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What is molecular medicine?

In 1953, Watson and Crick described the beautiful double helical structure of DNA – the genetic code that guides all life. Eleven days shy of the 50th anniversary of this Nobel prize-winning achievement, the completion of the sequencing of the human genome was announced.

Instantly, we moved from the pre-genomic to the genomic era of medicine. This is also known today as molecular medicine.

There are many examples of how our understanding of disease, including cancer, infectious disease, autoimmune disease, cardiovascular disease and more, has been magnified by exploring molecular mechanisms at the DNA, RNA and protein levels.

These are the molecules that carry on the “business of life” and it is becoming increasingly clear how when they “go wrong” they carry on the “business of disease.” Molecular medicine applies this knowledge to more effectively identify and treat these problems.

What does it mean for health care?

The best current examples of molecular medicine exist in laboratory medicine—that branch of medicine concerned with examination of body fluids and tissues in order to establish a diagnosis. (Some call the pathologist, the physician involved in diagnostic examination of fluids and tissues, the “doctor’s doctor.”) Pathology and laboratory medicine are mainstays of the clinical “workup” of a patient.

Over the decades, many branches of pathology have evolved to deal with different conditions. Blood may be examined for protein factors to diagnose a clot, red blood cell number to diagnose anemia, white blood cell number to diagnose leukemia, cholesterol and other lipids for cardiovascular disease risk; there are literally hundreds more examples.

In the 1980s, scientists discovered that certain questions about disease could be answered by examining a patient’s DNA and RNA. The DNA of blood and bone marrow could be examined to identify key markers of leukemia or lymphoma. Blood cell DNA could be examined for genetic mutations indicative of sickle cell anemia.

These were examples of the new field of molecular diagnostics; many of the first tests in the field were for diseases of the blood, since blood is such a readily accessible tissue. In time, we learned how to test solid tissue for DNA changes associated with solid tumors and bodily fluids for specific infectious diseases, for example urine for Chlamydia and plasma for HIV.

Molecular diagnostics grew in the ‘90s and into this century. At the same time, great scientific progress led to the sequencing of the complete human genome. An age of molecular medicine where science had now deciphered the blueprint of life was able to take full advantage of the maturing field of DNA and RNA diagnostics, also referred to as molecular diagnostics.

How can this work impact treatment and outcomes?

A prime example of molecular diagnostics meeting personalized therapies includes the diagnosis and treatment of a particular form of leukemia.

In chronic myelogenous leukemia (CML), a highly specific change at the DNA level triggers and sustains the disease. Molecular pathologists have been able to diagnose that specific molecular change since the early ‘90s. In time, the Swiss pharmaceutical company, Novartis, developed a drug called Gleevec that worked to shut down this process. The molecular change pathologists had been diagnosing for years led to a medication designed to defeat that particular molecular change; this is a case of molecular diagnostics meeting tailored treatment of a tumor—a prime example of the benefits of molecular medicine.

What is personalized medicine?

Personalized medicine takes into account that each of us is different, particularly when it comes to our DNA and the way each of us may respond differently to similar treatments for the same disease.

One of the missions of CMM is to facilitate the physician-directed use of personalized medicine for effective, tailored treatments of patients.

Personalized medicine depends upon molecular analysis, that is, laboratory tests that analyze a patient’s DNA, RNA and/or protein patterns. Medicine is concerned with management of a patient’s disease or predisposition to disease. Personalized medicine takes the goal of optimal management one step further by choosing approaches most likely to be successful in the context of a patient’s genetic and environmental profile.

What is Pharmacogenomics?

Pharmacogenomics, or PGx, is the response to therapeutic drugs by an individual as a function of that individual’s genetic makeup.

Given that our genes define every characteristic of a person, to a greater or lesser extent and depending on environmental factors, it’s actually not surprising to consider that our genetics influence our ability to respond or not respond to drugs. Just as allergic reaction to ragweed pollen is genetically determined (it bothers some and not others), so too is the ability or inability to metabolize a drug. Thus, a particular drug may prove effective in one individual while the same drug causes a severe adverse effect in a second.

The Center for Molecular Medicine employs FDA-approved technology called DNA microarrays to assess an individual’s genetic makeup. Based on the results of these tests (for a gene family called CYP450) a patient’s physician gains the ability to prescribe in a tailored, specific fashion, the right drug at the right dose perfectly suited to that individual, thereby maximizing the chances that the drug therapy will be successful. The era of “trial and error” prescription is drawing to a close. CYP450 testing enables the right drug at the right dose, the first time and every time.

Will the CMM offer its services directly to patients?

The CMM was established as a resource for physicians and researchers. Any patient testing done at the CMM must be requested by a physician.