Molecular Diagnostics picks up pace

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Molecular diagnostics (MDx) is witnessing a fast-paced growth for detection of infectious micro-organisms as well as ailments like oncology. Laboratories are relying on MDx as a powerful tool for improving efficiency, with early diagnosis and accurate detection.

 

Molecular tests help in identifying infections or ailments at early stages; enabling clinicians with information for personalized and precise treatments. Accurate and early diagnosis prevents further transmission, and rationalizes antibiotic use, thereby minimizes chances for antibiotic resistance.

 

Polymerase Chain Reaction (PCR)

PCR applies primer mediated enzymatic amplification of DNA to synthesize new strand of DNA complementary to the targeted template strand. Of late, quantitative real-time PCR (qPCR) is gaining popularity for detection of pathogens. This technology requires less than 5 hours, is simple, reproducible, and offers a quantitative output.

 

Isothermal Amplification Methods

Current advancement in PCRs and development of novel enzymes has led to the adoption of isothermal amplification methods, including loop-mediated isothermal amplification (LAMP) and polymerase spiral reaction (PSR). LAMP is a unique nucleic acid amplification technique that amplifies few copies of DNA into billion copies within an hour under isothermal conditions (constant temperature) with greater specificity.

 

Next Generation Sequencing (NGS) Technology

NGS offers broad investigations of the bacterial genomes and can be readily applied in clinical microbiology. NGS can generate high quality and lower noise background sequence data, is therefore a preferred tool, for identification of Single Nucleotide Polymorphisms (SNPs), for detecting mutant strains.


POCT - Molecular

Diagnostic advancements are further enabling development of systems with cartridges that can be run without stringent clean room requirements while minimizing risks related to contamination, generally associated with molecular assays.

Molecular immune-assays based on CRISPR and CAS9 and lateral-flow detection could lead the way and gain good market share in the near future.

 

The advantage

Molecular assays can target multiple gene segments in one reaction. Multiplexing provides several answers to clinicians for identifying the pathogen, and quantitative data provided helps in therapeutic drug monitoring. Industries find it easy to scale molecular assays, as oligosaccharides, enzymes and probes are readily available and once optimized, menu expansion is easy too.

 

Stringent transportation and storage requirements for molecular assays often make these tests less accessible and affordable for laboratories in rural areas. However, more and more companies are building capabilities to lyophilize reagents to mitigate these challenges.

 

To conclude, Indian diagnostic companies are geared up to match MNCs for developing more versatile and advanced molecular products customized for local settings.

 

Dr. Manoj Chugh

Associate Vice President – R&D

Transasia Bio-Medicals Ltd. 



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