Molecular Diagnostics: The Time is Now

How often do you hear the term RT PCR in your daily conversations with friends and families? You may say almost every day. But if asked that when did this jargon enter our day-to-day talks, I am sure we can all point our fingers to one event – the Covid-19 global pandemic.

The ongoing pandemic has fueled the access and awareness of RT PCR to an unimaginable extent. To put things in perspective, the number of RT PCR machines already installed in India before the pandemic was roughly 400, and now – post-pandemic – it is approximately 2500. If we see it through the lens of behaviour, the awareness of RT PCR was hardly any. It was too esoteric a term to be a part of routine diagnostics and was confined more to academics or research. But today, RT PCR dominates the parlance of not only the medical fraternity but also of the common people like you and me.

What really is Molecular Diagnostics?

Molecular diagnostics (MDx) is a collection of techniques used in the process of identifying a disease by studying molecules, such as proteins, DNA, and RNA, in tissue or fluid. MDx involves the application of molecular biology techniques to study human diseases, including infectious diseases, inherited conditions, as well as cancers.

MDx has expanded medical genomics in a major way. Molecular assays complement results obtained from routine serology, microbiology, and hematology tests by identifying disease biomarkers, creating sensitive diagnostic assays and ultimately finding new treatments and potential cures.

Coming to RT PCR (Real-Time Polymerase Chain Reaction), it is one of the many techniques that make up MDx and works by combining reverse transcription of RNA into DNA (for RNA-based pathogens) and amplification of specific DNA targets using polymerase chain reaction. In short, RT PCR is a nuclear-derived method for detecting the presence of specific genetic material in any pathogen: bacteria, fungus, virus, or a parasite.  Other platforms under MDx include NGS (Next-Generation Sequencing), Sanger Sequencing, and Microarray.

Why do we need more Molecular Diagnostics?

All you read so far was about MDx and RT PCR and their applications. It’s time we move to the other side of the story. To begin with, let’s take a look at sepsis.

Sepsis is clinically defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. In simplified words, it’s a systemic disease caused by a pathogenic infection leading to multi-organ involvement. To highlight the gravity of this condition, in India, every 3 minutes a patient dies due to a septic shock. Sepsis accounts for 63% of neonatal deaths and other populations at risk include immunocompromised patients, patients who have undergone organ transplants, or patients in ICUs to name a few.

Conventional diagnostics come with their own limitations. Routinely used blood culture methods are not an ideal gold standard, as the results often come too late, are incomplete or not sensitive enough, and can be misleading and relatively labor-intensive.

And that’s when RT PCR comes into the picture. The areas in which RT PCR, or any other molecular diagnostic platform test, wins over a routine pathology test are reduced TATs (Turn around Times) and high accuracy. MDx tests are known to produce results in times as short as three hours, have high multiplexing capacity that allows identification of exact pathogens leading to targeted treatments, and enable rapid detection of pathogens from micro-volume blood samples.

And Sepsis is just one such example. Similar challenges are encountered in the diagnosis of hospital infections, oncology, gastroenterology, or neurology diseases, all of which have a significant contribution to India’s disease burden, and MDx is increasingly becoming the go-to diagnosis decision tool for superior clinical outcomes.

Why the time is NOW?

In case the name multiplexing didn’t make it clear to you before, multiplex RT PCR involves amplifying multiple DNA or RNA targets in a single PCR reaction. While RT PCR addresses the drawbacks of conventional testing by offering reduced TATs and higher accuracies, it is the multiplexing ability that has revolutionized the potential of diagnostics in disease management. This power of multiplexing has triggered innovation – locally and globally – to develop comprehensive test panels. At the forefront of innovation in MDx is research and development on harnessing the multiplexing ability in the areas of home care and point of care as well.

No doubt there is a long way to go, but the time is ripe. Pre-covid penetration of MDx in western countries was close to 15% whereas that in India was a meagre 3%. In light of the heightened awareness, accessibility, and affordability, physicians now have better choices that inevitably lead to improved patient outcomes. The current context has shown us what the future in-patient care will look like and embracing molecular diagnostics will place India on the global map of high standards in-patient care.

– Shyamakant Giri, CEO, Rivaara Labs