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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.”
June 4, 2012 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XIX No. 8 – June 4, 2012 Issue
It’s a milestone on the path to personalized medicine and an example of how integrated health informatics will give clinicians real-time access to unlimited amounts of medical data. The 1000 Genomes Project announced in recent months that “the world’s largest set of data on hum…
Top 10 IT Trends Send Message For Labs & Pathology Groups
By Robert Michel | From the Volume XIX No. 6 – April 23, 2012 Issue
CEO SUMMARY: Healthcare’s shift away from fee-for-service medicine and toward integrated clinical care is widely recognized. However, few lab administrators and pathologists are aware of the even faster transformation underway in healthcare informatics. Presented here are the “Top 10 …
MedTox, Cleveland Clinic Labs, Apollo PACS, Dell, British Columbia Health
By Robert Michel | From the Volume XIX No. 3 – February 20, 2012 Issue
GENOME SEQUENCING TO BE OFFERED BY NORWAY IN NATIONAL HEALTH PLAN HERE’S A MILESTONE ON THE PATH TO PERSONALIZED MEDICINE. Norway is the first nation to announce that its national health system will incorporate whole genome sequencing. Cancer is the target of Norway’s f…
Personalized Medicine: Meet Pathologists’ New Competitors
By Robert Michel | From the Volume XIX No. 2 – January 30, 2012 Issue
IF THERE IS ANY SINGLE “NEXT BIG THING” that will truly revolutionize healthcare, it is likely to be personalized medicine. This approach promises to deliver improved outcomes to individual patients, while helping to control—or even reduce—the cost of care. Central to personalized medicine w…
Pick Your Medicine: Personalized or Precision?
By R. Lewis Dark | From the Volume XIX No. 2 – January 30, 2012 Issue
DURING THE PERSONALIZED MEDICINE WORLD CONFERENCE (PMWC) that took place in Silicon Valley last week, there was much excitement about the earliest clinical services that meet the definition of personalized medicine. It won’t surprise pathologists and lab administrators to learn that companion diag…
Medicare Carrier Plans to Reject Molecular Claims
By Robert Michel | From the Volume XVIII No. 15 – November 7, 2011 Issue
CEO SUMMARY: In September, Palmetto, a Medicare carrier serving California and seven other states, made public two draft local coverage determinations (LCDs) that revamp its coverage guidelines for molecular diagnostic tests (MDT) and laboratory-developed tests (LDT). All labs su…
How Digital Pathology Helps Pathologists Deliver Added Value
By Robert Michel | From the Volume XVIII No. 12 – September 6, 2011 Issue
“Pathologists have the opportunity to take on a new clinical role as the integrator of all that digital pathology information, in combination with the patient’s other clinical data collected from a wide variety of sources.” —Dirk G. Soenksen, M.S., M.B.A., Founder…
Why Canada Has Growing Shortage of Pathologists
By Robert Michel | From the Volume XXVIII No. 11 – August 15, 2011 Issue
CEO SUMMARY: In Canada, it is known that the supply of pathologists and laboratory physicians has diminished since 1998. Further, a federal program that measures patient wait times for certain surgical and imaging procedures does not measure how long patients wait for ana…
“Primary-Care Pathology” One Goal at Beth Israel
By Robert Michel | From the Volume XVII No. 15 – October 25, 2010 Issue
CEO SUMMARY: In a pioneering collaboration, the pathology department at Beth Israel Deaconess Medical Center in Boston, Massachusetts, will work with GenomeQuest, Inc., to perform whole genome sequencing of tumor specimens. GenomeQuest will handle sequencing, assembly, and annota…
Many Questions About FDA Regulation of LDTs
By Robert Michel | From the Volume XVII No. 14 – October 4, 2010 Issue
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprie…
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Volume XXXII, No. 6 – April 21, 2025
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