FDA Authorization for the Next Generation Sequencer - Essay Example

FDA Authorization for the Next Generation SequencerIn 2013, the USFDA granted marketing permits for a genomic sequencer, a technology set to revolutionize the healthcare system (Food and Drug Administration, 2013). Clinical care is expected to provide an individual based care system, based on the study of specific human genomes. In addition, the genomic sequencer is to be applied in Pharmacogenomics by providing patients with specified prescriptions to drugs. Pharmacogenomics is one of the fields yet to be explored in clinical care, and it is likely to enhance the quality of services by increasing the precision of predicting the outcomes of different dosages of drugs.

It is apparent that different people respond differently to different drugs, and the use of genome sequencing will not only reveal the nature and susceptibility of illnesses, but it will also provide physicians with the specific prescriptions required (Collins & Hamburg, 2013). This technology could be used to develop the most appropriate treatment combinations for different patients suffering from cancer. With genomic sequencing, it is possible for doctors to identify the nature of cancer and predict its spreading patterns; hence, the new system will be instrumental in helping doctors deal with different forms of cancer more appropriately (Collins & Hamburg, 2013).

Implementation Policy IssueThe authorization of marketing for the genomic sequencer is a step closer to developing clinical care that is individually oriented. It is; however, clear that some issues like the absence of legal and regulatory policies for the new system will arise (Collins & Hamburg, 2013). There are signs that the authorities are committed to developing the most conducive policies to enable the effective and ethical application of the genomic sequencer. The use of the genomics sequencing technology has the potential to attract ethical issues like insurance companies being acquainted with genomic information about their clients, which could cause the development of exempted services that might be discriminating (Collins & Hamburg, 2013).

Access to genomic information by physicians may also lead to substandard applications of the system. It is required that the development of accurate genomic information must be attained through thorough processes that may require recurrent experimentation (Collins & Hamburg, 2013). The FDA is collaborating with the National Institute for Standards and Technology to design the required interpretive material for physicians. The measure is applied to ensure that patients can discuss with the physicians about their health issues with reference to the genomic information that will be availed through the genomic sequencer.

It is, therefore, crucial that the FDA and the associated organizations develop policies that ensure safety is enhanced with the use of the genomic sequencer (Collins & Hamburg, 2013). RecommendationsThe first step should be ensuring that the application of the genomic sequencer has a set of guidelines that enhance the validity of the information. This should be closely tied with policies that enhance the safety of the system with relation to the development of personalized clinical services.

Patient information should also be safely possessed only by the relevant parties. For instance, insurance companies must only access such information with the consent of the patients to develop an insurance coverage system that suits the health requirements of the individuals. The cost of accessing the system should also be regulated for affordability purposes (NHGRI, 2014).ConclusionThe authorization to market the genomic sequencer is a positive move from the FDA into promoting the development of individual-based clinical care.

The system will possibly solve some of the challenges currently faced by health care providers. The recommended policies should be implemented to ensure legal and regulatory laws are observed in the use of the new system.ReferencesCollins, F.S., & Hamburg, M.A. (2013). First FDA authorization for next generation sequencer. NEJM, 369 (25), 2369-2371. FDA. (2013). FDA allows marketing of four “next generation” gene sequencing devices. Retrieved from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375742.htmNHGRI. (2014).

DNA sequencing costs. Retrieved from: http://www.genome.gov/sequencingcosts/