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Molecular diagnostics in pandemics-A key role player

World unceasingly encounters the challenges to deal with the progressively emerging unprecedented life threatening infectious diseases. Occasionally these infections turn into major outbreaks in their origin places and later on to pandemic.

PreCOVID-19, India were already dealing with dengue, chikungunya, malaria, and novel 2009 H1N1 and were major challenges for healthcare authority during seasonal outbreak. Since end of the year 2019 SARS-Cov-2 (COVID-19) risen as a new challenge. Healthcare system crucially depend upon the laboratory diagnostics system and molecular diagnostic play a crucial role right from genetic testing, personalized cancer therapy to right antibiotic treatment for life threatening microbial infections.

Global market has created mixed opportunities for the molecular diagnostics in all segments such as manufacturers, suppliers, and service providers. According to a market report, estimated USD 10.85 billion in 2019 and USD 15 billion revenue generation anticipated in 2020, which majorly influenced due to COVID-19 pandemic demand.

Currently molecular based COVID-19 testing evolving as rapid, efficient, and promised quality diagnostic results. Many biomedical companies are providing the solution for COVID-19 testing from high yield specimen collection to highly sensitive and accurate results reporting. However, the various diagnostics techniques have their limitation in term of false positive and false negative results, specifically in early stages of disease infections.

US FDA has granted emergency use authorization to several molecular based commercially available kits for diagnosis of COVID-19 to boost up the fight against this pandemic. In India, diagnostics laboratories are using both EUA and ICMR approved kits depending on their availability in market.

A major segment of molecular diagnostics market is claimed by manual as well as semi-automated platform offering promised results. Several new kits manufactures are now being offering the COVID-19 RT-PCR kits and nucleic acid purification kits at affordable cost. Make in India campaign initiated by government is also encouraging a significant number of manufactures to fulfill the current demand to fight against the pandemic.

As per the most recent evidence given by the CDC and WHO, the route of transmission for SARS-CoV-2 in human-to-human, by large aerosol droplets and contaminated hand and surfaces. Diagnostic laboratory work that include PCR analysis and processing of clinical specimens from patients who are suspected or confirmed to be infected with the virus responsible for COVID-19, are required to be conducted under controlled environment i.e. BSL-2, 3 practices and good laboratory procedure that again pinpoints toward ethical and regulatory requirements. Requirements of these kind of controlled systems create an opportunity for engineering companies providing the solution for controlled inward airflow systems.

To increase the testing capacity, high throughput automated molecular based systems are being made available by companies for the commercial purposes that can perform more than 5000 tests in a day. Multiple installation of this kind of high throughput automated systems can lift the testing capacity manifolds.

Nowadays point-of-care (PoC) testing are successfully creating space in diagnostic industry, that would increase the scope of speedy and scalable diagnosis for the community out site the erudite laboratory setup with potential of obtaining an evaluation in shortest time to take appropriate action towards patient treatment and disease management. It would also have added a helpful step towards the clinical trials and in vaccines development at every phase.

In spite of limited availability of therapeutic drugs option, specific disease targets for disease management is another challenge for the clinicians. Inconceivable efforts are being made by worldwide healthcare service providers to contain a global crisis by aggressive testing with maximum capacity to flatten the curve of COVID-19. 

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