Medical Buyer, Sep 2021: 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 for improving efficiency, early diagnosis and accurate detection.
Polymerase Chain Reaction (PCR)
Molecular tests help in identifying infections at early stages; enabling clinicians with information for personalized and precise treatments. Accurate and early diagnosis prevents transmission and rationalizes antibiotic use.
PCR applies primer mediated enzymatic amplification of DNA to synthesize new strand of DNA complementary to the targeted template strand. Quantitative real-time PCR (qPCR)/ RT PCR is gaining popularity. This technology requires less than 5 hours, is simple, reproducible, and offers a quantitative output.
Isothermal Amplification Methods
Current advancement in qPCRs/ RT PCRs 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 with greater specificity.
Next Generation Sequencing (NGS) Technology
NGS offers broad investigations of the bacterial genomes. It can generate high quality and lower noise background sequence data, is a preferred tool for identification of Single Nucleotide Polymorphisms (SNPs), for detecting mutant strains/ variants.
POCT - Molecular
Diagnostic advancements are further enabling development of systems with cartridges that can be run without stringent clean room requirements while minimizing contamination risks, associated with molecular assays.
Molecular assays based on CRISPR and CAS9 and lateral-flow detection could lead the way and gain market share in the future.
Molecular assays can target multiple gene segments in one reaction. Multiplexing provides several answers to clinicians for identifying the pathogen, and quantitative data 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.
Stringent transportation and storage requirements 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 advanced molecular products.