients, their families, and caregivers, and allowing the selection of those at risk with the consequent administration of anti-amyloid treatments or aimed at soothing the symptoms of the pathology to the correct subjects.
The method of accessing the service makes the analysis transparent to the user who is familiar with the “upload-process-download” web paradigm.
This paradigm conforms to the workflow of medical staff (both in clinical routine, as well as in clinical research and trials) and it comes in a full-proof cross-platform solution that does not require dedicated hardware or personnel, thus bridging the gap formed between medical research and clinical practice.
Initially, a major promotion of the product will be necessary to increase its use in research and provide a training environment for clinicians: for this purpose, interaction with European research consortia and associations (AIMN, Italian Association of Medicine Nuclear; EANM, European Association of Nuclear Medicine; EADC, European Alzheimer’s Disease Consortium) with which the group is already in close contact.
Subsequently, it will be necessary to obtain the ISO9001 and CE certifications as a medical device for the platform and the analysis pipeline: this operation is necessary to make it possible to market the product.
The final goal will be the official release of the desktop application, expected by the end of 2021, initially in the Italian market and in a second phase in the European one, taking advantage of the previous distribution of the platform for research purposes to attract potential customers.
Later, new analysis pipelines will be implemented for other imaging techniques, which will follow the same development path as the analysis for amyloid PET, to be added to the platform offers.