Vinay Kumar lived in a remote village in western UP where the health facilities were not up to the mark. He was diagnosed with a chronic condition called juvenile diabetes at the age of 14 when his mother noticed that he was losing weight. He was required to take daily insulin injections to manage his illness. But there was no doctor or testing facility in his village. The only doctor available was two-and a-half hours away from his village. No one in his family had even heard about juvenile diabetes until that point.
Similar to Vinay, millions of people suffer from diabetes and 1.6 million deaths are attributed directly to the chronic disease each year globally. It causes serious health issues, including blindness, foot amputations, heart attacks, chronic anaemia and kidney failures. Doctor advised Vinay to leave school but it was his mother who was determined to get her son good education. Vinay’s childhood experiences taught him the importance of science and motivated him to pursue research in public health and chronic disease diagnostics — including diabetes, kidney failure,anaemia and protein deficiencies. He went on to do his MSc from Kurukshetra University and later completed his PhD from Indian Institute of Science (IISc), Bengaluru.
It was in Bengaluru that he got the idea to eventually set up PathShodh Healthcare — a company incubated at the Centre for Nano Science and Engineering (CeNSE) at the prestigious IISc. Their bio-sensing device which can measure multiple parameters related to diabetes, chronic kidney disease and anaemia and malnutrition or protein deficiencies is called AnuPath. This on-thespot test does not need special storage conditions or sample/reagent preparation and is ultra-low cost — 80% cheaper than conventional testing methods. The technology makes it simple to do some of the important tests related to diabetes and Chronic Kidney Disease. The test is done by simply collecting blood/urine sample and putting it onto the strips, removing all intermediate steps. Also, the technology makes these tests very quick; it requires only one minute for each test. The technology is based on dry test strip and not on any enzymatic or immunoassay-based technology, thus making it very robust to changes in temperature and humidity.
The high-tech and high-quality device has met International Electrotechnical Commission (IEC) and European safety standards. Anupath has already been used to screen lakhs of people in India. And now, in response to the ongoing pandemic, PathShodh Healthcare has made a significant breakthrough in developing a first-of-its-kind, semiquantitative electrochemical ELISA test for COVID-19 IgM and IgG antibodies. PathShodh has received the icense to manufacture the test for sale from the Central Drugs Standard Control Organisation (CDSCO), after due 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 1 lakh tests per month, and we can scale this up further by augmenting the manufacturing infrastructure.
” The novelty of the technology lies in 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 on to the ACE2 receptors on the host cells before infection. Hence, antibody tests targeting the S1 spike protein are more representative of immune response against infection compared to those that target the Nucleocapsid (N) protein. 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.
This test has been developed by leveraging PathShodh’s Lab-on-Palm platform AnuPath, which interfaces with disposable test strips functionalised with an immunoreceptor specific to COVID-19 antibodies. The results are automatically displayed by the handheld reader. Therefore, there are no subjective errors due to manual readout of test results, as in the current lateral flow assay test kits. The other unique features of this technology include on-board memory to store more than 1 lakh real-time test results, touch screen display, rechargeable battery, Bluetooth connectivity to smart phone 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 very crucial in estimating the temporal decay of antibodies, and hence its possible impact on immunity against recurrence of infection. 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 programs in future,” said Prof. Navakanta Bhat, co-founder of PathShodh Healthcare, who is also the Dean, Division of Interdisciplinary Sciences, and Professor, Centre for Nano Science and Engineering, IISc.
The test kit comes in two parts. One is the handheld analyser which reads the blood sample and gives a detailed report. The other is a test strip where a drop of blood from one’s fingertip is inserted into the device. The handheld device provides the results within five minutes, the results of which can be downloaded on a mobile phone.
“The test is not only useful as a routine sero-survey tool to establish a previous infection, but even more importantly, as a quantifier of antibodies to address such critical questions as the rate of fading of antibodies, and in general, understanding of biological responses that depend on the quantity of antibodies, such as the efficacy of vaccines in generating antibodies and vaccine breakthroughs,” said Prof Ashutosh Sharma, Secretary, DST.
