India Health Fund (IHF)-supported rapid multi-diagnostic test, ASSURED, developed by Ameliorate Biotech Pvt. Ltd, has received approval for manufacturing and marketing from the Central Drugs Standard Control Organisation (CDSCO). The first-of-its-kind “Made in India” test can swiftly and simultaneously detect dengue, malaria (including vivax and falciparum differentiation), chikungunya and their co-infections using a single blood sample in under 15 minutes and can be easily used by a minimally trained workforce at the primary care level. This approval now paves the way for large-scale product manufacturing and launch in the market.

Dengue, malaria, and chikungunya pose a major global health challenge, accounting for 17% of all infectious diseases and causing more than 700,000 deaths each year, with India bearing a disproportionate share of the burden. Co-infections further complicate diagnosis because these diseases often co-circulate, are spread by the same mosquito vector, and present similar early symptoms such as fever, thrombocytopenia, and organ dysfunction. This increases the risk of misdiagnosis, missed diagnosis, and delayed treatment. Long turnaround times, dependence on skilled personnel, lack of access to multiple diagnostic tools and advanced testing equipment especially in rural and remote areas, and the high cost of testing each disease separately further worsens the problem. Climate change is also accelerating the spread of vector-borne diseases by affecting vector breeding and feeding patterns through rising temperatures, humidity, and shifting rainfall, thereby expanding transmission seasons and geographic range.

Plugging these gaps, Ameliorate Biotech Pvt. Ltd. developed ASSURED – an accurate, multiplexed RDT for the simultaneous detection of dengue, chikungunya and malaria (with malaria falciparum and vivax differentiation). India Health Fund supported Ameliorate Biotech to conduct an open label, multicentric, performance and cost-effectiveness evaluation of the rapid antigen-based diagnostic kit. This multicentric evaluation was completed across three CDSCO-approved centers, namely RMRIMS (Patna), Rajiv Gandhi Institute (Srikakulam), and KLES’s Dr. Prabhakar Kore Hospital (Belagavi).  With sensitivity and specificity being 99.34% and 100% respectively, ASSURED is now gearing up for manufacturing scale-up, setting up stringent quality control processes, distribution pipelines, and supply chain logistics. It also addresses critical healthcare inequities by being accessible, affordable, widely available, and acceptable, thereby optimizing healthcare delivery.

Supporting novel diagnostic innovations such as ASSURED, India Health Fund remains committed to strengthening health systems and accelerating impact at the last mile.

Leader’s Speak:

Madhav Joshi, CEO, India Health Fund:

“This approval is more than a regulatory milestone. The announcement brings powerful diagnostics significantly closer to reaching the hands of those who need it the most. It’s a victory for accessible game-changing diagnostics and a win for investing patient capital in innovations for infectious diseases”.

Dr. Binita Tunga, Co-founder, Ameliorate Biotech Pvt. Ltd:

“The road to approval has been rigorous, and now the approval from CDSCO marks a major milestone in the project. This is a moment where years of relentless research, millions of INR of patient capital from our funders, and the trust of our partners begin to bear fruit. We are not just launching ASSURED in the market; we are setting a new standard for accessible, rapid, platform tests for vector-borne diseases”.