IISc startup PathShodh gets regulatory approvals for COVID-19 Test

PathShodh has received the license to manufacture the test for sale from the CDSCO, after due diligence validation at the Translational Health Science and THSTI, Faridabad, as per the requirements of the ICMR.
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PathShodh Healthcare, a startup incubated at the Society for Innovation and Development (SID) and Indian Institute of Science (IISc), has announced a significant breakthrough in developing a first-of-its-kind, semi-quantitative electrochemical ELISA test for COVID-19 IgM and IgG antibodies.

The startup has received the license to manufacture the test for sale from the Central Drugs Standard Control Organisation (CDSCO), after due diligence validation at the Translational Health Science and Technology Institute (THSTI), Faridabad, as per the requirements of the Indian Council of Medical Research (ICMR). 

According to Vinay Kumar, CEO and co-founder of PathShodh,

“This novel technology can detect COVID-19 antibodies all the way down to the nanomolar concentration. It can work with venous or capillary (finger-prick) whole blood sample as well as serum sample.  We plan to deploy the product in the market in the next couple of weeks. PathShodh’s current production capacity is about one lakh tests per month, and we can scale this up further by augmenting the manufacturing infrastructure.” 

Vinay Kumar, Co-founder and CEO, PathShodh

According to the startup, this test has been developed leveraging PathShodh’s Lab-on-Palm platform “anuPathTM”, which interfaces with disposable test strips functionalized with an immunoreceptor specific to COVID-19 antibodies.

The results are automatically displayed by the handheld reader. Hence there are no subjective errors due to manual readout of test results, as in the current lateral flow assay test kits, claims the startup.

Other features of this technology include on-board memory to store more than one lakh real-time test results, touch screen display, rechargeable battery, Bluetooth connectivity to smartphone and cloud storage, capabilities to map the patient data to Aadhar number and the possibility of connecting test data through APIs to Aarogya Setu.

“The capability to quantify the COVID-19 antibody concentration will be crucial in estimating the declining antibody response over time and hence its possible impact on immunity against recurrence of infection. On a related note, this technique will also play a very big role in elucidating seroconversion response to COVID-19 vaccines, and thereby play a supporting role in vaccination programmes in the future,” says Navakanta Bhat, Dean, Division of Interdisciplinary Sciences and Professor, Centre for Nano Science and Engineering (CeNSE), IISc, who is also the co-founder of PathShodh Healthcare.

The funds for developing and commercialising this technology were provided by the Department of Science and Technology (DST), Government of India, under its initiative on Centre for Augmenting WAR with COVID-19 Health Crisis (CAWACH).

The technology development was also supported by SINE at IIT Bombay and IKP Knowledge Park, Hyderabad. The Society for Innovation and Development (SID) at IISc provided the seed funding for this development.

Edited by Saheli Sen Gupta