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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.”

GSK and Abbott Team up For Companion Diagnostic

CEO SUMMARY: Although GlaxoSmithKline PLC is several years away from having a deliverable product from its Antigen Specific Cancer Immunoassay (ASCI) Program, it has a development deal with Abbott Laboratories to produce a companion diagnostic test for ASCI-based products. The in…

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New Lab Player Launches In Breast Cancer Market

CEO SUMMARY: Having opened its CLIA-licensed laboratory in Huntington Beach, California, Agendia, Inc., becomes the newest competitor to enter the market for breast cancer testing. Its proprietary assay looks at 70 genes to assess the risk of recurrence. The company expects to co…

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Lab M&A Deals in June Show Market Direction

CEO SUMMARY: Despite a dismal economy, the month of June spawned two interesting merger/acquisition transactions in the lab testing industry. In one case, a blood brother gobbled up a specialty diagnostics company. In another transaction, two cross-town neighbors in Kansas City m…

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CEO SUMMARY: Biophysical Corporation is creating a new, direct-to-consumer market for laboratory testing. Its unique approach is to offer 250-bioassay test panels—along with a staff physician review of results—to the educated, informed consumer. Testing multiple biomarkers ma…

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Biotech Start-Up Firms Hiring Lab Professionals

CEO SUMMARY: It may be a tough job market right now for laboratory professionals. But investors, lured by the potential of personalized medicine and molecular diagnostics, continue to pour investment capital into new companies. In turn, these companies are actively recruiting exp…

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Why Wall Street Likes Histology Lab Business

CEO SUMMARY: Over the past two decades, investor-owned anatomic pathology companies captured significant market share from community hospital-based pathology groups while delivering profits to their owners. Despite the recent downturn in the economy, Wall Street believes histolog…

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Molecular Advances Soon To Reshape Anatomic Path

CEO SUMMARY: Early this month, the second annual Molecular Summit assembled molecular first movers and early adopters to discuss their efforts to integrate molecular imaging and molecular diagnostics in patient care. One clear message emerged from two days of presentations and di…

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Inaccurate Results + Quest Dominates News Cycle

CEO SUMMARY: Most laboratory professionals don’t know it yet, but significant changes occurred to the entire lab industry last week. After Quest Diagnostics Incorporated acknowledged that it was retesting tens of thousands of patients because 7% of the Vitamin D results it repo…

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December 22, 2008 “Intelligence: Late Breaking Lab News”

Last Thursday, Sunquest Information Systems, Inc. of Tucson, Arizona, announced that it would purchase the “Outreach Advantage Solution” software system developed by Pathology Associates Medical Laborator ies of Spokane, Washington. PAML has spent most of this de…

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A Common Future for Pathology & Radiology?

DO RADIOLOGISTS AND PATHOLOGISTS have a common future in the age of personalized medicine? That’s not an idle question as new technologies help both medical specialties to better understand how molecular processes play a role in various diseases. Oncology may prove to be the powerful force that en…

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