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Molecular diagnostics is becoming one of the dominant platforms of clinical laboratory medicine, representing one of the fastest growing segments in the IVD industry. It has emerged fully from research into clinical practice. According to Kalorama Information (New York), the molecular diagnostics market totaled $3.21 billion in revenues in 2007. The market is expected to reach $5.42 billion by 2012 with an estimated annual growth rate of 11%.

Molecular diagnostics instrumentation automates many of the sample preparation and assay steps that were formerly labor intensive, and new tests are continually being launched. Many molecular tests are CE-marked and FDA-cleared, and many more are being developed. Consequently, molecular testing is indicated in many areas of healthcare, including cardiology, oncology, infectious diseases, inherited diseases, and disorders.

However, the contribution that such tests can make to patient outcomes still faces significant barriers including reimbursement issues, lack of standardization across test platforms, limited quality-control products and programs, and the inability to fully interpret test data.

Taking into account such trends, this issue discusses some of the latest technology developments in molecular diagnostics.

Authors Jonathan Siegrist, Régis Peytavi, Michel Bergeron, and Marc Madou discuss how, in order to design a sample-to-answer system for nucleic acid IVDs, the desired system’s specifications and characteristics must be established. Their article, “Microfluidics for IVD Analysis: Triumphs and Hurdles of Centrifugal Platforms,” (page 27) defines the fundamental steps required in a sample-to-answer nucleic acid system, with an emphasis on sample preparation and a description of the technologies involved.

Authors Benjamin L. Miller and Randolph R. Henke of Lighthouse Biosciences Inc. (Rochester, NY) discuss some key technological advances in molecular diagnostics and the government and societal demands that are leading to increased adoption of this science in clinical laboratories. Their article, “Developing the Use of DNA in Rapid and Multiplexed Detection Schemes,” (page 35) highlights some early-stage technologies that could accelerate the adoption of molecular diagnostics in clinical laboratories and eventually in decentralized formats.

For the In Person interview, IVD Technology spoke with Alice Jacobs, MD, founder, chair, and CEO of IntelligentMDx (Cambridge, MA). In this piece, Jacobs talks about trends and technological developments in molecular diagnostics, their value in battling drug-resistant pathogens and assessing the health of organ-transplant patients, and more. Be sure to check out the extended version of this interview online at ivdtechnology.com.

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