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personalized medicine
Personalized medicine or PM is a medical model that proposes the customization of healthcare, with medical decisions, practices, and/or products being tailored to the individual patient. In this model, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient’s genetic content or other molecular or cellular analysis.
The use of genetic information has played a major role in certain aspects of PM. and the term was first coined in the context of genetics, though it has since broadened to encompass all sorts of personalization measures.
Personalized medicine is not limited to pharmaceutical therapy. Advances in computational power and medical imaging are paving the way for personalized medical treatments that consider a patient’s genetic, anatomical and physiological characteristics.
Several terms, including “precision medicine,” “targeted medicine” and “pharmacogenomics” are sometimes used interchangeably with “personalized medicine.”
According to the FDA, the term is often described as providing ‘the right patient with the right drug at the right dose at the right time.’ More broadly, PM may be thought of as the tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up.
Advances in genetic and molecular knowledge about different diseases are widely expected to generate more opportunities for PM products and services. Clinical laboratories and pathology groups are continually developing new capabilities in molecular diagnostics, such as the analysis of DNA, RNA, and the human proteome.
Reimbursement policies will have to be redefined to fit the changes that PM will bring to the healthcare system. Some of the factors that will be considered are the level of efficacy of various genetic tests in the general population, cost-effectiveness relative to benefits, how to deal with payment systems for extremely rare conditions, and how to redefine the insurance concept of “shared risk” to incorporate the effect of the newer concept of “individual risk factors.”
New MoPath Lab Coalition Takes its Case to Congress
CEO SUMMARY: Prices recently established for molecular diagnostic tests are so low that they put patient access in jeopardy, declared a new lab industry coalition in a statement delivered to members of Congress. Called the Coalition to Strengthen the Future of Molecular Diagnosti…
New Lab Industry Trends Require Responses by Labs
CEO SUMMARY: One stark difference between the presentations delivered at last year’s Executive War College and this year’s presentations in New Orleans last week was near-unanimous recognition that the era of fee-for-service payment is soon to end! Speaker after speaker urged the…
Benchmarking with the Best To Be a World Class Laboratory
CEO SUMMARY: This fourth installment of this special series about the laboratory value pyramid introduces “Level Four: Use Benchmarks to Achieve Best-in-Class.” This is the highest level of the four level pyramid. When a lab organization performs at this level, it will be deliver…
Defining a Path to Clinical Laboratory Best-in-Class via Benchmarks
CEO SUMMARY: With the American healthcare system undergoing a major transformation, it is essential that all clinical laboratories and pathology groups recognize this transformation and effect the right strategies to meet the needs of physicians, patients, and payers. A g…
Pathology Consolidation Underway in Washington
CEO SUMMARY: Two regional pathology super-practices have emerged in Washington State. In each case, acquisitions and mergers are fueling the growth of the two large pathology groups. In Western Washington and the Seattle metro, CellNetix is the dominant pathology group, with 53 physicians…
New Pricing Formula for Advanced Diagnostic Tests
CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diagnostic tests (ADTs) and directs CMS to assign a temporary HCPCS code and use list prices to pay labs for such tests …
Whole Genome Sequencing Is Poised for Clinical Use
CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …
Claritas Is Example of New Lab Business Model
CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts…
December 23, 2013 “Intelligence: Late Breaking Lab News”
Saudi Arabia is the second country to embark on the goal of sequencing 100,000 human genomes. Earlier this month, the Saudi Human Genome Program was announced. Funding for the program, expected to take five years, will be provided by the Saudi Arabian national science agency. The fir…
November 11, 2013 “Intelligence: Late Breaking Lab News”
Who would have guessed that Angelina Jolie would do a multi-million-dollar favor to Myriad Genetics, Inc.? Jolie caused quite a stir earlier this year when she went public with the news that she had done a prophylactic double mastectomy after she had learned the results of her BRCA test for br…
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