Molecular Testing in Your Lab? What You Need to Know to Make the Decision

May 1, 2009 | Evaluations & Guidance


Healthcare-related genetic research is hot. Researchers routinely announce the results of various studies linking specific genes or genetic variants to diseases or conditions such as diabetes, obesity, and cancer.

Bridging the gap between these new findings and improvements in patient care is molecular testing, one of the fastest-growing areas of laboratory testing—and one that has started moving from research settings to the clinical laboratory. Among other advantages, molecular tests can often return results more quickly and with greater sensitivity compared to traditional, non-molecular-based diagnostic tests.

You may be thinking about adding molecular testing to your facility’s laboratory services. However, this can be a serious undertaking, and before you get started, you’ll need to know what questions you need to ask in the process. You’ll also need to know what special preparations are necessary to accommodate molecular testing compared to traditional testing. This article provides a starter set of considerations to get you thinking about these and other topics so that your molecular testing program—if you choose to implement one—gets off on the right foot.

The term molecular testingas frequently used in clinical diagnostic testing today describes testing that analyzes deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) at the gene, chromosome, or genome level to identify the source of a disease or identify factors that affect disease susceptibility or progression. Once the underlying factors are identified, physicians can use this knowledge to improve diagnosis and provide more effective treatment.

Molecular tests are used for a variety of applications. For example, molecular tests, like traditional tests, can be used for identifying the presence of...

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