PoC molecular diagnostics

In today’s era of medical exigency, there is an increased need for accurate and faster molecular diagnostic methods. Advances in miniaturization, nanotechnology, and microfluidics, along with developments in cloud-connected technologies are enabling a remarkable makeover in the field of molecular diagnosis via point-of-care (PoC) molecular diagnostics. PoC devices are pushing the frontiers of low-cost, user-friendly, rapid, and enhanced-sensitivity molecular-level diagnostics. The combination of various bio-sensing platforms within smartphone-integrated electronic readers provides accurate on-site and on-time diagnostics, based on various types of chemical and biological targets. Further, 3D printing technology shows a huge potential toward fabrication and improving the performance of PoC devices. Integration of skin-like flexible sensors with wireless communication technology creates a unique opportunity for continuous, real-time monitoring of patients for both preventative healthcare and during disease outbreaks.

The PoC devices enable physicians to improve the standard of care by combining quick diagnosis with treatment decision in the first visit by the patient instead of hours and days to have the test results. This would help prescribe a treatment in the first instance without having to wait for final results.
In addition, improving knowledge in the understanding of molecular mechanisms in the common as well as rare disorders, and the advancement of DNA sequencing and analysis, are some other factors that are expected to enhance PoC molecular diagnostics capabilities.

For instance, the use of mutation-specific targeted analysis, using comparatively more portable sequence analysis platforms for the diagnosis of ‘single gene’ ailments and extremely parallel next-gen sequencing, enables simultaneous multi-gene examination, which can be used to sequence exomes for direct clinical testing. These are the types of developments that can improve the current way of molecular diagnosis into a more robust and rapid technology.

Over the last decade, healthcare industry has focused its attention and development effort in the enhancement of two key aspects of molecular diagnostics, such as moving toward prevention and early detection rather than finding a cure, enhancing portable testing capabilities.

The global PoC molecular diagnostics market was valued at USD 1.72 billion in 2018 and was anticipated to grow at a CAGR of 13.2 percent from 2019 to 2027 to reach USD 2.39 billion by 2027. The top companies operating in PoC molecular diagnostics market are Alere Inc., Quidel Corporations, F-Hoffmann-La Roche Ltd., Danaher Corporation, Thermo Fischer Scientific, Meridian Bioscience Inc., Mesa Biotech Inc., GeneSTAT Molecular Diagnostics, and Biocartis Group NV. PoC in molecular diagnostics has numerous applications, including near-patient testing in infectious disease management, oncology, hematology, prenatal testing, and endocrinology. Moreover, it has been observed that a sizeable revenue flow is progressively being directed toward areas focused on diagnostic capabilities and PoC diagnostics. During the course of the next decade, a significant number of product commercialization and new product development cycles are expected to take place that will reinforce the molecular diagnostics gaining high rate of growth. The ongoing R&D, future product commercialization, PoC application and usage, market adoption, penetration rates, and revenue flow for these products are expected to contribute in the development and growth of the market. However, the question arises–What takes time in commercialization of PoC molecular diagnostics? The most appropriate answer is the amount of research behind it in the form of development of method, its translation into the product, and subsequent clinical trials before making the product enter into the industry-scale production and market availability. Overall, PoC diagnostics have aced and will breed more in near future.