A Portable Diagnostic Platform Offering Affordable and Accessible Care

Project Overview

Creating affordable, life-changing medical diagnostics for more people everywhere is the mission of Hemex Health, a US-based in vitro diagnostic device manufacturer. Hemex Health collaborated with Tata Elxsi to develop an affordable, portable, and easy-to-use diagnostic device for malaria and sickle-cell anaemia disease detection based on two groundbreaking novel technologies.

The Problem

Today, 3.2 billion people are still at risk of malaria. As per the World Health Organization's 2019 malaria report, the world saw 229 million cases of malaria, which led to 405 thousand deaths. According to the WHO, there is a need for over 1 billion diagnostic tests per year to prevent avoidable deaths. Sadly, current diagnostics are time-consuming and may miss low-level infections, hence there is a need for highly sensitive yet affordable diagnostics. At the same time, over seven percent of the world’s population is at risk of inheriting hemoglobin disorders, including sickle cell disease (SCD) and thalassemia. 

As per the IHME global burden of disease 2017 data, over half a million babies suffered from sickle cell anaemia in Sub-Saharan Africa. Tragically, 50-90% of babies suffering from this disorder die before the age of 5 years. Early diagnosis could prevent tens of thousands of SCD child deaths each year.

The Solution

Tata Elxsi conducted extensive market research across India to gain insights into the potential of the product in developing markets, including market sizing, technology assessment, and user research.

To facilitate smooth R&D and commercialization, Tata Elxsi established a global engineering network with R&D and engineering centers in India and the US, along with a network of suppliers and vendors.

Collaborating with a dedicated R&D team, Tata Elxsi successfully developed a proof-of-concept that integrated and enhanced detection technologies into a compact and versatile platform for real-world applications.

Following successful clinical validation studies, Tata Elxsi embarked on product commercialization, which involved designing for manufacturing, assembly and testing, ensuring compliance with EU IVDR requirements, and establishing a manufacturing vendor ecosystem in India.

The Results

Gazelle is currently marketed in 25 countries. All Gazelle units and cartridges have been sold with slightly over half in India and the others primarily in Africa, the Middle East, and Europe. 

Over 215,000 tests have been sold for Gazelle for sickle cell disease since early 2021. The estimated impact is that Gazelle will have contributed to saving the lives of over 2000 children with early diagnosis.

Gazelle is the only solution in the world that can do point-of-care testing for beta-thalassemia. Early detection of traits well before marriage can significantly reduce the hardship on many families and eliminate the risk of infants born with serious diseases.

Services Rendered

• Market Research 
• Medical Device Engineering 
• Verification & Validation 
• Clinical Validation 
• Regulatory Compliance