TBscan

Tuberculosis,TB, is an infectious respiratory disease that kills over one million people every year. TB is difficult to detect and there is no rapid test. This is why we are developing TBscan the first ever solution that can instantly detect TB dispersed in air.

TBscan used in crowded areas, such as hospitals, will instantly detect the presence of someone with active TB generating infectious aerosol droplets with TB.

After scaling in hospitals in Greece, with the help of a network of Pulmonary Doctors who are supporting us, we will look to expand to high-TB burden nations, e.g., India. We believe that TBscan can will help UN realize its “EndTB” goal of reducing TB deaths 90% by 2030.

Tuberculosis, TB, is a major killer worldwide with more than 1.4m deaths every year (see WHO Global Tuberculosis Report 2020). A key problem in controlling TB is the detection of the TB mycobacterium in patients which is a lengthy and laborious task. Early and rapid detection methods could greatly facilitate the management of TB but are completely lacking.

TB detection is a key bottleneck in attempts to reduce the annual global new cases of TB which the UN is seeking to decrease by 2030 (WHO World TB Announcement 2021). Indeed, a person with active TB can easily infect more than ten people before detected (link).

Thus it is no surprise that every year we have 10 million new cases globally of which more than 500k are of the drug resistant form. 

The impact opportunity for this problem is immense. (see Fox et al. 2013). An early and rapid detection system would identify infected subjects who could then be isolated before they transmit TB to others. These subjects would benefit themselves as more effective treatment is possible earlier in the progression of the disease. And the others would benefit by avoiding infection.

The TBscan solution features a novel optical system that detects the TB mycobacterium based on its property of autofluorescence. The system consists of a flow-device where droplets, obtained from air, are irradiated by a laser pulse in a narrow channel. The mycobacteria in the droplets emit a faint fluorescence signal which is amplified and detected. The TBscan system will be able to continuously monitor a closed area, such as a hospital waiting room, scanning for the presence of airborne droplets with the TB mycobacterium. Software based on AI will also provide support in terms of conditions of the closed room, local ventilation, and number of people, to more accurately identify TB avoiding false positives and negatives.  

The TBscan system will also consist of a handheld device than can directly scan the exhaled breath of an individual for the presence of TB. The handheld device could be used to identify the infected individual and could be used by itself even in open areas.

The target population for TBscan includes healthcare workers and medical doctors working in hospitals and healthcare centers but also in other environments of concern, e.g. refugee centers. These individuals are the most vulnerable to being infected by carriers of active TB as there is no early-warning system to detect TB in air. We have requests from three Directors of Pulmonary Clinics in Thessaloniki, Greece for TBscan for broad use, from private offices of Doctors to public waiting rooms. In fact the Hellenic Chest Diseases Society, HCDS, are directly supporting our efforts. 

The TBscan solution would provide increased protection to healthcare workers, doctors, and other patients. It will also provide early detection of those infected with active TB who can then be isolated (preventing disease transmission) and then benefit by early treatment of TB. We continue to work closely with the Pulmonary Doctors of HCDS, two are advisors in our company, RespiFit, and have already secured access to negative-pressure labs at the Papanicolaou General Hospital for conducting future tests with deactivated TB mycobacteria.

As TBscan is implemented in the field we will continue to gather evidence directly from the medical professionals, e.g., regarding the user-friendliness of TBscan and the accuracy of its results. For example, using TBscan in a hospital waiting room setting when a positive signal is obtained for the presence of someone in the room who has active TB what is the course of action? Do we isolate each person? Do we use a single-person version of TBscan that scans the exhaled breath of an individual? Will the procedure and necessity be clear to patients and healthcare personnel?  These practical issues may influence how our potential customers view TBscan and will be resolved during the actual application of the system by observing and interviewing personnel and patients about their interactions and the TBscan system.

There are many other areas where TBscan could be employed, e.g., in Transport security (e.g., airports), Education (e.g., classrooms), Military (e.g., barracks, submarines) and thus the range of customers could be much broader.  These are all different sectors with different specific needs and evidence will be gathered again directly through interviews and by understanding the specific constraints of each application.

One area that is of interest to the medical community is controlling TB in communities of refugees who are especially vulnerable to the different strains they encounter in host nations due to their depressed immune systems. This has become a significant problem in countries of the Eastern Mediterranean due to tecent war and crises in the Middle East opening a pathway to refugees as well as illegal immigration from other nations. Refugees, with impaired immune systems are especially vulnerable to TB transmission and even latent TB can become activated.
(see Boyd et al. 2019 and Ismail et al. 2018  )

We have access to such refugee camps based on HCDS and also personal contacts with Municipalities, e.g., Thessaloniki, where such refugee camps are located. In this area the customers would be government organizations responsible for the refugee camps and the regional Municipalities where they are located. The benefits, are establishing healthier and safer refugee camps and minimizing possibilities for cross-infections of healthcare workers. Consequently, camps, welcome centers, and health facilities for refugees are also of special importance for us.  

TBscan is perfectly aligned with the Health Security and Pandemics Challenge.

The TB problem is a huge health issue, killing more than 1.4m people every year, mostly in under-developed nations. TBscan is an innovative tech solution that aims to benefit those most vulnerable to TB transmission, i.e., refugees, healthcare workers and medical doctors.

TBscan may be applicable to other bacteria and, possibly, even viruses (with a significantly different optical system). Even if TBscan is only applicable to TB the result will be to save an enormous number of lives of underprivileged people in nations every year.

We selected Prototype because we are well beyond the concept stage. We have a small fund from Hellenic Chest Diseases Society, have completed the design of all the proof of concept tests and have initiated work with the laser laboratory lab of Prof. Kosmidis at the Dept. of Physics in the Univ. of Ioannina, Greece, where we are developing and testing the first prototype.We have also initial designs for the flow device which are part of a provisional USpatent that was recently submitted. 

TBscan is innovative because it is the first ever solution for instantly detecting TB dispersed in air. The only solutions proposed for detecting TB dispersed in air are based on solutions that collect a large number of droplets from air over a long period of time and then examine them by the normal microscopy/culture approach employed for biological samples obtained from patients, e.g., fluorescent microscopy.

TBscan identifies the presence of the TB mycobacterium in seconds compared to other approaches which take from days to weeks. TBscan can identify quickly the infected individual. Other approaches cannot. Because, for example, in a hospital waiting room hundreds of people will have come and gone before any result can be obtained by a collection and microscopy method.

With TBscan the infected individual can be identified quickly and isolated, protecting other patients, healthcare workers, and doctors.  

After implementing TBscan in the healthcare sector we will pursue other applications in airport security, military, schools. There is also a potential to employ the TBscan technology for some other bacteria and even viruses which we shall investigate.  

For healthcare workers
Currently = 0
In one year = 10 (pilots)
In five years = 10,000 (rapid growth globally)

For people with TB
Currently = 0
In one year = 1,000
In five years = 1,000,000 (rapid growth globally)

We have secured a significant interest from the Medical community. Even though TB is not a huge problem in Greece it is still present and in the past it was much more prevalent. Indeed the collaborating Hospital of Papanikolaouin Thessaloniki was the key sanatorium for people with TB just a few decades ago. This history is very recent and the concerns of healthcare professional is very real and sincere.

We are in the process of implementing the proof of concept experiments which should finish during the summer.

We have just begun to make some first contacts with India among which we expect to continue to grow over the next year.

Concerning the impact of TBscan once it is deployed in the field the KPI for us will the following:
1. the number of positive events
2. the number of individuals identified as having TB
3. the ratio of the number of individuals identified as having TB who are then verified to actually have TB. (true positives)

Two (Christodoulos and Aleck both part time - Founding Team of RespiFti)

Two students at the Univ. of Ioannina in Greece (Laser Lab of Prof. C. Kosmidis at the Dept. of Physics) are involved in the proof of concept studies.

Two Advisors (Panagiotis and Stavros) both Directors of Pulmonary Clinics

The team consists of:
Christodoulos Spagakas, Co-founder,- CEO of RespiFit
Aleck Alexopoulos, Co-founder - CTO of RespiFit
Prof. Constantine Kosmidis from the Univ. Ioannina in Greece, Director of the laser lab in the Physics Department.
Our two advisors, i.e., Panos Chatziapostolou and Stavros Tryfon, are both Director of Pulmonary Clinics in Thessaloniki, Greece, i.e., Euromedica, and the Papanikolaou General Hospital, respectively.

Christodoulos and Aleck formed RespiFit after participating in the MIT Enterprise Forum Startup Competition in Greece in 2017. RespiFit was formed with the initial goal of developing an intelligent monitoring system for people with asthma.

During discussions with our advisor Doctors they asked if we could somehow solve a key problem they had with TB. "When patients come to our offices coughing we are always afraid that it might be TB" they said. Active TB can be very transmissive and the treatment if infected takes weeks and months and involves several drugs with sometimes severe side-effects. This would very harmful for a Doctor's health and their practice. It was from these discussions that the idea for TBscan was created.

RespiFit committed to building a diverse, equitable, and inclusive team.

In the Asthma project RespiFit has a collaborating female Electrical Engineer from the University of Western Macedonia, Greece. In EU research projects that RespiFit has participated the percentage of female participants was significant, e.g., 32-41%.

We plan to recruit new members of the team following an open equitable philosophy.

Solve focuses on tech innovations for Global Challenges.

TBscan is a very innovative and tech-oriented solution that can improve biological safety worldwide and help the WHO achieve its goals to significantly reduce TB by 2030. WHO’s EndTB program can be greatly assisted by detecting both the presence of TB in air earlier and also by identifying, isolating, and treating the TB carriers earlier. In this way, TB transmission is significantly reduced both at the source and the target levels.

The Pulmonary Doctors working with RespiFit have expressed the personal fears on a resurgence of TB and their daily concern when meeting any patient with a cough that might turn out to be TB.

There is also a pressing humanitarian aspect as TB is prevalent among refugees due to their depressed immune systems, crowded and poor living conditions, but also due to their decreased protection to the TB variants they are exposed to in their host nation. Gene transfer between TB variants in co-infected individuals is possible and could lead to new more potent and drug resistant forms of TB.

For all these reasons we believe TBscan is a perfect fit for MIT Solve.

Our key needs right now are support for product development (funding and technical) and immediately after that support (funding and marketing) for promotion and distribution of the product. A major Pharmaceutical firm in Greece has expressed interest in collaboration but we will decide only after the prototype is ready.

We have the support of the community of Pulmonary Doctors in Greece and several are active at the European level. After deploying the product to Hospitals in Greece we will seek to scale to hospitals in India. We will need support on several fronts with this as well but have already started making some contacts with Health professional in India. All our efforts can be expedited significantly with funding and hiring of a Business manager to oversee the company and expansion to markets. The co-founders of RespiFit wish to focus on product development.

We would like to connect with the Bill and Melinda Gates Medical Research Institute (link) as TB is one of their key interests

Among the faculty of MIT we would be interested in connecting with people with expertise in medtech and entrepreneurial experience who can help secure funding and establish more credibility.
We have identified: Dr. Gregory Martin (link) 
Also an MIT Alum active in Medtech in the Boston area
Mr. Sanjay Manandhar (link)

Among the Solve team we would like to connect with Pooja Wagh because of compined technical background and also experience in promoting healthcare/medtech solutions.

TBscan can help protect the health of and well-being of people in the US in two ways.

One way is indirectly by improving the health and biosafety of people worldwide with respect to TB.

The other is by directly protecting healthcare workers and patients in hospitals from TB outbreaks. Although this is considered a secondary problem in the US, drug resistant forms of TB are on the rise, immigration from nations with high rates of TB continues, and outbreaks do occur (for example: https://www.cdc.gov/mmwr/previ...).

The Robert Wood Johnson Foundation Prize would be used to proceed from the Proof of Concept to the early prototype for TBscan.

TBscan has a strong focus on refugee health and wellness which is a prerequisite for inclusion and acceptance. We wish to finish developing the TBscan prototype and then test in the field both in hospital waiting rooms but also at refugee camps and refugee welcome centers.

Refugees are especially susceptible to TB due to their depressed immune systems but also due to their sensitivity to the different strains of TB encountered in the host nation. Refugees infected with TB can easily transmit to other refugees and even refugee aides and health care workers.

This is a critical issue as the last thing a refugee needs is to be encumbered with an infectious disease that can take months of isolation and pharmaceutical treatment to recover. Moreover, refugees will be much more unlikely to find a nation to accept them while they suffering from active TB.

We wish to test TBscan to detect TB at different settings including hospital waiting rooms and refugee camps.

After deployment in Greece we wish to scale to India where TB is a significant problem. We wish to examine several means to promote TBscan and respiratory health via healthcare and social workers as well as teachers both by educating the public but also by convincing officials to install the TBscan system in e.g., hospitals, school rooms etc. We believe that women in India could play a key role in these efforts as they are most directly impacted by the treatment of infected people with TB.

The TBscan system will also include an AI system to improve detection of TB in air but also in exhaled breath.

The AI system will consider environmental conditions, e.g., temperature, humidity, the microparticulate load and connect to previous correct detections. Correlations between similar regions and settings will also be considered to enhance the performance of TBscan and decrease the number of false positivities and negatives.

A more ambitious aspect of the AI system would be to tract TB variants in people and different regions and then through classification use this data to not only make more accurate assessments of infections but also detect genetic exchange between variants that could lead to more infective and drug-resistant TB variants.