COVID-19 and its effect on future molecular diagnostics

Over the last 20 years, there has been a gradual shift in the emphasis of basic biomedical research from the study of disease in patients and their organs to its definition at the level of molecules and cells. This new trend has been underpinned by a remarkable new technology, which has made it possible to isolate and sequence genes, study their function, and transfer them across the species barrier. In the short time, during which this field has evolved, a great deal has been discovered about human pathology at the molecular level. Many monogenic diseases have been characterized, much has been learnt about the molecular and cell biology of cancer, and a start has been made in defining different genes that comprise the complex interactions between nature and nurture that underlie many of the major causes of mortality like cancers, cardiovascular disorders, and lifestyle diseases.

It is important, therefore, that medical practice prepares itself for the remarkable possibilities that the rapidly moving sciences of molecular and cell biology will have to offer it in the future. This has particular implications for medical education; specialists in the field will have to be able to communicate with those working in the basic sciences so that their technology can be adapted most effectively for the benefit of the health of communities.

COVID-19 has demonstrated how important it is to have access to fast, reliable tests. Getting swift results not just for COVID-19 but also for various other medical conditions is a primary need.

There is also a requirement to adopt a more analytical approach toward gathering health data to monitor public health and establish trends. All this is possible only through digital means and advanced technologies like machine learning, AI, IoT, etc. With a more aware and knowledgeable generation, we know there will be a demand for greater access to such data-driven approach even in the healthcare industry.

As per a WHO study, diagnostics comprise around 5 percent of hospital costs, but contribute 60–70 percent of healthcare decision-making. India has one of the lowest spend on diagnostics in the world.

The pandemic taught us for self-reliance on Indian R&D for kits as well as instruments as the logistics and ancillaries from other countries got a hit. From two-three kits and instruments for molecular testing in March 2020, today we have more than 30 kits being made in India for COVID testing and more than 1500 labs that do testing from a handful at the beginning of the pandemic. The diagnostic industry needs to be prepared for testing in a manner that will allow the sourcing of critical raw material ramping up the numbers at a short notice. Manufacturers of diagnostic kits and material need to strengthen and expand their facilities, and even enhance supply chain and make it agile enough to cope with sudden demands, and speed up the mitigating response to a crisis.

Efficient logistics is an important aspect that defines success in the diagnostic industry, and a well-connected logistics and supply chain will be the most significant difference between this pandemic and the next.

India is a land full of opportunities for players in the medical device industry. The country has become one of the leading destinations for high-end diagnostic services with tremendous capital investment for advanced diagnostic facilities. The kits/instruments manufactured in India can also help other nations to ramp up their diagnostics with low input costs.

Molecular diagnostics is one of the fastest-growing pathology sectors. The infrastructure created initially for COVID now can have applications for genetic testing, infectious diseases testing, blood screening, oncology testing, cardiovascular testing and others, especially if the cost of reagents is brought down with manufacturing the same in India rather than importing from outside.

There is no question that COVID-19 has propelled rapid technology advancement and rapid regulatory approval of technologies, such as wearables, POC diagnostics, and digital health. We need these factors to continue beyond COVID-19 and foster the emergence of more essential healthcare solutions, governed by a regulatory establishment that welcomes and supports continuous innovation.