Shanmukha Innovations and health-tech startup incubated by the Society for Innovation and Development (SID) at the Indian Institute of Science (IISc) on Monday announced that it has developed SickleCert, an indigenous diagnostic kit for Sickle-Cell Anemia.
A screening test kit called SickleFind has also been developed. The technology provides an affordable and efficient solution to screen large populations as a point-of-care test for Sickle-Cell Anemia, the company claimed.
“The technology called High-Performance Optical Spectroscopy (HPOS) consisting of test kits (SickleCert), portable analyzer (HaemoCube) was developed by researchers at the Indian Institute of Science (IISc). The technology has been licensed to a spin-off from IISc, ShanMukha Innovations Private Limited for commercialization. A companion smartphone application enables digital data recording, analysis, and integration with various registries, Ayushman Bharat Health Account (ABHA) and other cloud-based patient health record systems,” the company said in a statement.
Sickle-Cell Anemia is caused by a defective gene, Haemoglobin S, which causes flexible red blood cells to become stiff sickle-shaped cells, obstructing blood flow and increasing the risk of organ damage.
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.
Individuals with qualities tend to retain good health. The government has announced an ambitious National Sickle Cell Elimination Mission to eradicate the disease from the country by 2047 in the recent Budget. The Mission plans to screen 7 Crore people over the next 3 years as a first step.
“The technology we have developed provides an affordable and efficient solution to screen large populations as a point-of-care 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.” Prof. Sai Siva Gorthi, Principal Investigator, lead inventor of the technology, and Associate Professor at the Instrumentation and Applied Physics Department, Indian Institute of Science, said in a statement.
The Central Drugs Standard Control Organisation (CDSCO) approved the manufacturing license for SickleCert kits for ShanMukha Innovations Pvt Ltd as a Class C in-vitro diagnostic medical device in November last year.
In February this year, multi-centric field studies were successfully carried out as prescribed by the Indian Council of Medical Research (ICMR) across tribal districts in Madhya Pradesh and Maharashtra.
“The tests yielded an accuracy measure of 97.6%, with a sensitivity of 96.9% and a specificity of 98.6%. The field studies also confirmed the operational feasibility of the tests for point-of-care use as well as their cost-effectiveness. The formal Health Technology Assessment (HTA) report is being compiled by the Department of Health Research (DHR) and would be shared with the National Health Mission (NHM) for updating the national guidelines for sickle-cell anemia,” the company stated on Monday.
