BabyCue

Childhood diarrhea is a second serious public health concern with >63% global prevalence (~40-50% cases, causative organism cannot be identified), killing ~5,25,000 children/year, especially <2 years, despite simple treatment availability. In developing countries including India, its average occurrence is thrice a year with death rate of approximately 9-9.5%, claiming 300 lives/day. Global prevalence rate of childhood diarrhea is 1.7 billion cases every year (i.e., 63 of which 40-50 cases, causative organism cannot be identified) with mortality rate 5,25,000 children/year, especially 2 years. In India, the prevalence is 3 times a year with mortality rate of 19.5, claiming 300 lives/day (1 lakh children/year). The main reasons are poor sanitization, inadequate drinking water, child-growth failure, antibiotic overconsumption due to unavailability of early point-of-care facility to differentiate diarrhea, leading to increasing deaths patterns, antimicrobial resistance (AMR) events and treatment cost. Thus, there is an urgent unmet need to combat increasing cases by introducing early diagnosis tool for differentiating diarrhea helping in clinical decision-making to prescribe definitive treatment.

Our disposable point-of-care microfluidic-paper analytical device (µ-PAD) based test-platform can be an early diagnosis tool that will, potentially, help in differentiating childhood diarrhea (≤5 years) i.e., bacterial diarrhea from viral diarrhea. It will improve clinical decision-making appropriateness, streamline resource allocation, and adverseness associated with injudicious medication usage. Our µ-PAD based diarrheal detection kit is non-invasive, rapid-on-site infection detection, cost-effective, bio-degradable, qualitative and quantitative measurement of biomarkers in fecal samples with color changing visualization. Increased levels of fecal biomarkers detected from diarrheal detection kit can further be correlated well with both endoscopic and histological assessment of disease activity. Since, the device is designed ergonomically with simple lateral flow assay technology, it requires low-throughput settings and eliminates the need of sophisticated instruments in affected areas. Measurement of responsible biomarkers using this rapid diarrheal detection kit can be considered as a reliable indicator of inflammation and can facilitate clinical decision-making for the infection treatment, such as deciding whether to prescribe antibiotics or not.

As, India is among the major contributors of infant diarrheal cases, the antibiotic prescription rate is higher, thereby uplifting AMR events, leading to increase in treatment cost. There are no primary detection kits available in market for differential diarrheal infection among infants. The µPAD-based detection kit will be a testing platform for early immuno-diagnosis of bacterial diarrhea among infants with fast turn-around time of 5-7 minutes under lower throughput requirements in clinics, hospitals and laboratories as a point-of-care option. Hence, this can support in clinical decision-making for treatment i.e., if viral diarrhea, ORS and nutrition therapy and if bacterial diarrhea, antibiotic treatment prescribed by clinicians. It will eliminate the need of sophisticated instrumentation that are non-available or less available in remote target regions, very cost-expensive, demands high-throughput setups, skilled manpower, complex procedures that can consume time and will take 24-48 hours to generate reports. This will be truly beneficial for the lakhs of rural and low-resource settings, where last mile health workers i.e ASHA, Auxiliary Nurse Midwife Anganwadi Workers in India, they can administer drugs after conducting the test through this instant diagnostic kit.

Our team at BabyCue comprises highly skilled individuals with diverse backgrounds and expertise, ensuring that we are well-positioned to deliver our solution effectively.
With Manish Kumar Swain leading as the Founder and a BIRAC-SPARSH SIIP Innovation fellow, we benefit from his extensive experience in clinical practice and innovation. Our Co- Founders, including Itishree Jali and Sweety Kaur, further enrich our team with their specialized knowledge in biotechnology and microbiology, respectively. Their dedication to product development and research underscores our commitment to delivering high-quality solutions.

Additionally, Rishika Kedia oversees HR and Admin, leveraging her MBA in Finance & Human Resource, ensuring smooth operations within the organization. Sefali Maurya and Rhythm Karir contribute their expertise in biotechnology to research, development, and product enhancement.

Furthermore, our team is supported by esteemed mentors, Dr. Amit Asthana and Mr. Asim Syed Sheeraz, who bring invaluable guidance and expertise to our technical and strategic endeavors. Dr. Asthana's background as the HoD of the Department of Medical Devices at NIPER, Hyderabad, and Mr. Sheeraz's role as the CEO of Yenepoya Technology Incubator, provide us with invaluable insights and direction.

In summary, our team's collective expertise, dedication, and guidance from mentors ensure that we are well-equipped to deliver our solution effectively, meeting the needs and expectations of our stakeholders.

We've completed a trial consisting of 100 tests, during which the results obtained from our kit aligned with test currently in use. Collaborating with NIPER, we conducted our Lab Scale Validation, and partnered with hospitals for on-site validation.

I am applying because it offers comprehensive support beyond just financial aid. While the grant, pitching opportunity, and prize pool are appealing, the nine-month support program and valuable connections are what truly attract me.It presents an opportunity for mentorship, guidance, and technical assistance that can significantly aid in overcoming any hurdles that we might face. 

Additionally, the connections and access to portfolio funding offered by this platform can help validate my solution in the market and provide the necessary resources to scale and implement it effectively.

There are no such PoC devices in the market that focuses on the detection and differentiation of bacterial diarrhea from the viral diarrhea among infants and children under age 5 using microfluidic paper analytical devices (µ-PADs), derived from chromatography paper. Though, there are some detection kits available in the market (however, not in India) that can detect inflammatory bowel disease (IBD), a different type of gut infection, which attains prevalence rate of <1% among infants. Our µ-PAD based diarrheal detection kit is non-invasive, rapid-on-site infection detection, cost-effective, bio-degradable (eco-friendly), qualitative and quantitative measurement of biomarkers in fecal samples with color changing visualization. Increased levels of fecal biomarkers detected from diarrheal detection kit can further be correlated well with both endoscopic and histological assessment of disease activity. Since, the device is designed ergonomically with simple lateral flow assay technology, it requires low-throughput settings and eliminates the need of sophisticated instruments in affected areas. Measurement of responsible biomarkers using this rapid diarrheal detection kit can be considered as a reliable indicator of inflammation and can facilitate clinical decision-making for the infection treatment, such as deciding whether to prescribe antibiotics or not.

As, India is among the major contributors of infant diarrheal cases, the antibiotic prescription rate is higher, thereby uplifting AMR events, leading to increase in treatment cost. There are no primary detection kits available in market for differential diarrheal infection among infants. The µPAD-based detection kit will be a testing platform for early immuno-diagnosis of bacterial diarrhea among infants with fast turn-around time of 5-7 minutes under lower throughput requirements in clinics, hospitals and laboratories as a point-of-care option. Hence, this can support in clinical decision-making for treatment i.e., if viral diarrhea, ORS and nutrition therapy and if bacterial diarrhea, antibiotic treatment prescribed by clinicians. It will eliminate the need of sophisticated instrumentation that are non-available or less available in remote target regions, very cost-expensive, demands high-throughput setups, skilled manpower, complex procedures that can consume time and will take 24-48 hours to generate reports. This will be truly beneficial for the lakhs of rural and low-resource settings, where last mile health workers i.e ASHA, Auxiliary Nurse Midwife Anganwadi Workers in India, they can administer drugs after conducting the test through this instant diagnostic kit.

SDG 3- Good Health and Well Being

Global prevalence rate of childhood diarrhea is 1.7 billion cases every year (i.e., 63 of which 40-50 cases, causative organism cannot be identified) with mortality rate 5,25,000 children/year, especially 2 years. In India, the prevalence is 3 times a year with mortality rate of 19.5, claiming 300 lives/day (1 lakh children/year). Thus, there is an urgent unmet medical need to combat increasing cases by introducing early diagnosis tool for differentiating diarrhea that will help in clinical decision-making to prescribe definitive treatment. Our device will be highly specific in detecting the responsible biomarkers directly from patient fecal samples. Economical pricing and practical use in treatment will ensure it a must have device and bring revolution in the field of PoC devices, and will help industries in attaining commanding position in the market, good return of investment with low-risk route to the market due to cheap and eco-friendly substrate source.

Our point-of-care µ-PAD test platform follows the lateral flow immunoassay technique which utilizes antibodies for diagnosis of bacterial diarrhea.

[1] https://data.unicef.org/topic/child-survival/under-five-mortality/

[2] https://data.unicef.org/topic/child-health/diarrhoeal-disease/

[3] https://www.who.int/news-room/fact-sheets/detail/diarrhoeal-disease

[4] Ghosh K, Chakraborty AS, Mog M. Prevalence of diarrhoea among under five children in India and its contextual determinants: A geo-spatial analysis. Clinical Epidemiology and Global Health. 2021 Oct 1;12:100813.

[5] Kamath A, Shetty K, Unnikrishnan B, Kaushik S, Rai SN. Prevalence, patterns, and predictors of diarrhea: a spatial-temporal comprehensive evaluation in India. BMC Public Health. 2018 Dec;18(1):1-0.

[6] Paul P. Socio-demographic and environmental factors associated with diarrhoeal disease among children under five in India. BMC public health. 2020 Dec;20(1):1-1.

[7] Lakshminarayanan S, Jayalakshmy R. Diarrheal diseases among children in India: Current scenario and future perspectives. Journal of natural science, biology, and medicine. 2015 Jan;6(1):24.

[8] Levine MM, Nasrin D, Acácio S, Bassat Q, Powell H, Tennant SM, Sow SO, Sur D, Zaidi AK, Faruque AS, Hossain MJ. Diarrhoeal disease and subsequent risk of death in infants and children residing in low-income and middle-income countries: analysis of the GEMS case-control study and 12-month GEMS-1A follow-on study. [9] The Lancet Global Health. 2020 Feb 1;8(2):e204-14.

[10] Mokomane M, Kasvosve I, Melo ED, Pernica JM, Goldfarb DM. The global problem of childhood diarrhoeal diseases: emerging strategies in prevention and management. Therapeutic advances in infectious disease. 2018 Jan;5(1):29-43.

[11] Prasad KS, Cao X, Gao N, Jin Q, Sanjay ST, Henao-Pabon G, Li X. A low-cost nanomaterial-based electrochemical immunosensor on paper for high-sensitivity early detection of pancreatic cancer. Sensors and Actuators B: Chemical. 2020 Feb 15;305:127516.

[12] Jiang X, Fan ZH. Fabrication and operation of paper-based analytical devices. Annual review of analytical chemistry. 2016 Jun 12;9:203-22.

[13] Jacobson, R. H. (1998). Principles of validation of diagnostic assays for infectious diseases.

[14] Wang Y, Wang H, Khan MS, Husain FM, Ahmad S, Bian L. Bioconjugation of gold nanoparticles with aminoguanidine as a potential inhibitor of non-enzymatic glycation reaction. Journal of Biomolecular Structure and Dynamics. 2021 Mar 31;39(6):2014-20.

Number of people working on at BabyCue are:

Manish Kumar Swain - Founder, M. Pharm (Hospital and Clinical practice), BIRAC-SPARSH SIIP Innovation fellow
Rishika Kedia - Head- HR and Admin, MBA (Finance & Human Resource)
Sefali Maurya - Associate- Research & Development, M.Tech (Biotechnology)
Rhythm Karir- Associate- Product Development, M.Sc (Biotechnology)

Itishree Jali - Co- Founder, Head- Product Development, PhD(Biotechnology),CSIR-SRF Fellow
Sweety Kaur - Co- Founder, Head- Research &  Development, M. Sc (Microbiology) with total 8 Research publications

Dr. Amit Asthana- Mentor- Technical, HoD, Department of Medical Devices, Associate Professor, NIPER, Hyderabad
Mr. Asim Syed Sheeraz- Mentor-Product & Strategy, CEO Yenepoya Technology Incubator

Manish Kumar Swain, the Founder, was awarded the Sparsh SIIP Fellowship in August 2020. Since 2021, he has been diligently developing this solution, and with over three years since registering the company, we have achieved a Technology Readiness Level (TRL) 4.

To ensure diversity, minimize barriers to opportunity, and cultivate a welcoming environment, our team employs inclusive hiring practices, such as outreach to diverse talent pools. We provide ongoing diversity, equity, and inclusion training to foster awareness and understanding among all employees. Open communication and collaboration are encouraged to promote inclusivity, and we celebrate the unique contributions of each team member. Flexible work policies accommodate various needs, and regular feedback mechanisms ensure that our diversity and inclusion efforts remain effective and responsive to evolving needs. Additionally, we ensure that diversity is reflected at all levels of the organization, including leadership positions.

The market entry and commercialization aspect will be based on the B2B, B2C and B2G strategy. The final product could be sold to hospitals, clinics, diagnostic laboratories, PHCs, CHCs, public institutions and other individual stakeholders. The end product will be marketed as a complete and modular solutions keeping in mind the affordability of different user segments.

We have received grants upto 80.9 Lakh

MBIRAC-SPARSH SIIP kickstart grant - 5 lakh
DST-NIDHI PRAYAS - 10 lakh
BIRAC BIG - 50 lakh
STARTUP ODISHA - 2.4 lakh
MSME - 13.5 lakh

Won the 1st Prize of Rs 1 lakh at Social Venture Challenge organised by Tata Institute of Social Science
Won Innovators Connect Tandem 2023 programme and are invited to Germany for The Indo-German Start-up Camp.
Received certificate of appreciation from Startup Odisha for availing financial assistance during Startup Odisha intiative of 2023-24
We have successfully achieved our milestones so far and are planning for further advancement.