“Diagnostics solutions in the infectious disease domain are not available to the needy population”
There are some diseases which are of national importance - HIV being first. We have rapid kits which are good such as Tridot. Then we have good immunoassay CD4, CD8 which are available in semi point of care (POC) format, and then the reference labs and hospitals use flow cytometry or Molecular Dx for accurate diagnosis in labs. Here, the sample is blood which makes it so easy for sample collection and diagnosis. HIV is an exception as there was a very concerted, sustainable effort.
However, for other diseases like TB, an accurate point of care test is the need of the hour. However sample collection itself is a challenge. We have good molecular and culture tests suitable for a medium to a large lab setting. TruNat gives that additional advantage of peripheral setting usage but throughput is very less. Hence upfront investment is high. That’s why there is a need for a solution - where sample collection is easy, throughput is also good and can be adopted in POC settings.
Diagnostic solutions in the infectious disease domain except for SARS-CoV-2 in the Indian scenario are not available to the needy population. There is a dearth of quality serology and/or molecular diagnostics-based tests except a few imported but not cost-effective solutions in the Indian context for e.g., GeneXpert cartridge-based test for TB, ID Now by Abbott for COVID-19.
Before the implementation of the new medical device rule (MD-2017) by the Central Drug Standard Control Organization (CDSCO), only notified test/devices (HIV, Hep-B, Hep-C and blood grouping antigen) were regulated in India, hence most non-notified IVD kits and reagents lacked the required quality standard.
After the implementation of MD-2017, Indian manufacturers have improved their quality system and CDSCO have helped with the notifications issued from time to time to provide clarity on the manufacturing process and quality standards. There is a need to fast track regulatory approvals to service the gap of accurate, accessible and economical infectious disease diagnostic solutions
Also, for better industry-academia collaboration, there needs to be greater visibility into areas of research being pursued by institutions. The industry will rapidly adopt and even scale up once they see the clinical and commercial benefit. Institutions can collaborate with the industry at early stages, with a very clear orientation towards making a clinically acceptable product.
A fair economical model can be also put in place which fosters transparent and attractive partnership. Institutions are flushed with high tech capability, they use it for basic research and for publications. Often such research is lab focused and proof of science. We need to take it further from proof of concept to a viable product.
There are examples of Academia and Industry having participated in offering new solutions to market both pre and post COVID. MD Check (Feluda) developed by Delhi-based Institute of Genomics and Integrative Biology (IGIB), commercialized by Tata Medical & Diagnostics is one such case. An early-stage collaboration between Academia and Industry would improve efficiency in ensuring that proof of concept graduates to a market required solution backed with clinical validation and quality standards.