Currently implemented projects to be realised jointly with private investment funds.

Project description: “Development of an algorithm and creation of device prototypes for eye pupil analysis.”

Ultimately, a company based in Zurich will be established to realise this project. As of 05.03.2026, there is still an opportunity for investment funds or private investors to acquire a 38% stake in the newly formed entity. Interested parties or institutions are kindly requested to contact us via email.

The developed solutions will be utilised as a first step in detecting the presence of drugs in the body, as well as in the early diagnostics of Alzheimer’s and Parkinson’s diseases.

Project value: €4.8 million

1. PROJECT OBJECTIVE

The primary objective of the project is to develop statistical models and algorithms for the analysis of eyeball movement, pupil behaviour, and its reaction to variable lighting. As part of the project, device prototypes utilising the developed solution will be created, alongside a mobile application serving as a computing platform for one of them. The possibility of utilising cameras built into commercially available mobile devices (phones/tablets) as an alternative data source for the developed algorithm will also be investigated.

The realisation of the project will result in three solutions:

A standalone device for professional applications:

ensures the highest measurement accuracy
the measurement algorithm is executed directly within the device
features an interface allowing for control and the reading of results

2. A device collaborating with a mobile application:

algorithm calculations are performed on the mobile device
the application acts as the device’s interface

3. A standalone mobile application:

utilises the camera and light source built into phones/tablets for measurements
algorithm calculations are performed on the mobile device
this solution may potentially be characterised by the lowest precision
broadest applicability

The device prototype created in laboratory conditions, EDILA (Eye Dynamics based Intoxication Level Analyser), will serve for laboratory testing, resulting in the collection of data necessary for refining and modifying the developed algorithms. During this testing phase, the influence of toxic substances on the dynamics of autonomic changes in eyeball position, tracking error parameters, parameters of autonomic changes in pupil size, and parameters of stimulated changes in pupil diameter will be analysed. Following the determination of model parameters and the classification of clinical trial results regarding the impact of selected toxic substances on eye dynamics, a mobile prototype of the MEDILA (Mobile Eye Dynamics based Intoxication Level Analyser) device will be created, which will subsequently undergo further clinical trials. The final stage of work will involve refining the prototypes of the aforementioned devices and developing a mobile application that will operate independently and serve as the interface for the intermediary device.

2. SCOPE OF RESEARCH WORK

TASK 1 Determination of methods for identifying dynamic eye parameters using eye trackers.

Duration M1-M4

The main phenomena based on which the impact of toxic substances on eye dynamics will be investigated are the dynamic properties of the eyeball and the dynamic properties of the iris. These properties will be investigated using eye trackers in stimulation scenarios defined based on hypotheses regarding the potential impact of toxic substances. Based on the images obtained from the experiments, dynamic parameters of the eyeball and iris, which are of interest for further analysis, will be determined. Resolving this task requires the creation of a method for identifying these parameters, which will depend on the tracking devices utilised.

Selection of eye tracking devices
Preliminary definition of eye stimulation scenarios
Determination of the eyeball position on the image originating from the tracking device
Determination of the iris parameters on the image originating from the tracking device

TASK 2. Modelling eye dynamics for the purpose of investigating the impact of toxic substances

Duration M5-M8

2.1. Development of a model of autonomic fluctuations in eyeball position for the purpose of investigating the impact of toxic substances.

Eyeball position coordinate waveforms (e.g., rectangular or angular coordinates relative to the central point of the pupil for the left and right eye in a steady state), calculated based on the methods developed in Task 1.1, which will be the subject of clinical trials (Task 5.1), will be utilised to create the model. The graph of each such waveform is a fluctuation curve on the plane of eye positions, which can be treated as a realisation of a two-dimensional stochastic process on a plane. The aforementioned stochastic process can be characterised by the eye dynamics parameter vector ϑ1 (which may include, e.g., means, correlation functions, non-linear parameters, etc.). The result of the research will be an estimator of the dynamics parameter vector ϑ1. These parameters will subsequently be investigated for sensitivity to toxic substances and utilised in the toxic substance impact model in Task 5.

2.2. Development of an eyeball tracking model for the purpose of investigating the impact of toxic substances.

Based on the sequence of images obtained as a result of the reaction to a light stimulus, the trajectory of eye positions will be determined, calculated based on the methods developed in Task 1.1. This trajectory will allow for the determination of the tracking error over time. This error is the effect of a random transformation of the “previous” positions of the stimulating point to the “current” eye position. The above transformation can be defined as a certain dynamic dependence of the error on “previous” errors and “previous” positions of the stimulating point. The development of the model will consist of estimating the statistical parameters of this dependence. The result of the research will be a model estimating the parameters of this dependence based on measurements obtained from the experiments in Task 5.2. These parameters will subsequently be investigated for sensitivity to toxic substances and utilised in the toxic substance impact model in Task 5.

2.3. Development of a model of autonomic fluctuation changes in pupil parameters for the purpose of investigating the impact of toxic substances.

Fluctuations in iris parameters (e.g., equivalent iris diameter), calculated based on the methods developed in Task 1.2, will be utilised to create the aforementioned model. The fluctuation curves of the iris parameters can generally be treated as realisations of a multi-dimensional stochastic process. This process can be characterised by the parameter vector ϑ3 (which may include, e.g., means, correlation functions, non-linear parameters, etc.). The result of the research will be the creation of an estimator of this vector, characterising the investigated fluctuations. This estimator will be investigated for sensitivity to toxic substances and utilised in the toxic substance impact model in Task 5.

The result of the research will be an estimator of the pupil dynamics parameter vector. These parameters will subsequently be investigated for sensitivity to toxic substances and utilised in the toxic substance impact model in Task 5.

2.4. Creation of a model of stimulated changes in pupil parameters for the purpose of investigating the impact of toxic substances.

Based on the sequence of images obtained as a result of the reaction to various light stimuli within the stimulation scenarios, curves of the realisation of the stochastic process, as in Task 2.3, will be obtained, albeit with an additional factor in the form of a dynamic stimulus. For each investigated subject, these curves illustrate, e.g., the stimulus intensity and the equivalent iris diameter over time, enabling the creation of dynamic models of selected dependencies, e.g., the dynamic dependence of the equivalent diameter on “previous” diameter values and “previous” lighting levels, characterised by a certain parameter vector. The result of the research will be a model estimating this parameter vector based on experimental data. These parameters will be investigated for sensitivity to toxic substances and utilised in the toxic substance impact model in Task 5.

2.5. Development of methods for estimating the impact of the level and type of intoxication on model parameters.

The parameter vectors determined within Tasks 2.1-2.4 form the resulting parameter vector of the model being developed. For the resulting parameter vector, a method of classification and/or estimation of the intoxication level will be developed for two concepts of model utilisation: a) regarding the level of toxic substances for individual subjects and the assessment of the possibility of estimating the intoxication level; b) regarding the level of toxic substances for group models (e.g., for all subjects, for different genders, people of different ages, etc.) and the assessment of the possibility of estimating the intoxication level. Both methods of application require different methods of statistical analysis of the results.

TASK 3. Clinical trial scenarios and construction of an IT platform for collecting research results

Duration M9-M12

3.1. Scenario for investigating autonomic fluctuations in eyeball position

The investigation of autonomic fluctuations aims to characterise spontaneous (random, without stimulation) changes in eye position. The need to investigate them is associated with research hypothesis H1: toxic substances impact the dynamics of autonomic changes in eyeball position. The investigation of autonomic fluctuations in the position of both eyeballs will consist of imaging utilising the methods developed in Task 2.1. As part of preliminary experiments, the desired observation time will be determined. The result of the research will be a scenario for the experimental investigation of autonomic eyeball fluctuations.

3.2. Scenario for investigating eyeball tracking

Tracking models aim to determine the congruence between the position of the tracked object (light point) and the eye position, with or without the effect of toxic substances. The need to investigate them is associated with the following research hypothesis: H2: toxic substances impact tracking error parameters. The investigation of tracking models will utilise the models developed in Task 2.2. As part of preliminary experiments, the type of simulation will also be determined, e.g., circular motion of the tracked point with gradually increasing angular velocity, or Brownian-type random motion. The outcome of the task will be a scenario for the experimental investigation of the tracking process.

3.3. Scenario for investigating autonomic fluctuations in pupil size

The investigation of autonomic pupil fluctuations aims to examine spontaneous (random, without stimulation) changes in pupil size. The need to investigate them is associated with the following research hypothesis: H3: toxic substances impact the parameters of autonomic changes in pupil size. The investigation of autonomic changes in pupil size will consist of imaging the eye over time and applying the identification methods obtained as a result of Task 2.3. The result of the task will be the determination of an experimental research scenario enabling the testing of hypothesis H3.

3.4. Scenario for investigating stimulated changes in pupil size

The investigation of changes in the pupil image aims to determine the relationship between the dynamics of changes in pupil parameters (e.g., equivalent diameter) during light stimulation in accordance with various scenarios, e.g., for a rectangular light pulse, a square wave, or Brownian-type random changes. The need for these investigations is associated with the following research hypothesis: H4: toxic substances impact the parameters of stimulated changes in pupil diameter. The research will consist of imaging the eye during light stimulation in accordance with various scenarios, with or without the effect of a toxic substance, and applying the methods determined within Task 2.4. This will allow for the determination of a model transforming the stimulating function into pupil parameters (e.g., equivalent diameter). The result of the task will be the determination of an experimental research scenario enabling the testing of hypothesis H4.

3.5. Creation of an IT platform for collecting research results

As a result of the task, software will be created serving to collect data from the EDILA analyser and allowing for their correlation with data obtained via interviews and other laboratory tests (e.g., blood tests) aimed at determining the type and level of the toxic substance in the body. The collected data will allow for the elaboration of the clinical trial results in Task 7.

TASK 4. Clinical trials of the impact of toxic substances using the EDILA methodology

Duration: M5-M16

4.1. Investigation of spontaneous fluctuations in eyeball position

The investigation of autonomic changes in the position of both eyeballs will initially be conducted in accordance with the assumptions defined in Task 1.2, and subsequently in accordance with the scenario created in Task 3.1. Measurements will be supplemented, where possible, with the result of a laboratory test of the toxic substance level in the blood. Measurements will be performed multiple times for each subject for a duration specified in accordance with Task 3.1, and their result for each subject will be sequences of eye images, which can be processed in accordance with the methods defined in Tasks 2.1 and 3.1. The result of the research will be a research database of spontaneous fluctuations in eyeball position, indexed by the type and level of the toxic substance.

4.2. Investigation of eyeball tracking.

The investigation of eyeball tracking will initially be conducted in accordance with the assumptions defined in Task 1.2, and subsequently in accordance with the scenario created in Task 3.2, multiple times for each subject, and supplemented, where possible, with a laboratory test of the toxic substance level in the blood. The result of the measurements for each investigated subject will be sequences of eye images, which can be processed in accordance with the methods defined in Tasks 2.2 and 3.2. The result of the research will be a research database of stimulated changes in eyeball position, indexed by the type and level of the toxic substance.

4.3. Investigation of autonomic fluctuations in pupil size

The investigation of autonomic fluctuations in pupil size will initially be conducted in accordance with the assumptions defined in Task 1.2, and subsequently in accordance with the scenario created in Task 3.3. Measurements will be supplemented, where possible, with the result of a laboratory test of the toxic substance level in the blood. Measurements will be performed multiple times for each subject, and their result for each subject will be sequences of eye images, which can be processed in accordance with the methods defined in Tasks 2.3 and 3.3. The result of the research will be a research database of spontaneous fluctuations in eyeball position, indexed by the type and level of the toxic substance.

4.4. Investigation of stimulated changes in pupil size

The investigation of stimulated changes in pupil size will initially be conducted in accordance with the assumptions defined in Task 1.2, and subsequently in accordance with the scenario created in Task 3.4. The research will consist of imaging the eye during light stimulation, with or without the effect of a toxic substance. Measurements will be performed multiple times for each subject in accordance with the scenarios from Task 3.4, and supplemented, where possible, with a laboratory test of the toxic substance level in the blood. The result of the research will be a research database of stimulated changes in pupil parameters, indexed by the type and level of the toxic substance.

Ophthalmological examinations will be performed, including the assessment of ocular motility and the measurement of pupillary reaction parameters to stimulating stimuli, in accordance with the study model in subjects prior to a planned surgical procedure and immediately following the procedure during which neuromodulatory pharmacotherapy was administered.

Ophthalmological examinations will be performed, including the assessment of ocular motility and the measurement of pupillary reaction parameters to stimulating stimuli, in accordance with the study model in subjects before and after the administration of analgesic or sedative medications.

Ophthalmological examinations will be performed, including the assessment of ocular motility and the measurement of pupillary reaction parameters to stimulating stimuli, in accordance with the study model in subjects following the ingestion of narcotics or psychoactive substances, and repeated during the period of decline in the substance level within the body.

Ophthalmological examinations will be performed, including the assessment of ocular motility and the measurement of pupillary reaction parameters to stimulating stimuli, in accordance with the study model in subjects prior to the commencement of planned substitution therapy, and repeated during the therapy.

TASK 5. Proof of concept for modelling the impact of intoxication using the EDILA method

Duration M13-M20

5.1. Estimation of eye dynamics model parameters and classification of the level and type of intoxication

The results of the clinical experiments, obtained from the realisation of Task 4, will be processed using the methods obtained in Task 3 to acquire the resulting parameter vector ϑ, containing the characteristics of all sub-experiments of the model being developed. Based on the methodology developed in Task 3, an analysis of the sensitivity of the elements of the resulting vector ϑ to the type and level of toxic substances will be conducted. Consequently, a sub-vector ϑ⋆ will be selected, comprising parameters that enable the optimal detection of toxic substances, followed by the efficient classification and/or estimation of the intoxication level. Utilising the methodology developed in Task 3, methods for the classification and/or estimation of the intoxication level will be determined for two concepts of model utilisation: a) regarding the level of toxic substances for individual subjects and the assessment of the possibility of estimating the intoxication level; b) regarding the level of toxic substances for group models (for all subjects, for different genders, people of different ages) and the assessment of the possibility of estimating the intoxication level.

5.2. Construction of the EDILA device for the purpose of investigating the impact of toxic substances on eye dynamics

The results of the research conducted in Task 5.1 will allow for the verification of the possibility of investigating the intoxication level based on the observation of eye dynamics via EDILA. The EDILA tool will incorporate eyeball movement stimulators and lighting stimulators, image recorders, and an algorithmic component, designed within Tasks 2, 3 and 5. The image recorders will perform the appropriate measurements of recording the eye image during stimulation. Based on this recording, the trajectories of the eye position and iris parameters over time will be estimated, from which the parameters of the corresponding dynamic models will be determined, subsequently serving the classification of the level and type of intoxication. The capabilities of EDILA can be expanded to include the function of recognising the investigated subject based on the iris pattern. The outcome of Task 5.2 will be a prototype unit of EDILA, accompanied by a functional and technical description.

TASK 6. CONSTRUCTION OF MEDILA AND MEDILA Connect MOBILE ANALYSERS and creation of the MEDILA App

Duration M21-M30

6.1. Modification of algorithms and measurement sensors for application on mobile devices and SBC (Single Board Computer) platforms

The ultimate outcome will be the creation of MOBILE EYE DYNAMICS based INTOXICATION Level Analyser MEDILA devices, hereinafter referred to as drug screeners, possessing the properties of the EDILA device. In mobile devices, it will be essential to utilise a different type of measurement regime, different stimulators, and different recorders, and consequently, different algorithms. The result of the task will be the modification of EDILA and the creation of designs for the Mobile Eye Dynamics based Intoxication Level Analyser, and consequently, the execution of mobile device designs.

6.2. Appearance prototyping and usability testing using 3D printing

As a result of the task, utility and functional designs of the mobile devices will be developed. Hand-held apparatus is characterised by the necessity to introduce additional mechanisms ensuring the minimisation of the examiner’s hand tremors and the correct positioning of the device relative to the investigated subject’s eye. It will be necessary to investigate whether a preview of the image from the device’s camera will be sufficient for this purpose, or whether the utilisation of additional sensors (e.g., indicating the correct distance from the investigated subject’s eye) will be essential. The impact of ambient light will also be verified, and user interfaces will be developed to ensure the control of the device, guaranteeing minimal impact on tremors during the examination, as well as a clear presentation of the research results.

6.3. Construction and programming of MEDILA mobile devices

The designs developed in Tasks 7.1 and 7.2 will serve here to construct a prototype of a standalone MEDILA device based on an SBC (Single Board Computer) platform, possessing a set of stimulators and recorders enabling the execution of the examination developed in Task 6.2. The device will be equipped with an interface allowing for its control and the reading of results.

6.4. Creation of the MEDILA App mobile application

The task will result in a standalone MEDILA App application, utilising the algorithm modified in Task 7.1, enabling the utilisation of components built into mobile devices (phone, tablet) to conduct an intoxication examination. A graphic design and a UI/UX interface design will be executed based on the research results from Task 6.2. The application will also have an informative character, organising knowledge in the field of recognising signs of drug intoxication and a database of rehabilitation centres, and it will perform a marketing and advertising function.

6.5. Construction and programming of MEDILA Connect mobile devices and adaptation of the MEDILA App

The designs developed in Tasks 6.1 and 6.2 will serve to construct a prototype of the MEDILA Connect device, characterised (to minimise the final costs of the device) by a simplified examination scenario and the absence of a built-in control interface. This role will be fulfilled by a wirelessly connected mobile device (phone, tablet). As part of the task, the MEDILA App created in Task 7.4 will be expanded with a module for communication with the MEDILA Connect device, ensuring the possibility of its control and the reading of research results. It will be necessary to develop transmission protocols allowing for a real-time preview of the image from the camera of the MEDILA Connect device. This is essential for the correct positioning of the device in order to conduct the examination.

6.6. Development of test scenarios and testing of laboratory mobile devices

A scenario for testing the correct operation of MEDILA devices on laboratory data will be created, and the devices will be laboratory-tested.

6.7. Development of test scenarios and application testing

A scenario for testing the correct operation of the MEDILA App will be created. Based on it, tests will be conducted on various mobile devices.

TASK 7. MOBILE TRIALS: Mobile trials of the impact of toxic substances using the MEDILA “drug screener”

Duration: M29 – M34

Investigations of the toxic substance level utilising MEDILA mobile devices

The task will consist of testing the suitability of MEDILA for the mobile determination of the toxic substance level. The investigations will encompass the broadest possible range of toxic substances.

Statistical analysis of clinical trial results

Statistical analysis will allow for the verification of the practical suitability of MEDILA as a preliminary intoxication level analyser in schools, domestic settings, and typical police work environments (similar to a breathalyser).

Ophthalmological examinations will be performed, including the assessment of ocular motility and the measurement of pupillary reaction parameters to stimulating stimuli, in accordance with the study model in subjects before and after the administration of analgesic or sedative medications.

Ophthalmological examinations will be performed, including the assessment of ocular motility and the measurement of pupillary reaction parameters to stimulating stimuli, in accordance with the study model in subjects following the ingestion of narcotics or psychoactive substances, and repeated during the period of decline in the substance level within the body.

Ophthalmological examinations will be performed, including the assessment of ocular motility and the measurement of pupillary reaction parameters to stimulating stimuli, in accordance with the study model in subjects prior to the commencement of planned substitution therapy, and repeated during the therapy.

TASK 8. UTILISATION OF MEDILA ANALYSERS: Mobile trials of the impact of toxic substances using the MEDILA “drug screener”

Duration M32-M34

Scenarios for the utilisation of MEDILA analysers

Operating procedures for utilising MEDILA as a preliminary intoxication level analyser in schools, domestic settings, and typical police work environments will be developed. Operating manuals for such devices will be developed.

3. CURRENT STATE OF KNOWLEDGE REGARDING THE SUBJECT OF THE RESEARCH WORK

Changes in eye pupil size depend on neuroautoregulation and the impact of external stimulating factors. The human autonomic nervous system consists of two parts: the sympathetic and the parasympathetic. The action of the sympathetic system primarily serves to mobilise the body for action, whereas the parasympathetic system serves for rest and regeneration.

The difference in innervation is presented by the antagonistically acting muscles within the iris.

Pupil examination is a commonly utilised preliminary medical test assessing the presence of nervous system reactions to a light stimulus. A routine, subjective examination typically assesses the pupil diameter and the symmetry of the direct and consensual reaction. The construction of an automated pupillometer featuring an infrared camera currently enables objective and precise measurements of pupil size, alongside the recording of change dynamics.

Pupillometry is a sensitive method for examining the pupil and assessing the functioning of the autonomic nervous system. The current pupil size is the resultant of three mechanisms: the pupillary light reflex and changes in the intensity of light stimulating retinal photoreceptors; the reaction to the approach of a fixation point as the observed object nears the eye; and the psychosensory reaction dependent on the current psychological state.

Beyond this complex controlling system, there additionally exists a constant, recordable oscillatory pupillary tremor.

Identified factors impacting pupillary reaction parameters include: the investigated subject’s age, gender, current emotional state, and degree of fatigue or somnolence. Among the factors still being analysed is the comparison of the impact of white versus monochromatic light stimuli.

Medications and narcotics, depending on their chemical composition and dosage, impact the width and reactivity of the pupil to light via their influence on nervous system neurotransmitters. The action of narcotics, through the same mechanism, can slow down and disrupt convergence and induce other eyeball movements, i.e., movements shifting the gaze and movements maintaining the gaze.

Clinical trials demonstrate that following the ingestion of 3,4-methylenedioxymethamphetamine or tetrahydrocannabinol, central inhibition of the parasympathetic system occurs, leading to a delay, as well as a reduction in the amplitude and velocity, of the pupillary reaction to light.

The emergent predominance of the sympathetic system, in connection with an elevated level of noradrenaline and serotonin, leads to mydriasis and a reduction of the recovery phase in reaction to a stimulus, which may indicate a state of intoxication.

The results of research conducted in various centres indicate that pupillometric analysis, in an incomparably shorter time than biochemical tests, could have practical application in identifying individuals who may be under the influence of chemical substances impacting central nervous system reactions.

There is also a growing body of evidence linking changes in the eye pupil with Alzheimer’s and Parkinson’s diseases.

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4. THE NEED FOR THE EXECUTION OF RESEARCH WORK AND PRODUCT DEMAND

According to the European Drug Report 2018 published by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), the overall availability of drugs in Europe is high and continues to rise. The market for illicit narcotic substances, so-called “designer drugs”, is developing particularly dynamically. Over 92 million adults in the EU (aged 15-64) have tried drugs in their lifetime, and approximately 1.3 million individuals entered treatment for drug use in 2016 (EU-28).

Due to the increasing availability of drugs, the prevalence of utilising various types of tests detecting psychoactive substances in the body in domestic settings is rising. Drug tests available on the Polish market, intended for execution in domestic settings, detect basic drugs and certain medications. Urine or saliva is most frequently utilised as the tested material within them. The disadvantage of commercially available tests is their reaction to solely a specific drug, the possibility of committing an error during the test’s execution, and the potential for falsifying results by, inter alia, adding available chemical substances to the urine sample that alter the urine pH to alkaline.

It should be borne in mind that increasingly novel combinations of chemical compounds are utilised in the production of psychoactive substances, the detection of which in domestic settings is frequently impossible. According to the aforementioned EMCDDA Report, synthetic cannabinoids are one of the four main types of new psychoactive substances (NPS). An important factor exacerbating their use is the very difficulty in detecting them in drug tests. A further disadvantage of the tests is their availability and price. The response to the market demand in the aforementioned scope will be a device and an application which, based on eye pupil behaviour and eyeball dynamics, will allow for verifying whether a given individual is under the influence of psychoactive substances, and may indicate the probable group of ingested substances.

While it is widely known that psychoactive substances impact eye pupil behaviour or the level of intraocular pressure, the scope and precise spectrum of this impact are not fully understood. In order to achieve the highest possible reliability of the test results that will be conducted using the device, it is necessary to carry out research work consisting of the observation and comparison of eyeball images, based on which a statistical algorithm will be developed. As a result of the project’s realisation, the problem associated with the availability of a reliable tool detecting the presence of psychoactive substances in the body will be resolved. It should be borne in mind that specific psychoactive substances can be detected in the human body (depending on the type of ingested substance) only for a defined period. In the case of, for example, LSD, the detection of which by commercially available tests is impossible, this is a period of merely a few hours. Thanks to the application that is the subject of this project, an immediate reaction in the form of conducting an examination will be possible. Commercially available tests are also unable to detect the presence of many NPS appearing on the market, such as synthetic cannabinoids. Due to the fact that the aforementioned compounds do not remain without impact on eye pupil behaviour, it is assumed that they will be capable of being detected using the application/device. Another problem in addiction diagnostics is the exceptionally high cost of specialist laboratory tests. Preceding a laboratory test with a brief examination performed using the device that is the subject of the project’s realisation may allow the laboratory test to be directed towards a given group of drugs and minimise the examination costs.

5. DESCRIPTION OF EXISTING SOLUTIONS AND THEIR FLAWS, WHICH WE WILL BE CAPABLE OF ELIMINATING

Currently, neither on the Polish, European, nor American market does there exist a device or application that, based on eye pupil behaviour and eyeball movement, detects the presence of psychoactive substances in the body, or detects Alzheimer’s or Parkinson’s disease.

The most prevalent tools for conducting a drug examination in non-laboratory settings are tests available for purchase in pharmacies, in which urine or saliva constitutes the investigated material. Less prevalent are tests investigating the presence of psychoactive substances in sweat or hair. The disadvantage of all the aforementioned tests is the relative ease of falsifying their results.

Various practices are employed: urine dilution, the addition of foreign substances, or sample substitution. The most popular of these is dilution through the addition of water or other fluids to the urine sample. Dilution may also be the result of an increased fluid intake or the ingestion of diuretics a few hours prior to the planned examination. Occasionally, this method of falsifying the sample can be masked by preparations available on the internet containing, inter alia, B-group vitamins and creatine – a creatinine precursor, which are intended to imitate the correct colour and normalise the content of physiological urine components. Another method of falsifying the determination result is the addition to the urine sample of foreign substances destroying the structure of the investigated compounds. For this purpose, nitrates, which oxidise tetrahydrocannabinols and opiates, are frequently utilised. The aforementioned practices can lead to a decrease in the concentrations of the investigated substances below the test’s sensitivity, particularly when the initial analyte concentration was low.

The second group of commercially available tests comprises tests detecting the presence of drugs in saliva. One of their disadvantages is also the possibility of falsifying the result. On the Polish market, products from companies such as Ultraklean are available and commonly utilised; these cleanse saliva of psychoactive substances, making the detection of drugs via saliva tests frequently impossible. Furthermore, as emerges from a Report conducted by the Department of Forensic Medicine, Faculty of Medicine at the University of Warmia and Mazury in 2018, regarding studies assessing the suitability of saliva testers, including those conducted within the DRUID and ROSITA projects, in which over a dozen testers were checked in total, their application is severely limited due to unsatisfactory results in terms of sensitivity, specificity, and accuracy. In the work by Nichterwitz Scherer et al., data from several dozen studies concerning over a dozen saliva testers were compared. When assessing the sensitivity, specificity, and accuracy of the test, substances such as amphetamine, cannabinoids, cocaine, opiates, and benzodiazepines were taken into consideration. The study indicated a significant dispersion of the obtained results, which substantially limits the possibility of utilising saliva testers for the routine inspection of drivers. In considerations regarding the suitability of saliva testers, one more issue cannot be overlooked. All the cited studies refer to saliva testers detecting so-called classic drugs, namely, inter alia, THC, amphetamine, cocaine, opiates, or benzodiazepines. Currently, however, we are dealing with a new phenomenon, namely, unprecedented variability of substances on the so-called psychoactive substance scene. New agents emerge so rapidly – in 2016, on average, approximately one per week – that even acquiring materials for the laboratory is problematic. It is therefore easy to imagine that the time required to create, e.g., an immunochemical test detecting specific substances and introduce it into use will be so long that these substances will have already been replaced by a subsequent generation, and the testers will become useless. Thus, while the utilisation of testers for the presence of popular agents, such as marijuana, amphetamine, opiates, cocaine, or benzodiazepines, during roadside checks is justified, the introduction of testers detecting new psychoactive substances is scarcely realistic. The authors of the analysis associate hope in this regard with technological progress and the opportunity to develop devices or software for the assessment of pupils and ocular motility, which may allow for the objective screening of road traffic participants. Eyeball and pupil behaviour, as well as their reaction to light, is an involuntary reflex that cannot be influenced; hence, falsifying the results through the ingestion of any of the aforementioned detoxification agents will not be possible.

6. DESCRIPTION OF THE TARGET MARKET FOR THE PROJECT.

We target our product at public institutions.

According to the EMCDDA report, disturbing signs of an increased level of drug production in Europe, closer to consumer markets, are visible. Technological progress facilitates this development, and also connects European drug producers and consumers on global markets via the surface web and the dark web. The growing availability of psychoactive substances and the difficulties in detecting them lead to an increase in the number of individuals deciding to ingest them. Poland ranks among the leading countries in terms of drug consumption.

According to data from the National Police Headquarters — the number of road traffic accidents in which the perpetrator was under the influence of narcotic agents, primarily marijuana and amphetamine, but also cocaine, ecstasy, or NPS, is growing. This stems from both the fact of downplaying the impact of drugs on the driver’s psychomotor performance and the fact that drug use is less visible to the surroundings and may be more difficult to detect, e.g., by the police.

The device that will be created as a result of the project’s realisation will enable the execution of routine drug examinations of drivers, which may translate into a reduction in the number of accidents caused by drivers under the influence of psychoactive substances, and, above all, will impact greater social awareness in this regard. It should be noted that the disposable saliva drug tests utilised by the police are expensive, hence they are not utilised for routine checks. Also significant is the fact that on the Polish market, products from companies such as Ultraklean are available and commonly utilised; these cleanse saliva of psychoactive substances, making the detection of drugs via tests conducted by the police impossible, and therefore they have not been introduced into widespread use. According to current procedures, checks for the presence of drugs in the body are not conducted even in the event of causing accidents. Individuals are directed for drug tests only in exceptional situations, e.g., in the case where the perpetrator was previously recorded for offences related to violating the anti-drug act, for whom there is a higher probability that they are under the influence of drugs.

The standalone device will be capable of being utilised not only by the police but also by other public services: municipal police, metro, railway, and airport security guards, etc. We also target the device at public institutions such as schools, higher education institutions, and addiction and drug abuse treatment clinics.

Furthermore, as a result of the project’s realisation, an application will also be created that will enable the execution of an examination using a mobile phone. Via the application, it will be possible to rapidly check whether children or relatives are under the influence of psychoactive substances. The application will be publicly available and free of charge in both the Google Play store and the App Store; solely a mobile phone or tablet will be required for its use. Very frequently, initial suspicions regarding the use of psychoactive substances by relatives are downplayed and do not constitute a sufficient basis to order one of the commercially available drug tests. Ease of access to the application may positively impact the reaction time and the detection of drug use at the earliest possible stage. The application also enables the monitoring of abstinence in individuals who have had contact with drugs.

7. IDENTIFIED COMPETITION

A project with a partially similar application appears to be the drug test e-service offered via the drugtest24.pl website. The aforementioned project was realised in 2014 and is not being developed in any way. By design, it is an application dedicated solely to mobile phones with the Android operating system. Currently, it is impossible to download the aforementioned application. To the Applicant’s knowledge, drugtest24 relied on a simple algorithm and known parameters of pupil size, its assumed reaction to light, and eyeball colour. The algorithm was not developed in the course of scientific research work, as is planned within this project.

Research work consisting of the analysis and construction of models of eye dynamics and iris radius dynamics, taking into consideration the impact of toxic substances for the purpose of their detection, alongside the development of methods for the statistical analysis of models based on experimental data and appropriate algorithms, may allow for achieving the assumed objective, which is the creation of a device and an application that will be capable of being utilised as a first step towards the diagnostics of psychoactive substance ingestion.

The product that is the subject of the realisation of this project will be publicly available in the Google store (phones with the Android operating system) and App Store (Apple phones).

Work on similar solutions conducted in the United States in the years 1995-2010 was not based on such advanced algorithms and research as are planned for realisation within this project, particularly taking into consideration the technological progress that has occurred over the past two decades. Nevertheless, based on the results of clinical trials conducted at that time, an enormous potential in this regard can already be stated.

The above confirms the conclusion from the report prepared in 2018 by the Department of Forensic Medicine, Faculty of Medicine at the University of Warmia and Mazury. According to the authors, who subjected methods of preliminary non-laboratory assessment of the inability to drive vehicles caused by psychoactive substances to analysis, technological progress and the cited mentions regarding the application of drug detection devices based on eye pupil analysis in a stationary form provide hope that in the near future, attempts will be made to implement an objective eye assessment as a method of preliminary assessment of drivers under the influence of psychoactive substances.

Currently, scientists from Canada are conducting work on a similar solution (Opthalight), which is also intended to serve the early detection of pupillary defects; however, no scientific data has yet been published, nor is there any knowledge regarding the research approach. From publicly available information, it can be deduced that the company creating the aforementioned device proceeded from the assumption that the device would replace blood results and constitute definitive evidence of drug ingestion, e.g., in court proceedings, which in our opinion may be difficult, particularly when an accurate estimation of the level of psychoactive substances in the body is necessary in order for forensic toxicologists to estimate their potential impact on human consciousness.