INDIA – Bengaluru-based ShanMukha Innovations has developed an indigenous diagnostic kit for Sickle-Cell Anemia, SickleCert, designed to be a direct aid in clinical decision making.

SickleCert is a newly developed diagnostic assay that will enable clinicians to rapidly distinguish between sickle cell disease and sickle cell trait.

Currently ongoing clinical trials, it is an easy-to-use confirmatory test that is comparable to the gold standard HPLC test.

The recent development comes after the Central Drugs Standard Control Organisation approved the manufacturing license for SickleCert kits for ShanMukha Innovations as a Class C in-vitro diagnostic medical device in November 2022.

ShanMukha Innovations is a health-tech startup incubated by the Society for Innovation and Development (SID) at the Indian Institute of Science (IISc) in Bangalore.

It is a spin-off from the Indian Institute of Science, Bangalore that is on a mission to bring the diagnostic lab to the samples to serve the healthcare needs of billions of people worldwide.

In addition to its SickleCert, the IISc-incubated startup has introduced a screening test kit called SickleFind and a portable analyzer, HaemoCube.

SickleFind is a newly developed diagnostic assay that can be used for the rapid screening of individuals with sickle cell disease and sickle cell trait.

The kit is currently being tested in clinical trials and it has been found to perform better than the commonly used solubility test.

ShanMukha Innovations said that its indigenous diagnostic tests are powered using an advanced technology called High-Performance Optical Spectroscopy (HPOS) for accurate diagnosis.

“The technology has been licensed to a spin-off from IISc, ShanMukha Innovations Private Limited for commercialization,” IISc-incubated Shanmukha Innovations said in a statement.

A companion smartphone application enables digital data recording, analysis, and integration with different registries such as Ayushman Bharat Health Account (ABHA) and other cloud-based patient health record systems, the company claimed.

In addition to diagnostic prowess, the point-of-care test provides an affordable and efficient solution to screen large populations as it generates highly accurate results in 15 minutes.

The mobile health solution aligns with India’s ambitious goal dubbed the National Sickle Cell Elimination Mission to eradicate the disease from the country by 2047.

The Indian government has set aside adequate funds to facilitate the screening for Sickle-Cell Anaemia targeting approximately 1 million individuals living in affected tribal areas over the next 3 years.

Through smart mobile labs, connected instruments, and novel kits integrated with a digital platform, ShanMukha Innovations has expanded its diagnostic product portfolio.

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