Originally Published IVD Technology November/December 2005
EDITOR'S PAGE
Coming to fruition
Molecular diagnostics is the wave of the future in the IVD industry—still. Analysts and market reports support this view by projecting that the annual growth rate in molecular diagnostics will be 15–20% during the next three to five years. According to Kalorama Information (New York City), molecular diagnostics will be one of the fastest-growing segments in the IVD market.
Such high expectations for molecular diagnostics are nothing new. When the Human Genome Project was completed in 2000, IVD manufacturers expected a flurry of activity and an explosion of growth in molecular diagnostics. One area in particular that manufacturers anticipated would take off was personalized medicine. However, the hoped-for growth in molecular diagnostics has yet to come to fruition. Even though the molecular diagnostics market has been increasing steadily during the past few years, it has not achieved the massive growth that manufacturers had expected.
Recent developments during the past year suggest that molecular diagnostics may finally be on the verge of explosive growth. FDA issued a final guidance on pharmacogenomic data submissions, followed by a preliminary concept paper on drug-diagnostic codevelopment. By releasing these documents, FDA has demonstrated its support for advances in personalized medicine. Besides pharmacogenomics, other factors may contribute to future growth in molecular diagnostics. In this issue's Commentary, Hank Nordhoff, chairman, president, and chief executive officer of Gen-Probe Inc. (San Diego), discusses such growth opportunities in molecular diagnostics ("Realizing the Potential of Molecular Diagnostics,").
In addition to examining growth opportunities, Nordhoff discusses potential challenges to the growth of molecular diagnostics. One challenge involves the impact of patient acceptance and demand on molecular diagnostics. Even though the public does not know a lot about molecular diagnostics, it is becoming more exposed to them. For example, retail pharmacies are selling tests purporting to be genetic tests, which claim to provide personalized nutrition and health assessments based on an individual's genetic profile.
With such alleged genetic tests being made available directly to consumers, they could cause confusion and even disillusionment about molecular diagnostics among patients. IVD manufacturers need to ensure that the public receives the correct information about molecular diagnostics. In a previous editorial (March 2005), we urged the IVD industry to launch a public awareness campaign to demonstrate the value of IVDs. The need for such a campaign has become more urgent with greater public exposure to molecular diagnostics. Before any misinformation or misunderstanding jeopardizes the growth potential of molecular diagnostics, IVD manufacturers should make every effort to ensure that the right information gets out.
This could be a defining moment for IVD manufacturers, a time when they could take advantage of changing market and regulatory conditions, and give molecular diagnostics the boost needed to reach the growth levels they have been expecting. The question is to what extent are manufacturers willing to contribute to and help out their own cause.
Copyright ©2005 IVD Technology
