Technological Advancements in Molecular Diagnostics: Current Scenario & Way Forward

By Srikanth
8 Min Read
Technological Advancements in Molecular Diagnostics

The first step to high quality healthcare and effective disease management is accurate diagnostics, which is the essential basic requirement for medical experts to determine a disease or disorder and offer the requisite course of treatment which could involve further tests, medication, surgery and follow-up. Providing better preventive healthcare solutions and better patient care, affordability and accessibility depends on these key factors. 

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Current scenario of India’s molecular diagnostics arena

India’s pathology and diagnostic technology industry saw a consistent phenomenal growth in the last 20 years, and given the current Covid-19 pandemic scenario, it showed a tremendous leap. From a $9 billion market in 2018, it jumped from a 6% growth overall to 20-25%. Digital and technological innovations are now integral to this industry, supported by its national health policies and programs which aim to make affordable healthcare accessible for all sections of society, including the rural population.

Free Diagnostic Service Initiative (FDI) launched in 2015 under the aegis of the National Health Mission (NHM) government of India to provide accessible and essential quality diagnostics in lab pathology and radiology fields at all public health centers, led to the compilation of a National Essential Diagnostics List (NEDL) in 2019 – a bouquet of the required basic and essential diagnostic tests drawn up bearing in mind the region-wise healthcare priorities. India became the first ever country to implement this initiative. This resulted in a proper assessment of the country’s disease burden, disease trends and effective collation of data, and extensive emphasis on research.

The Covid-19 pandemic has positively impacted the level of health awareness, and the need for quality preventive healthcare and health insurance. The demand and potential for upgraded equipment got a huge boost with the awareness for implementing the latest software applications and newer testing methods which require shorter turnaround time, while stressing on increased accuracy in testing.

To cope with the need of the hour, the Govt. spruced up their efforts to provide incentives for growth in the domestic medical devices industry and encouraged FDI (Foreign Direct Investment), in order to achieve a leading rank in the medical devices manufacturing industry. Furthermore, marketing communication techniques showed a huge improvement as well – e.g. health tracking applications, online consultation, awareness of diagnostic tests and health insurance services – thus boosting the demand for preventive and curative healthcare.

New Age Diagnostic Technology: Robotic Process Automation

In view of the ongoing Covid-19 pandemic scenario, robotic process automation has emerged as a logical solution at high-end diagnostic centers, along with digitization to cover the lacunae in the area of skilled lab technicians and personnel, as well as improved precision and quicker results.

“Robotic automation can complement human effort, not substitute for it.” Thus, the concept of Cobots (collaborative robots which are smaller, lighter and safer than industrial robots) is a more appropriate viable solution as an assistive tool in lab automation, thereby leading to better staff deployment. Cobots can undertake the more time-consuming, repetitive and relatively risky tasks like sample bar-coding, sorting and separation of vacutainers, preparing stains and smear slides, bottling, de-capping, re-capping, centrifugation of samples,  etc.), thereby encouraging a paradigm shift in these processes to move from manual processing to automated processing.

Adopting cloud based robotics and artificial intelligence (AI) will considerably cut down on human intervention in the areas of sample collection, sample and reagent handling, sample analysis,  and diagnosis. It can further lead to seamless data organization, collation and management, for overall efficiency, precision, accuracy, quality control, and minimized error in reporting.

The need of the hour is to emphasize on AI-based analytic solutions which would automatically lead to the generation of a larger volume of tests, as it can help with faster turnaround time (TAT), thereby making it cost-effective too. AI would support a much higher level of safety standards as well, by reducing human exposure to biohazards, better inventory management, and hugely improved patient services overall.

Implementing automotive processing is economically sustainable in the long run, as it leads to reduced operation costs and minimizes the chance of human error, thereby clearing the path in meeting the pre-set global standards in the field. Synchronization of Laboratory Information Management Systems (LIMS) with automated processing will greatly enhance overall performance.

However, there is an acute lack of AI trained personnel, which poses a considerable challenge to the molecular diagnostics industry currently. On the other hand, it also holds great promise and potential  in the  field of AI personnel training .

Way forward

Molecular diagnosis has become an important tool for the diagnosis and management, especially in the case of infective as well as non-infective conditions.

The Covid-19 pandemic exposed a plethora of problems, shortcomings and weaknesses of molecular testing in the labs. It brought into sharp focus, the lacunae in the field of molecular diagnosis and the lack of proper and acquirable equipment and its easy availability, which further revealed the inability to increase the reagent capacity at the earliest. Many labs lacked the proper lab environment and there was considerable difficulty in acquiring the personal protection kit.

While on the one hand, there has been a rapid advancement in the manufacturing of molecular equipment and reagents, on the other hand, non-Covid research and diagnosis has taken a back seat. Most of the molecular testing is focusing on the identification of viruses and their variants.

However, this pandemic has had many beneficial effects too: RT-PCR instrumentation and the capacity to produce the reagents in large volumes has been seen during this episode. This can now be used in the diagnosis of non-Covid and non-infectious conditions.

The lessons leant from the covid pandemic in the field of Molecular Medicine has shown that the diagnostic tests and reagents can be fabricated in a short time. Not only that, we have seen that the instrumentation can be simpler, easily available and user and lab-friendly. Many such equipments do not now require the stringent structural changes needed in the laboratory. Hence, using the technique of molecular diagnostics is possible in smaller and mid-size laboratories, bringing this technology closer to the common man.

The costs of molecular diagnosis and the turnaround time has also been reduced and hence, post- Covid, it has become easy to diagnose some complex infections within a smaller period of time, with lesser false negatives and false positives.

In short, the Covid-19 pandemic has brought great advancements in the field of molecular diagnosis and also made it easily available to the common man.

By Dr. Angeli Misra, Consultant Pathologist and Director, Lifeline Laboratory

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