IISc start-up PathShodh gets regulatory approvals for Covid-19 test

PathShodh Healthcare, a start-up incubated at the Society for Innovation and Development (SID) at Indian Institute of Science (IISc) has developed a semi-quantitative electrochemical Elisa test for Covid-19 IgM and IgG antibodies. PathShodh has received the license from the Central Drugs Standard Control Organisation (CDSCO) to manufacture the test for sale, IISc said in a press release.

PathShodh’s technique, which is protected through US and Indian patent applications, is also a major departure from the qualitative rapid antibody tests in the market, which are primarily based on the lateral flow Elisa technique, the press release added.

The technique will play a big role in elucidating sero-conversion response to Covid-19 vaccines, and thereby play a supporting role in vaccination programmes, said Navakanta Bhat, dean at the Division of Interdisciplinary Sciences at IISc.

The technology can detect Covid-19 antibodies all the way down to the nano-molar concentration. It can work with venous or capillary (finger-prick) whole blood sample as well as serum sample, PathShodh chief executive Vinay Kumar said, adding they plan to deploy the product in the market in the next couple of weeks. The startup’s current production capacity is about one lakh tests per month, and it said it can scale this up further.

The novelty of the technology, the IISc release said, is based on the measurement of electrochemical redox activity of IgM and IgG antibodies specific to the SARS-CoV-2 Spike Glycoprotein (S1). The S1 protein has a Receptor Binding Domain (RBD) which latches onto the ACE2 receptors on the host cells before infection. Hence, antibody tests targeting the S1 spike protein are more representative of the immune response against infection compared to those that target the Nucleocapsid (N) protein.