Medupi by Drizzle Health, LLC

Tuberculosis (TB) is the leading infectious disease killer, after Covid-19, resulting in almost 1.6 million deaths worldwide every year. An estimated  56% of TB cases are bacteriologically confirmed, making underdiagnosis a major contributor to the ongoing TB transmission. Further, studies have shown that it can take about 4-6 weeks before patients get a TB test.

Medupi is a low cost, high performance instant screening device that can be carried around by CCWs, or be accessed at primary health centers of any kind, that instantaneously provides results to the clinician so that patients can be immediately included into TB treatment and follow-up regimes and prevent community transmission.

With instant results, our network of devices will be able to map outbreaks and 'hot' areas in real-time, leading to maximum efficiency in efforts and aid to already overburdened government TB programs. Control of local outbreaks will dramatically reduce recurring cycles of community transmission.

Tuberculosis(TB) is the leading infectious disease killer, after Covid-19, resulting in almost 1.6 million deaths worldwide every year. The identification of Mycobacterium Tuberculosis is essential in diagnosing TB. An estimated only 56% of TB cases are bacteriologically confirmed, making underdiagnosis a major contributor to the ongoing TB transmission. Further, studies have shown that it can take about 4-6 weeks before patients get a TB test. 

Essentially, a large number of patients go undiagnosed or misdiagnosed for long periods, during which they spread the disease in their family, communities, and those they come in contact with. 

In recent years, highly sensitive NAAT based tests have been introduced in high burden countries. However, these machines, due to their costs and maintenance, are generally centralized. With each test costing about $10-15, and unequal access amongst clinicians within cities, most clinicians clinically diagnose TB, often with CXRs and results of Sputum Smear Microscopy(SSM), which is only about 55% sensitive. In India, notifications fell back to 2017 levels after Covid-19, where there are over 20,000 SSM centers and only 3000 NAAT machines.

Medupi focuses on 2 parts of this problem - 

(1) Low total time for the patient to get diagnosed (not just the testing tim

(2) Low cost to find and test each patient.

Medupi is a 2 part system that utilizes sputum as the sample collected in a cartridge and an electro-optical reader system for detection.

The cartridge contains a highly specific surface that specifically captures mycobacteria from samples in contact. The workflow is as follows:

1. CCWs visit vulnerable populations (including slums, migrant workers, etc.) and collect sputum samples from presumptive patients in sputum cups. A liquefaction buffer is introduced into these cups and left to incubate for 10 minutes while the CCW fills out details for the group of patients.

2. Using a disposable pipette dropper, the CCW transfers a sample into the cartridge's reservoir. The cartridge includes a syringe that pulls the sample from the reservoir, onto the surface. The pipette and syringe are disposed into a biosafety bag.

3. The cartridge is then inserted into the Medupi reader, where the chip is read using optical and electrical signals, specific to mycobacteria. Due to the high specificity of the surface, and the epidemiological setting, very low concentrations (i.e. early stage and HIV patients) can be detected. Results return within a minute.

4. Cartridge is discarded into biosafety bag.

5. Medupi device instantly uploads numbers into a real-time map via internet.

Our Team has established partnerships in India, which has the highest TB burden in the world. Apart from routine patients visiting primary health care clinics (including lower and middle income patients in rural, peri-urban and urban areas), we will focus on piggybacking on the government's existing active case finding efforts through CCWs, as well as CCWs in the field for routine screening of other diseases. Vulnerable and neglected populations include migrant workers, people living in slums, prisoners, HIV infected patients, contacts of diagnosed TB patients in Tier - 2, and Tier - 3 cities, as well as villages.

Our solution focuses on the dimensions of equipping last mile primary health providers with tools to not only detect TB and follow-up presumptive populations as leg workers following orders, but also directly strengthening TB surveillance timely, to be able to control local outbreaks.

We feel that LMIC health systems are unique and cannot copy western models of care in sustainable ways - (National economics bounding public healthcare expenditure, reliance on aid, patient economics and behavior and pure environmental costs of replication of western models). 

CCWs are the core foundation of LMIC healthcare systems. Our devices are meant to empower CCWs.

We already have an IRB study in place (delayed due to Covid-19) to study the efficacy of part of the Medupi system in India. This is expected to be completed before September.

The Medupi cartridge was designed keeping current TB pathways followed around the world in mind, and thus, also works with sputum smear microscopy (SSM). It was presented to the Indian Council of Medical Research as well as State Health departments who keenly appreciated the lab performance and invited the team to conduct studies at their sites, before pilots.

The Medupi reader has been tested for proof of concept in the lab (with contrived samples), and is currently undergoing more rigorous testing, as well as human centered industrial design. 

The Medupi cartridge has been thoroughly tested in the lab. An early version of the technology was tested in Uganda, where it demonstrated 93% sensitivity when used with SSM. 

Behavioral insights:

1. Time for patients to get into the TB treatment system - This takes 4-6 weeks. Most products are lab based and thus do not focus on this part.

2. Cost for each test - Cost per test needs to be low enough so that it is realistic for state and central governments to not just test, but over test over long periods.

3. Existing infrastructure (including personnel who've already been trained) - Governments invest in infrastructure over decades. Faster and wider deployment requires fitting into existing infrastructure.

4. Patients habits (delay in going to doctor, going to small facilities first) - Are not going to change. Non urban patients will not suddenly change the way they access healthcare and go to central facilities or bear severe symptoms waiting for test results, or not be satisfied with alleviated symptoms (antibiotics prescribed at primary centers). Instant enrollment is key.

Technical insights:

1. Sample quality enhancement without additional steps to increase performance of existing tests is an underexploited part of the diagnostic pathway. Medupi cartridge concentrates the sample, enabling low limits of detection.

2. Specificity of SSM comes from differential staining (enough contrast) and technician's knowledge. Contrast can come from selective concentration and knowledge from peak analysis.

Our surveillance system will become stronger as more states, join the network. We anticipate that since our surveillance system will provide direct visibility to donors in the space, state governments are unlikely to forgo, and will enroll their state's CCWs in the program.

We currently serve zero people since we're in the testing phase. 

Within the next year, as part of clinical studies, we will be able to test 100-1000 patients using either the complete system or part of it.

Full development is expected to finish in the first quarter of 2022. Within the next 4 years, targeting the states of Rajasthan and UP in India, where the team met with health officials who expressed interest, we anticipate to affect 10-30 million screenings each year beginning 2023.

Current progress is being measured on the basis of lab results and product development timeline.

Once deployed, performance will be measured indirectly, yearly from TB incidence and notifications from India's Annual TB report for 2023, 2024 and so on, in accordance with SDG 3 indicators (October reports).

2 Full-time members

1 Contractor

1 Intern

3 Scientific advisors

The team has 2 full time members, Bonolo and Digvijay.

Bonolo has a background in biomedical and electrical engineering. Digvijay has a background in materials science and industrial design. They attended  the bioengineering program (CBID) at Johns Hopkins for their masters, as part of which they've conducted first hand observations and interviews in Brazil, South Africa, US and India. Coming from countries with very high TB populations, both Bonolo and Digvijay have seen first hand, the conditions of patients as well as the healthcare systems serving them. Despite carrying masters debts, they decided to work together on creating impact for TB stricken populations.

The team has 3 scientific advisors,

1. Yukari Manabe, MD - An infectious disease expert with over 20 years of TB experience

2. Soumyadipta Acharya, MD, PhD - A global health and medical device innovation expert

3. Hai-Quan Mao, PhD - A nanotechnology expert with over 20 patents 

The team has collected and assimilated over 100 interviews with stakeholders at various levels over the last 2 years and has incorporated inputs in design, strategy and impact of the products.

As a team, we firmly believe in acknowledging our differences in race, color, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, ancestry, and national or ethnic origin. It is only by acknowledging what makes us different, that we are able to truly embrace and celebrate our diversity. These differences govern how we uniquely experience the world and our decisions on when/how to access healthcare, the type of diseases endemic in our communities, medications available etc. and how we choose exercise our agency. 

Our goal is to fight TB and the destruction it is causing millions of lives around the globe each year. We understand that this is a fight where we'd need all the help we can get and need to rely on the best of each other.

The team's co-founders have differing backgrounds, Bonolo is South African and named the product Medupi, a Sepedi word that means quiet rain. Digvijay is an Indian national, hailing from the national capital region. 

We're applying to Solve to access funding and networks.

We're looking to fundraise to fuel R&D activities, finish clinical studies and cross the ICMR approval barrier in India over the next 12-18 months. 

We're looking to hire a full time engineer (Optics, electronics), part time QMS and manufacturing personnel. We would need help finding talent, as well as housekeeping and HR related activities.

We anticipate engaging a regulatory consultant (already identified) in Q2 2022.

There are about 10,000 cases of TB in the US each year. These disproportionately affect the homeless and immigrants. 

Further, the US receives over 75 million visitors each year (pre-covid19). Over 40 million Americans visit overseas. With over 1/4th of the world population carrying latent TB infection, the risk of TB exposure to American citizens from international travel is significant. However, currently no instant TB screening test exist that do not require significant management and storage. With the help of the Robert Wood Johnson Foundation Prize, we will be able to further the development of the test, as well as explore testing opportunities with airport authorities. This will also go a long way towards pursuing FDA submissions. 

The AI for Humanity prize will be used for the development of the Medupi reader - The reader uses optical signals that're analysed and matched with TB specific data. In the immediate future, we will develop a model that helps parse through noise, and low signal. However, in the coming years, we will look to leverage our platform to test for other sputum (or urine) sample based disease detection.