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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.”

Systems Approach For Pre-Authorization Of Genetic Tests

CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there …

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Pre-authorization Coming For Pricey Molecular Tests

CEO SUMMARY: In response to the steep ramp-up in the utilization of genetic and molecular testing, the nation’s largest health insurers are preparing to institute new guidelines for coverage and reimbursement. These will include pre-authorization by physicians, a more effective genetic …

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Preparing for New Lab Role In Personalized Medicine

CEO SUMMARY: Laboratory medicine is about to find itself between the two jaws of a powerful vise. One jaw is pending major legislative overhaul of the entire healthcare system, along with dwindling reimbursement as Medicare and Medicaid runs out of money. The other jaw is personalized med…

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Two New Pathology Models Will Soon Be Tried in Dallas

CEO SUMMARY: There are notable aspects to how and why four unlikely partners are banding together to invest $40 million and create the nation’s newest reference and esoteric testing laboratory. It was the pathologists at Baylor University Hospital in Dallas, Texas, who originated the vi…

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Baylor Pathologists Form Lab with US Oncology

CEO SUMMARY: In Dallas, Pathologists Bio-Medical Laboratories is part of a new laboratory partnership that includes Baylor Health Care System, Texas Oncology, and US Oncology. The four partners ponied up a total of $40 million in cash and debt to build a state-of-the art laboratory in a 1…

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Oncologists Cut Into Pathologists’ Revenue Pie

EVENTS NOW UNFOLDING IN DALLAS, TEXAS, SIGNAL A DIFFERENT DIRECTION for pathology and clinical laboratory testing. As you will read on pages 3-9, in May, just weeks from now, a new laboratory company, funded with $40 million from an unlikely combination of four partners, is about to become operationa…

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February 15, 2010 “Intelligence: Late Breaking Lab News”

In response to the sky-rocketing expenses associated with genetic and molecular testing, health insurers are planning ways to control both utilization and the prices at which these tests are reimbursed. For example, during the past year, Humana began using DNA Direct …

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Pathology, Inc. Sells Equity to Raise Capital

CEO SUMMARY: In looking how to propel its business to the next level, the partners at Pathology, Inc., opted not to sell their pathology group practice. Instead, they chose to raise capital by selling equity in their company to a group of investors. In this exclusive interview, executives…

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Two Big Pathology Groups Tap Investors for Capital

CEO SUMMARY: Pathology supergroups in California and Tennessee have each announced major recapitalizations. Both groups will use some of the money to cash out retiring partners. The balance of the new capital will be used to expand their businesses. With so many baby boomer pathologists a…

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Physicians in Survey Recognize Lack of Genetic Test Knowledge

MOST PHYSICIANS BELIEVE they are inadequately informed about pharmacogenomics (PGx) and how to utilize genetic tests. That’s the finding of a survey of 10,303 physicians and reveals an opportunity for pathologists and clinical lab professionals to fill an unmet need. In fact, only 10% of the 10,30…

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