Mumbai, September 8
A one-minute rapid diagnostic test for malaria, costing about a dollar, is up for regulatory review in India.
The developer of low-cost diagnostics devices, Hemex, has developed this ‘Gazelle’ platform that claims to differentially diagnose both Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) in a single blood sample.
The diagnostic component is going through the regulatory process with the Central Drugs Standard Control Organisation and a license to market is expected in a couple of months, said Poornima Kumar, Managing Director, HemexDx (India). It is a multi-disease platform, and in addition to sickle cell disease and malaria, it is being developed for thalassemia and Covid-19 too, she said.
The device uses magneto-optical detection of hemozoin, a metabolite produced by malaria parasites within red blood cells that is immune to genetic mutations, which, in turn reduce diagnostic accuracy in other tests. The company is conducting clinical studies in India with the National Institute of Malaria Research (New Delhi) and the National Institute of Tribal Health, an ICMR (Indian Council of Medical Research) institution.
“The novelty of the device lies in its target price of $1 to make it affordable for tier 2 and 3 markets, one-minute testing of both Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) in a single blood sample,” said Kumar.
Responding to queries on the accuracy of the test, she said, “In clinical studies it has been shown to be as accurate as expert microscopy (which means significantly more accurate than an average microscopist.) It is also much faster (one-minute test) compared to microscopy (30-45 minutes).
It finds many more cases than rapid tests (or kits) of Plasmodium vivax malaria, the second-most common type of malaria in India.
HemexDx India is the subsidiary of United States-based Hemex Health. And the Gazelle technology was developed in collaboration with Case Western Reserve University, according to a note from the parent company.
The India Health Fund (IHF) is supporting HemexDx in the development and validation of the specific algorithm for differentiation in species — Pf and Pv — and in wider deployment post approval.
IHF is an initiative led by Tata Trusts along with Global Fund to Fight AIDS, Tuberculosis and Malaria. It focuses on addressing the gap in funding, especially in infectious diseases, to bring out cost-effective solutions, said Madhav Joshi, IHF Chief Executive.
Web of partnerships
Joshi
explained that the base technology comes from the US university. However, identifying the potential for an application to be used in a portable device was done by the company.
That aside, there is a web of partnerships in India. The Gazelle device is made in India and developed in collaboration with Tata Elxsi (Pune), with the software engineers at Tata Elxsi designing the device for the platform, Kumar said. It is being manufactured at Robonik India, located near Ambernath (on the outer fringes of Mumbai). The cartridges are manufactured at Lakshmi Lifesciences, Coimbatore. Gazelle will be distributed exclusively in India and other regions by US-based medical devices company Bio-Rad Laboratories, she added.