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Optina Diagnostic
Location: 7405 Transcanadienne Highway, 330, Montreal, Canada Canada
Founded in: 2016
Stage: Post-launch
Number of employees: 16-30
Funding history:
- Date: 09/2018, Series A: $15 M (post valuation: undisclosed amount).
Short URL: vator.co/optina-diagnostic
Followers (12)
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Optina Diagnostic

Startup/business
Montreal, Canada Canada
http://www.optinadx.com
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Company description

Optina Diagnostic technology enables a simple eye-scan to detect key biomarkers of cognitive diseases, using specialized hardware and proprietary A.I. software, focusing first on Alzheimer’s disease. Optina’s eye scanning technology will slash pharma trial recruitment costs, improve patient diagnostics and management of cognitively-impaired aging populations, eventually available to screen anyone over 60 to help prevent cognitive diseases. Optina is currently operational at five clinical sites, have raised $4.5M in equity, $4M in grants.  Optina will be raising $15M in 2019.


Team
  • Claudia Chevrefils
    Claudia Chevrefils | Founder
    I am an experienced biomedical engineer with in depth knowledge in artificial intelligence, design of validation protocol, proof of concept, generation of relevant and comprehensive engineering report. Through more than a decade I was involved in ...
  • David Lapointe
    David Lapointe | Founder
    An entrepreneur by nature with a keen eye for identifying opportunities. Results-oriented with a mission to benefit the advancement of the healthcare industry with a ROI for stakeholders.
  • Marie-Claude Marchand
    Marie-Claude Marchand | Team member
Business model

Distribution through eye clinic

Per scan revenue

Patient management telemedicine to capture revenue from change in patient management (50% revenue split with partner)

Data collection for deep learning to academic revenue sharing

Competitive advantage

 

Competitive analysis

 

 

 

Market

Readiness

Access

Non

Invasive

Low

Cost

Specificity

Sensitivity

Stratification Potential

Optina

+++

++++

++++

++++

++++

++++

CSF

+++

++

+

++

++++

+++

Blood

+

+++

+++

+++

++?

+++

Ab-PET

++++

++

++

+

++++

++

 

General Positioning.

In current clinical practice, the Optina scan improves patient management of MCI and probable AD subjects. Indeed, recent studies are supporting the benefits of amyloid status knowledge for the diagnosis and management of patients with cognitive impairment [Boccardi et al., JAMA Neurol, 2016; Grundman et al., Dement Geriatr Cogn Discord, 2016]. The diagnosis based on clinical symptoms was changed in more than 25% of cases (and more than 50% in MCI) after the addition of the amyloid status, and consequently the management plan for these patients was adapted accordingly. Models are now becoming available to evaluate the prognosis (e.g. 1-year and 3-year) of individual MCI patients based on cognitive assessment and biomarkers such as amyloid status [Van Maurik, AAIC 2017], paving the way to risk assessment on an individual level in the near future.

The Optina scan is the first line, low cost, accessible, non-invasive screening test to identify the presence amyloid and other biomarkers. Further patient characterization can be done by brain imaging and CSF. Moreover, the Optina scan is used by pharma companies to identify asymptomatic subjects at high risk of developing AD for clinical trials.

 

The following comparison is based on the identification of cerebral amyloid pathology, a key hallmark of AD.

 

Market readiness

Optina

The Optina scan can be deployed rapidly as it does not rely on complex chemistry and laboratory work tedious to implement. The Optina cloud-based computing algorithm can be easily scaled up, while the retinal camera manufacturing and distribution can be undertaken by a large ophthalmic instrument manufacturer.

 

CSF

The core CSF biomarkers of neurodegeneration (Ab42, P-tau and T-tau) are strongly associated with AD and well established for research purposes [Olsson et al., Lancet Neurol, 2016]. However, standardization efforts for the quantification of the CSF biomarkers are still required to reach market [Kuhlmann et al., Clinica Chimica Acta, 2017].

 

Blood

The association of blood Ab with AD remains questionable [Olsson et al., Lancet Neurol, 2016; Lövheim et al., Alzheimers and Dement, 2017]. A recent study suggests that 30-50% of amyloid found in blood could originate from the central nervous system [Ovod et al., Alzheimers Dement, 2017], meaning that the other sources could prevent the observation of a correlation between the two compartments. Moreover, a major challenge for developing a blood test is that the proteins of interest are at much lower concentration in blood than in the CSF (by a factor of 50-250), meaning that very sensitive approaches are required [Blennow et al, Neurol Ther, 2017] and that the standardization of the analytical method represents an important challenge for commercialization [O’Bryant et al., Alzheimers Dement, 2017]. By the time blood test are developed, validated and ready for commercialization, the Optina scan will already well established.

 

Ab-PET

Ab-PET (Amyloid PET) is already on market since 2012 (3 tracers now available) and is paving the way to demonstrating the impact of amyloid biomarker in drug development and patient management [Boccardi et al., JAMA Neurol, 2016; Grundman et al., Dement Geriatr Cogn Discord, 2016; Donohue et al., JAMA Neurol, 2016]

 

Access

Optina

In clinical practice, the test will be prescribed by the referring physician. Through the Optina online platform the patient will be directed to an eye scan location which includes eye clinics that are located in highly accessible area and eye clinics that are co-located with a medical general practice. General practitioners already refer diabetic patients to eye clinics for yearly eye exam. Moreover, a large proportion of the target population (> 40%) already consults an eye specialist on a yearly basis and are therefore familiar with retinal imaging. In the longer term, a fully automated version of the Optina imaging system could also be offered in various points of care such as pharmacies.

                                            

CSF

Requires qualified personnel and appropriate facilities for the lumbar puncture procedure. The fluid analysis need to performed by highly qualified personnel and requires very sensitive analytical methods and expensive equipment

 

Blood

Blood tests are common in clinical practice and multiple clinics and health centers already offer blood withdrawing services. The blood analysis, similarly to the CSF analysis, requires highly qualified personnel, very sensitive analytical methods and expensive equipment which could limit or slow the market penetration.

 

Ab-PET

Requires expensive infrastructure and highly qualified personnel.

 

Non-invasive

Optina

The eye scan requires no injection, radioactive tracer or contrast agent, and it is completely non-invasive. It consists in simple eye imaging test lasting only a few seconds as part of a routine eye exam.

 

CSF

Requires a lumbar puncture to collect the fluid.

 

Blood

Requires a blood draw. The procedure is common and considered minimally invasive. However, geriatric patients often have medical conditions that make blood collection difficult, such as arthritis, hearing loss, atherosclerosis, dementia, etc. In addition, their skin commonly becomes thinner and looser; the muscles also become smaller, causing veins to roll easier; and they are also at an increased risk of hypothermia.   Most importantly, their veins become less elastic and can be easily injured or collapse during a venipuncture. Finally, a survey revealed that over 20% of the adult population would avoid needles if they could [Wright et al., Australian Family Physician, 2009].

 

Ab-PET

Requires the injection of radioactive tracer before the imaging session.

 

Low cost

Optina

The revenue model supports a price of 400$ per subject at the beginning, including a 200$ fee for the eye clinic conducting the test (Technical and professional services) and 200$ per patient for the equipment and data analysis (Optina revenue). Eventually, as the procedure is automatized and the volume of scans increases the revenue model could support a price of 50-100$ per scan.

 

CSF

Estimated price between $400-1000 per subject to cover for the lumbar puncture procedure and complex analytical method costs.

 

Blood

Estimated price between $300-900 per subject to cover for the complex analytical method costs.

 

Ab-PET

The procedure typically costs approximately $5000-8000 due to the high cost of the tracer dose and PET imaging procedure. Considering that the production of the tracer requires a cyclotron, it is unlikely that an increase in production volume would result in a significant decrease of the cost.


 

Specificity and sensitivity

Optina

The ongoing study looking at the correlation between the retina scan and Ab-PET scan achieved target sensitivity and specificity >90% in predicting the PET amyloid status.

 

CSF

Multiple studies support the high diagnostic accuracy for AD and MCI of the AD core CSF biomarkers with reported sensitivity/specificity in the 85-90% range [Olsson et al., Lancet Neurol, 2016; Blennow et al, Neurol Ther, 2017].

 

Blood

A recent meta-analysis does not support significant AD diagnostic value for plasma Ab, only plasma T-tau is strongly associated with AD [Olsson et al., Lancet Neurol, 2016]. Considerable efforts are invested in the development of AD blood tests [O’Bryant et al., Alzheimers Dement, 2017] and the novel analytical techniques may lead to screening test for AD [Ovod et al., Alzheimers Dement, 2017].

 

Ab-PET

Cerebral imaging with Ab-PET is the only method available to visualize the amyloid plaques during life. When compared with the gold standard post-mortem histopathology, the sensitivity/specificity is in the range 85-100% [Sabri et al., Alzheimers Dement, 2015; Ikonomovic et al., Acta Neuropath Comm, 2016; Morris et al., Eur J Nucl Med Mol Imaging, 2016].

 

Stratification potential

Optina

Optina’s current focus is the classification of the retinal images based on image features correlating with the cerebral PET amyloid status (positive/negative). Eventually, as the set of training datasets becomes richer, more classes (e.g. vascular risk, retinal oximetry, cerebral tau, neurodegeneration, and patient responder to a drug) could be included in the machine learning approach. Once the classifier is trained, the image analysis cost is not significantly affected by the number of biomarkers or classes considered by the algorithm.

 

CSF

In addition to the core AD biomarkers (Ab42, T-tau and P-tau) that reflect key aspects of AD pathophysiology, other potential CSF biomarkers are investigated. Of particular interest is neurofilament light (NFL) that could serve as a biomarker of neurodegeneration [Olsson et al., Lancet Neurol, 2016; Blennow et al, Neurol Ther, 2017]. However, each new compound to test will increase cost and complexity of the analytical method.

Blood

T-tau in plasma was found to be significantly different in AD than control [Olsson et al., Lancet Neurol, 2016]. Other potential blood-based biomarkers are under investigation at the early development level, but are still far from clinical use [O’Bryant et al., Alzheimers Dement, 2017]. Each new compound to test will increase cost and complexity of the analytical method.

 

Ab-PET

In addition to Ab-PET, FDG-PET (to evaluate glucose metabolism in the brain) and tau-PET (to evaluate the presence and geographic distribution of cerebral tau deposits, a hallmark of AD) have shown potential clinical significance in the diagnosis of AD [Marcus et al., Clin. Nucl. Med., 2014; Ossenkoppele et al., Brain, 2016]. However, each additional PET biomarker requires a tracer and a scan, meaning that the total cost becomes prohibitive.