Molbio Diagnostics and ShanMukha Innovations have collaborated to design, develop and commercialise point-of-care diagnostic devices to diagnose haemoglobin-related diseases.

ShanMukha Innovations is an Indian Institute of Science (IISc) spin-off that specialises in creating mobile diagnostic solutions.

It has developed SickleCert, a first-of-its-kind indigenous point-of-care confirmatory test in the country for quantitative detection and differentiation of sickle cell disease/trait, according to a Molbio note. The platform will also be able to soon test for Anemia and Thalassemia, it added.

SickleCert’s components including the portable analyser (HaemoCube) and consumables were developed by researchers at the IISc. A companion smartphone application enables digital data recording, analysis, and integration with various registries such as Ayushman Bharat Health Account (ABHA) and other cloud-based patient health record systems, it explained.

Molbio will help ShanMukha with the development, manufacturing, and commercialisation of the platform.

What is sickle cell disease?

Sickle cell anemia is a genetic disorder, characterised by an altered haemoglobin structure, which causes flexible red blood cells to become stiff sickle-shaped cells, leading to debilitating effects like obstruction of blood flow, oxygen deficiency, and an increased risk of organ damage.

The condition affects an estimated 10 percent of India’s tribal population, which has far-reaching negative consequences in terms of their economy and general well-being, the note said.

Because sickle cell anemia is an inherited condition, a person with sickle cell trait only inherits one defective gene, whereas people with the disease inherit two defective genes, one from each parent.

Tool functioning

The diagnostic tool uses technology based on High-Performance Optical Spectroscopy (HPOS) and demonstrates high accuracy in clinical evaluations, it said.

“HPOS provides an affordable and efficient solution to screen large populations as a point-of-care quantitative diagnostic test. With a tiny amount of blood from a finger prick, the test provides highly accurate results in 15 minutes. In batch mode, over 40 samples can be tested in an hour enabling a large volume of screenings to be completed in a much shorter time span,” it added.

Further, it said, the test had been approved by the Indian Council of Medical Research, and recommended by the Department of Health Research as a cost-effective field solution for National Health Mission programs.

The government has announced a ‘National Sickle Cell Elimination Mission’ to eradicate the disease from the country by 2047. The mission plans to screen seven crore people across 17 States over the next three years as a first step.