Next Generation Sequencing Provides Responsiveness for Identifying Resistant Pathogens

According to a new market analysis, next generation sequencing (NGS) may impact the infectious diseases IVD sector by bypassing some of the downside of PCR-based testing, as NGS can provide more flexibility and responsiveness in identification of new pathogenic strains.

NGS may earn its place in clinical testing as its use in labs is well-timed with the growing need for responsiveness in the area of antimicrobial resistance and pathogen typing, according to Kalorama Information (New York, NY, USA). When strains change their makeup, molecular tests often can't keep up while sequencing remains flexible. Adaptability is a problem with standard approaches. Primer and probe selection for molecular assays is a well-developed process, but such assays lack adaptability once set in place for routine use. The fluid genetics of particularly virulent and antimicrobial-resistant strains and clones are at times capable of escaping the specificity of selected probes and primers.

"Specificity is molecular diagnostics' major strength, but is also a weakness when assay development isn't caught up with microbial adaptation," said Emil Salazar, Kalorama Information analyst, "NGS can overcome this limitation with the flexibility to detect any number of genetic variants."

Company and market information and other trends regarding NGS and healthcare-acquired infections (HAIs) are available through Kalorama’s reports: “Next Generation Sequencing (NGS) Markets 2015 (Systems, Consumables, Services, Acquisitions, Agreements, Competitive Analysis, Platforms, Applications, Brand Ownership and Other Trends)” and “Healthcare Associated Infection (HAI) Control Markets (Disinfection, Area, Sterilization, Device Sterilization, Testing-C.diff, Testing-MRSA, Treatments).”

Established assay forms such as real-time PCR (qPCR) are able to overcome narrow analytical scope through multiplexed panels, particularly beneficial in the case of critical infections, providing positive identification with shorter turnaround. Nevertheless, labs still point to drawbacks of larger panels that may include higher test product prices and undesirable selection of targets.

NGS will not fully replace, and even has yet to compete well with, common molecular diagnostics such as PCR, which remains effective. However, the specificity of PCR makes it less suitable for clinical epidemiology and personalized medicine – two significant areas of health spending growth, particularly due to the unfortunate challenge of healthcare-acquired infections (HAIs). Multiplexed HAI assay kits currently remain largely unavailable for the clinical market, most are available only as laboratory developed tests (LDTs) or testing services without premarket approval or other clearance processes.

With NGS, the onus is shifted considerably from hypothesis-driven diagnosis to the interpretation of more data-rich results. In the case of infectious disease testing, the risk is considerable as it surpasses individual outcomes and could impact public health, justifying careful deliberation by regulators.

Kalorama’s report comprehensively analyzes research and clinical markets for NGS as well as transformative iterations of the technology already edging into "third-generation sequencing" territory.

Related Links:
Kalorama Information
Next Generation Sequencing (NGS) Markets 2015, report
Healthcare Associated Infection (HAI) Control Markets, report