Molecular Assays

The field of molecular assays, molecular testing or molecular diagnostics is one that has shown promise as a renewing instrument of technological progress in the clinical laboratory and improved patient care in medicine. While the term “molecular diagnostics,” in its broadest sense, can be applied to clinical chemistry or immunoassay with equal validity—both technologies analyze molecular species—it has been reserved for use with technology and techniques that identify and/or quantitate genetic materials (DNA, RNA).

A better nomenclature might be “nucleic acid diagnostics” or “genetic diagnostics.” Indeed, in some instances, “nucleic acid diagnostics” has been used to refer to this technology. The term “molecular diagnostics,” however, has become the standard terminology that describes a technology dealing solely with the array of nucleotide sequences called gene and their expression and/or identifying presence in the determination of pathological states.

To many, molecular diagnostics offers an opportunity for the revival of what has been, for many years, a “less than stellar” diagnostics industry. Over the past 20 to 25 years, clinical diagnostics companies have presented the market with technology that has been little more than a reworking of older products and methods. A few substantive new tests have emerged over that period and alternative analytical technologies, such as bio- and chemiluminescent systems, have made key inroads in the clinical laboratory market. By and large, however, these have not been break-point technologies, that is, they have not revolutionized or replaced existing technology and converted markets.