Since the human genome was discovered, there has been a push to include genomics in the clinical setting through individualized medicine. This would allow consultants to be more informed about a patient’s needs and potential treatments. It has proven to be difficult, as technology continues to advance. It is also challenging to standardize care processes across departments and facilities.
According to Lazaridis, it would be easiest to incorporate individualized medicine in an established department, since then there would already be a foundation to build upon. In the case of the Mayo Clinic model, an entire new department, or ‘center,’ was created to enable a fully-functioning, enterprise-wide IM Clinic. This includes genome sequencing, bio-banking, bioinformatics infrastructure, information technology, and bioethics resources. The IM Clinic also recruited physicians from multiple departments to have a wider scope and expertise.
The initial offerings from the IM Clinic had two service lines. The first service line is used for patients with advanced cancer who fail standard therapy or where no proven standard therapy exists. These patients must fit specific tumor and life expectancy criteria, since the service line employs comparison of normal and tumor DNA to identify causative or contributing mutations and, subsequently, allows targeted therapy based on genomic information. The second service is tailored for patients with a suspected genetic condition for whom previous genetic testing did not reveal the cause, which is usually referred to as a diagnostic odyssey. This service line uses whole exome sequencing (WES) to reveal the variant(s) responsible for the patient's disease and proposes potential treatments. These initial offerings will hopefully lead to more service lines down the road that contribute to preventative medicine.
Having professional input from a broad group of representatives was important to the success of the IM Clinic becoming integrated into the practice. Consultants were not the only professionals that came from different practices. Representatives from genetic counseling, IT, bioinformatics, bioethics, patient access management, education, revenue cycle, operations and the research sequencing facilities joined the IM Clinic Work Group to design the structures and processes implemented across all Mayo Clinic campuses.
There are still some difficulties within the IM Clinic such as the scalability of genomic counseling, analytics and expert boards, how to expand beyond the initial offerings, how to reduce the turn-around time for clinical WES, and how to move into Whole Genome Sequencing.
The cost of whole genome sequencing is declining globally, while test results become more accurate. Even though the IM Clinic is having the difficulties stated in the previous paragraph, genomic medicine is now being integrated more fully into the enterprise of Mayo Clinic.
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