View from India: PoC diagnostics represent a challenge and an opportunity

Point of care (PoC) diagnostics is not new to India. It’s been around in the form of glucometers, ECG and personalised devices. The fact that PoC is cost effective and offers clinical information about patients immediately has made it popular.

Conventional lab testing has also been around for a while. Centralised lab testing is again more cost effective if there are many people to be tested. However, where it involves only a single person, PoC home testing is preferable.

Covid has altered our outlook with its thrust on ‘contactless.’ Wherever possible, people tried to look for a contactless approach in many situations. So, coming to Covid, whether people were infected or not, they insisted on monitoring their health on their own and preferably within the closed doors of their home.

Another lesson from Covid is the speed in which clearance approvals of medicines had to be done for emergency use. Licenses had to be certified quickly, then distributed sites required support. The user experience needs to be factored in. All this had to percolate to everyone in the economic pyramid.

“Different technologies have to be developed for point-of-care labs for tier cities. This could meet requirements such as quick diagnostics for taking clinical decisions. The process could be systematised by maintaining e-healthcare records,” said Dr Chandrasekhar Nair, chief technology officer, Molbio Diagnostics, speaking at a webinar organised by the Infosys Science Foundation (ISF) in collaboration with the IIT Alumni Centre, Bangalore.  

The Covid-led skepticism has spurred entrepreneurs to look at point-of-care technology (POCT). This is where further challenges and opportunities lie.

“Many issues related to the supply chain became more obvious during Covid. Antibody tests required some sort of innovation. This could happen through an interdisciplinary work involving nanotechnology and AI-ML backed by institutional support. New delivery models from disease centres to home care have come up,” said Prof Navakanta Bhat, dean, division of interdisciplinary sciences, and a professor at the Centre for Nano Science and Engineering (CeNSE) at the Indian Institute of Science (IISc).  

Covid also created an opportunity for PathShodh Healthcare, a start-up nurtured by the Society for Innovation and Development (SID) at the IISc. The start-up has developed the first of its kind, semi-quantitative electrochemical 'ELISA' test for Covid-19 IgM and IgG antibodies.

PathShodh Healthcare, co-founded by Prof Bhat, has received the license to manufacture for sale from the Central Drugs Standard Control Organisation (CDSCO), after validation at Translational Health Science and Technology Institute (THSTI), Faridabad, as per the requirements of Indian Council of Medical Research (ICMR). Prof Bhat is credited for arriving at a PoC diagnostics called ‘anuPath.’ This 'lab-on-palm' platform for diabetes, anaemia and malnutrition, kidney and liver disease was repurposed for a Covid-19 rapid antibody test.

When researcher start-ups focus on point of care (PoC) diagnostics, they need to ensure that the end product can be translated for public use. Funds need to come in to make it work. Tech could be an enabler here. The PoC diagnostics need to be sensor-driven, easy to hold like a handheld device and connect through apps. The design may include portability and accessibility. A prototype could be built with a user interface and this prototype may be deployable and scalable to lower costs. It could also prove a daunting task to take it to the international market. At that stage, aspects such as volume manufacturing crop up. Essentially, manufacturing technologies require reliable and scalable prototypes.

PoC diagnostics also includes biodegradables. What then comes to mind is whether it is generating plastic waste. The environmental impact of the product should be low. Even better if we could have a portfolio of energy-saving lightweight devices for specific tests. The global chip shortage is another hurdle here. It may be that one can work from the backend and build a chip-manufacturing ecosystem. With this, naturally, comes regulatory issues. Regulatory agencies could work with developers to bring in solutions in healthcare for the country. This may help in shrinking the go-to-market time, as well as lowering the cost of device.

A deep tech ecosystem may help build vendor support. In the case of clinical trials, if there are new platform technologies from ideation to reality then it may be necessary to incorporate it into the system. While working on PoC diagnostics, it could be worthwhile to create a device that enables independent care, and which remains low-cost and low on maintenance. Testing could be done through PoC diagnostics and deployed at third party location. Scalability, cost and manufacturing are all linked to the ecosystem.

“Around two decades ago, there were insufficient diagnostics, which then lead to glucose sensing. It was a challenge to translate designs into products, have the freedom to operate and sell them, and keep pace with the competitive products,” recalled Dr Nair. Early learnings told Nair that for a PCR to work, it had to have a platform at point of care and allow directed therapy to follow for patients to recover. To evoke a fast reaction was a challenge. “We came up with a chip to run the temperature quickly. Then we developed electronics and optics to pick up signals, which was followed by a device to be deployed on field,” added Nair. PCR (polymerase chain reaction)-based testing enables direct testing of genes (human or of infectious agents) from patient samples.   

Supply chain, regulatory measures and government policies are among the challenges. “Healthcare requires affordable diagnostics, which is an innovation-science-technology driven business. The journey can be traced from academic research to commercialisation at scale. Then what does it require to take-to-market? A confluence of different fields along with technology may help to find out the gaps in the market,” said Dr Dhananjaya Dendukuri, CEO and co-founder, Achira Labs Pvt Ltd, a medical diagnostics company that develops and commercialises innovative technologies for PoC medical testing.  

Generally speaking, innovation has been nurtured in labs, encouraged through mentorship and sponsorship programmes. Perhaps it’s time to now path to scale, find funding for marketing, and provide support for 10,000 consumables. All this could generate value for the product and attract investments. These may be the green shoots in building bridges in the VC (venture capitalist) ecosystem. VCs tend to look for products that may rake in money. Entrepreneurs need to address the risk-to-market issues.