Point-of-Care testing is defined as the clinical testing performed at or near the site where clinical care is being given to the patient. It can be performed by patients itself or any personnel. Consecutively, analyzing the DNA and finding out the best treatment option based on the genetic makeup of the patient constitute Point-of-Care genetic testing.
This is a fast and quick technique based on personal genomics so to allow the efficient functioning of the drug. The idea behind this point-of-care genetic testing approach is to reduce the diagnosis time, inconvenience faced by patients and to follow personalized medicine approach for specific patient.
Generally, all the diseases are combination of various genetic factors, and current genetic testing techniques require a lot of time in analyzing the problem. As a result, the use of Point-of Care genetic testing systems is prevalent in quickly diagnosing and guiding the doctors to head in a right direction.
Point-of-Care Genetic testing involves amplification of genetic material and then real-time analysis to detect the genetic variations among people. The first point-of-care version of a real-time nucleic acid detection system is the Cepheid’s Xpert system, going to be launched this year.
It combines fully integrated sample preparation for amplification and detection process. This system is designed to purify, concentrate, detect, and recognize targeted nucleic acid sequences delivering diagnosis using unprocessed samples approximately within 30 minutes.
The point-of-care genetic testing technology possesses convenient and immediate action for a therapeutic condition. The growth is likely to continue with the aim of providing less costly and closer to patients care. The use of genetics has become prominent nowadays in almost every pediatric condition, and this technology overcomes the limitations and challenges of current molecular testing techniques.
Pressure on healthcare budgets and the trend to patient-centered care might be perceived as problems confined to the developed world. Moreover, the increase in population and westernization in the developing countries like China and India links it with the increase in the healthcare problems.
Due to poverty and lack of sources, Point-of-Care genetic testing technology has a major scope in these countries by providing diagnostics available at low prices and at patient’s bedside.
There are some technological limitations like failure to detect abnormal results, standardization, technological expertise, algorithmic & software complications, higher cost of maintenance & repair, poor tests result in case of contaminated samples, and sample specificity in the use of point-of-care genetic testing systems.
In addition, the high cost of Point-of-Care genetic test and limited reimbursement support is hindering the growth of point-of-care genetic testing market.
A global trends of making healthcare service more patient-centeric than the service provider shows an expanding growing opportunities for point-of-care genetic testing, as there are lots of funding available from multiple sources including NIH, US Department of Defence as well as various private foundations and biopharmaceutical companies. The point-of-care genetic testing market includes various types of testing includes diabetes, hematology, oncology, infectious disease, and others indications.
Point-of-Care genetic testing is going beyond the laboratory, as FDA granted its first CLIA waiver to a nucleic acid based test. The Alere I Influenza A&B and cobas Liat System and Strep A from Roche have received a CLIA waiver in 2015.
In the cardiovascular domain, Spartan Biosciences received the approval from Health Care Canada for their Spartan RX CYP2C19 system in 2014, a genetic test that can be used to govern whether patients receiving the antiplatelet medication clopidigrel (Plavix) following percutaneous coronary intervention (PCI) have CYP2C19 mutations that may weaken their ability to metabolize the drug.
Based on geography, the point-of-care genetic testing market is segmented into North America, Latin America, Western Europe, Eastern Europe, APEJ, Japan and Middle & Africa. Sustained implementation of point-of-care genetic testing requires that new technologies address the need of targeted settings. The combined power of microfluidics and smartphone technologies will be going to boost the market of point-of-care molecular testing.
The US is recognized at the top country in the sector of Point-of-Care genetic testing market because of technological advancement, awareness among the population and high per capita income. In Europe, Germany is also recognized as the market player in this industry.
Asia-Pacific is expected witness significant growth rate in the coming years due to increasing investment in cancer research, increasing awareness and funding by government to curb the prevalence of infectious diseases and active participation of corporates in the healthcare technologies.
Cepheid, IQuum, Biocartis, Abbott, Idaho Technologies, ThermoFisher, Roche, Optigene, Lumora are some of the global key players in point-of-care genetic testing. In 2016, Biocartis Idylla’s distribution rights were also granted to Thermofisher in the US.
The Idylla platform is a fully integrated system enabling laboratories to perform a broad range of applications in oncology and beyond. But in 2014, Iquum’s Liat Analyzers’ rights were acquired by Roche Molecular Diagnostics.
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