Soterius

Currently, the world is focused on individual diagnostic tests for viruses that rarely are linked to immediate broader societal protection. The Soterius Scout Biosensonsor is a passive (no battery) device, comprised of a non-biological nanotechnology sensor that doesn't degrade. The sensor can communicate with near-field communication devices such as phones and door access systems to warn of potential threats in real-time. The Scout biosensor can easily be scaled for a number of pathogenic threats beyond its current configuration for SARS-CoV-2. The device works with the technology available in resource-poor settings and can be refreshed by green chemistry if triggered. When linked with location data the device will eventually be able to use AI to predict hot spots as they emerge providing information to communities empowering them to tackle pathogenic threats on their own terms. Housing, electronics, and nanotechnology can all be scaled for mass manufacturing.   

The current SARS-CoV-2 pandemic has resulted in incalculable tonnes of single-use PPE and other medical equipment waste due to avoidance of cross-contamination. Providing fair access to the Soterius Scout biosensor to a broad range of communities improves surveillance and accurate detection of existing and novel outbreaks, as well as the general presence of airborne pathogens. Improved surveillance results in faster responses to outbreaks, leading to earlier enactment of preventative measures, and a limited spread of disease, resulting in less PPE and treatment equipment being required, and thus, less wastage. The sensor can also give communities the information on spread of viruses directly enabling ownership outbreak management.

Incorporating fair access to the sensor additionally reflects a long-term vision of Soterius. Infectious diseases and pandemics do not respect national borders. They are a global problem requiring a global response. Soterius’ current target market includes Australia, Singapore, the UK, and the USA. However, Soterius aims to demonstrate that it is equally, if not more important to ensure that communities across Oceania are given priority fair access to the sensor. Currently, approximately 50% of deaths in under 45s in resource-poor settings are caused by viruses. This is the problem we want to address. 

The Soterius Scout biomimetic sensor can accurately detect SARS-CoV-2 in the air into the picomolar range. This is achieved via a portable fob that is passively powered (no battery) and NFC compatible with smartphones and readers. The fob design integrates with masks, breathalyzers, key chains, and wall mounts. The industrial design includes grooves that allow it to neatly clip into many holder scenarios. The Soterius biomimetic sensor utilizes molecular imprinted nanotechnology to recognize SARS-CoV-2 spike protein. The sensor is both specific and accurate because of the combination of the nanotechnology and the novel sensor technology that its bound to, together forming a microcontact electronic device. Importantly it is scalable to other infectious diseases such as influenza. The technology doesn't degrade, has low manufacturing costs and integrates well with solutions already in place in resource-poor settings. The sensor can be used flexibly as either a warning of threat, diagnostic or in geolocating of potential exposure sites, which could be used in supply chain management. The sensor can be refreshed with green chemistry solutions and is, therefore, a sustainable choice in many settings.   

The solution is targeted for initial deployment in vulnerable regions, exemplified by most Oceanic countries. These countries have a high-risk incapacity to cope and are relatively susceptible, compared to their low-risk “developed” neighbors Australia and New Zealand. However, this approach often takes away from the rich complexity of cultural considerations, beliefs, and languages found across the Pacific. It also disregards the political decisions made by many leaders of resource-poor countries facing extreme external risk from climate change, healthcare system structure, international politics, and international decisions. Thus, when looking specifically at vulnerability to infectious disease, Soterius has attempted to reflect the opinions, needs, and perspectives of SIDS (see definition below) leaders towards their own vulnerabilities by drawing from key points given in statements by the AOSIS (see definition below) in 2020. These vulnerabilities include the following: weak healthcare systems, lacking medical equipment including ventilators, lacking essential medical supplies, including the capacity to test for SARS-CoV-2 and PPE, obstacles in accessing supply chain alongside a shortage of foreign exchange and high procurement costs, narrow resource base, remoteness, scarcity of natural resources, dependence on food exports, economic and financial risk exposure and high environmental vulnerabilities.

Soterius currently is partnered with Monash University Advanced Science degree: Global Challenges, employing three final year undergraduate interns to evaluate how we will deploy our solution to the settings discussed above. One student is interviewing key stakeholders across the sector including the people we wish to serve to identify the most appropriate response. Another intern is working on making sure variants emerging in these regions can be detected by our sensor. The final student is working on, low-cost green chemistry solutions for rejuvenating the sensor an important step in sustainability in all settings. Soterius works directly with a range of staff at Australia's only medical research organization with NGO status The Burnet Institute. The values of Soterius are a close reflection of the Burnet it allows us to work collaboratively on our aim to give fair access to our technology. The Burnet Institute already works in these settings giving us an established network and knowledge base to work from. It is worth noting in developed nations the technology will be sold for profit. Soterius believes it's not an either-or situation and each scenario benefits the other, we view our company as a for-profit but socially conscious business. 

Definitions:

Small Developing Island States (SIDS) of the Pacific Ocean region: refers to the 13 Pacific Island States listed by the UN, who share a unique set of social, economic and environmental vulnerabilities. This includes: Fiji, Marshall Islands, Nauru, Papua New Guinea, Solomon Islands, Tonga, Vanuatu, Kiribati, the Federated States of Micronesia, Palau, Samoa, Timor-Leste, Tuvalu

Alliance of Small Island States (AOSIS): A coalition of 44 small island and low-lying coastal developing states. In the Pacific Ocean region, this includes: Cook Islands, Fiji, Kiribati, Marshall Islands, the Federated States of Micronesia, Nauru, Niue, Palau, Papua New Guinea, Samoa, Solomon Islands, Timor-Leste, Tonga, Tuvalu, Vanuatu

Oceania: refers to the 14 countries and 9 dependencies within the geopolitical continent of Oceania. This includes: Australia, Papua New Guinea, New Zealand, Fiji, Solomon Islands, the Federated States of Micronesia, Vanuatu, Samoa, Kiribati, Tonga, Marshall Islands, Palau, Tuvalu, Nauru, New Caledonia, French Polynesia, Guam, Northern Mariana Islands, American Samoa, Cook Islands, Wallis & Futuna, Niue, Tokelau

Soterius provides a device that is able to detect the live virus in environments or pre-symptomatic patients, critical in early detection in any healthcare setting. It gives the clinicians a chance to equip themselves at the earliest possible opportunity to the viral threat. Connection of Scout biosensor with phone or reader will indicate the threat level and provide actionable suggestions. The long-term strategy is to build in geolocation and learning systems to provide broader safety information to the user. It is likely social media listening will be combined with the sensor to indicate hot spots as they emerge in real-time. 

Soterius Pty Ltd. is a start-up company that has raised pre-seed round. The company has a working physical prototype currently being tested with SARS-CoV-2 varients after successful RBD and Trimeric protein trials. We have a first iteration of the casing designed under ISO:13485. We have agreed to run a pilot study of 100 people with hotel quarantine because it allows for gold-standard validation in a controlled environment to run with Australia's Medical Device Partnering Scheme. 

Soterius's solution is innovative in its ability to be recycled in a largely disposable diagnostics market. Its nanotechnology does not degrade over time and can be cleaned with safe salt solutions. In the market, this changes the prospects for both low and middle-income countries that are able to reuse technology saving them money. In the higher income setting, we also see clinicians demanding higher environmental standards for diagnostics while maintaining high reproducibility and reliability of results. If one company begins to change what is possible this can positively influence other diagnostic manufacturers not just in the infectious disease space but across the whole industry. The sensor also digitized its results allowing rapid dissemination of information in regards to positive detection. A problem for all countries has been the slow detection and contract tracing of people with SARS-CoV-2 virus by PCR and even early lateral flow tests. This will allow the use of AI mapping of hot spots in any setting giving epidemiologists better more up-to-date information for their predictive monitoring of situations as they emerge. Longer term our technology will use machine learning to detect and predict variant spread we see a natural wobble of variants in nanotechnology which will enable us to predict these variants as they emerge.  

Currently, our solution serves no people, Soterius in the next quarter plans a 100 person trial. This initial test is part of the Medical Device Partnership scheme Soterius is part of. The schemes aim to independently validate our technology and expand our network. 

Within a year Soterius aims to serve 10,000 people with initial manufacturing runs. These customers will be reached through early onshore manufacturing while QMS is built up and sensors go through field testing. 

Within five years we aim to reach five million consumers. This is in line with serries A investment and reaching sales growth to match manufacturing. 

• Soterius will measure its output of sensors and importantly the ratio of sensors for developed and resource-poor settings. 
• Soterius will measure its ratio of private equity to charitable and grant funding. It is important that money raised from investors delivers sustainable profit so that sensors can be manufactured at the lowest cost for low to middle-income countries. 
• Soterius will measure uptake of technology in the pacific islands and feedback on its integration into daily life by means of continuous market research with customer feedback. 

• 2 FTE CEO and CTO
• 3 Monash University advanced science degree Global Challenges interns FT
• 3 Advisors: Governance, Virologist, Clinical AI
• Part-Time: Legal & CFO
• Contract: Regulatory, Industrial Design, IP

Soterius was founded by Alasdair (scientist) and Chih (business) who were passionate about delivering a solution to what we perceived in 2018 to be a large threat to a global pandemic. Neither of us has a background in virology instead we have enough capability and experience as a scientist and a business professional not to be seduced by our expertise and to constantly rethink our assumptions. We brought A/Prof. Anderson deputy director of the Burnet Institute to challenge us on everything to do with viruses. Michelle Gallaher is our Clinical Ai expert being CEO of Opyl. Dr. Elane Zelcer is deputy chair of the Bio Melbourne network and our key mentor in her key role in governance. Soterius has three undergraduate interns April, Meytar, and Marta from the Monash advanced science degree global challenges akin to extra MBA training on top of their science studies. The students act as a youthful sounding board keen to put their science skills to the test. Their key goals are the fair and sustainable deployment of the Soterius sensor. They have been trained in green scientific practices and social responsibility key skills for Soterius's vision. Currently, the Soterius team is comprised of five different nationalities with a large range of skill sets. In the future, as we move into Papanu Guinea and other low-income settings, we will welcome new talent from these countries onto our team with our charitable board likely to reflect in-country leadership. 

Culture: Soterius set its organizational culture earlier this year with all team members. Soterius has been trained in the Medical Technology accelerator to always look for unconscious bias in all our appointments. We are looking for passionate people who value process above optics. Female representation on our board is a priority in that we want the board to be a balance to be reflective of society and therefore our customers.  

Training: Soterius is always looking for training opportunities for its founders so they make fair decisions on hiring not driven by unconscious bias. Soterius will also look to train its team so they are inclusive. 

Governance: Our advisors are all champions of change and inclusion.  Dr Elane Zelcer is our chief advisor on governance and is our key appointment to ensuring diversity been deputy chair of Bio Melbourne network she is a strong advocate for inclusion at every level but always merit-based. Michelle Gallaher is CEO of Opyl an ASX listed AI clinical trials firm, is well known in the Australian ecosystem for diversity and inclusion, Michelle is a particularly strong advocate of women in STEM. Prof. David Anderson is deputy director of the Burnet Institute and has always been inclusive in his technology distribution of technology and appointment of his international team. 

Soterius is applying to solve for the three things that drive our business forward:

1. New knowledge, gained by critical assessment allowing us to think again about our ideas. We always want to learn from every experience. 

2. Network, the stronger our network is the more likely we will be able to affect change.

3. Capital, to keep the product development moving forward and gain momentum. 

Soterius doesn't know exactly what our resource-poor delivery will look like and we need help guiding us. Our for-profit business is guided by excellent mentors who are very good with the for-profit side. However, we all know we need to be both sustainable and equitable in our delivery. This is an opportunity to strengthen our roots into fair delivery of our technology to all. We believe the best medical technology should be available to all.

1. Soterius needs to expand beyond the confines of Australia and would like to learn more about American VC and styles that land well in the USA. 
2. We need help to evaluate our technology both in the USA and in resource-poor settings. We would like to recruit local trial professionals or train them with eventual exchanges between researchers between sites. 
3. We have an idea of how we might distribute and surveyed key stakeholders however we realize we need more input in this part of our business. 

• WHO Asia Pacific- To better understand the needs of technology in resource-poor setting and global efforts to prevent pandemics
• Medical Sans Frontieres- How our technology could fit within a disaster setting
• MIT Infectious disease staff such as Prof. J.G. Fox- to build independent validation of technology in USA and drive important changes as we develop
• Eric Schmidt- How can we link our technology to global monitoring of hot spots as they emerge

The Soterius solution does not distinguish between sexes but gives individuals the personal information they may need to improve their health outcomes.

The Soterius sensor is a purely digital output of viral detection giving us a great advantage over our competitors to combine with AI. The Soterius solution will use AI to determine disease hot spots as they emerge by using data the sensors collect to triangulate and weight positive detection. The sensor can be programmed using machine learning to pick up the natural wobble of variants in the sensor as they are detected. Combined with global positioning in phones and static readers a picture emerges of variants across continents. We are early in the development of AI but by combining physical detection with social listening we will gain greater confidence in our ability to detect virus hot spots as they emerge. 

The Soterius solution is designed to detect last-mile SARS-CoV-2 and eventually influenza. The solution is a digital detection of the virus using robust nanotechnology. This means the sensors integrate well with readily available technology on the ground such as mobile phones. The devices can be cleaned with low-cost green chemistry again readily available globally. Our for-profit vehicle provides an opportunity to manufacture at scale and feedback the benefits of low unit costs for the resource-poor setting. The technology does not degrade in hot humid environments and can be stored for decades without degradation. The solution importantly gives the user ultimate control of what to do with the data. It can be used as a diagnostic or warning system for the user and will eventually link to predictive AI technology to enhance utility further.