BENGALURU: An IISc (Indian Institute of Science) startup PathShodh Healthcare has made headway with its testing method for antibodies by receiving approvals to go ahead for production. The method is said to give a more precise quantative information on the pathogens present in one's body.
PathShodh 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), said a note by IISc on Tuesday.
The technique is different from the usual antibody tests available in the market which are based on the ELISA technique.
The test method checks the electrochemical oxidation and reduction (redox) activity of the two antibodies IgM and IgG that are produced in response to the Glycoprotein (S1), a SARS-CoV-2 Spike.
Researchers believe that the S1 spike protein targetted test are more representative of the immune reponse to the infection in comparison to tests targetting the Nucleocapsid (N) protein.
"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," said 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, in
a note.
He also said that the technique will play a significant role in explaining the seroconversion (development of antibodies in the blood serum as a result of infection or immunization) response to COVID-19
vaccines, and thereby play a supporting role in vaccination programmes in the future.
In addition to this, the results of the test are visible on the handheld reader instead of manual readout of the results, thereby eliminating errors. The testing device can also store more than a lakh results in real time, is rechargeable and has bluetooth connectivity to smartphone and cloud storage. It can also connect the data of the patient to his or her Adhaar card number. This is possible tby leveraging the startup's already existent technology anuPathTM, a lab-on-palm platform which can diagnose and manage of diabetes, liver
disease, anaemia and malnutrition at an early stage.
"It (the technology) 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 1 lakh tests per month, and we can scale this up further by augmenting the manufacturing infrastructure,” said Vinay Kumar, CEO and co-founder of PathShodh.