Molecular diagnostics is becoming one of the dominant platforms in 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 City), 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 now 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 other 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 Sara Agee and Quynh Anh Lu of Singulex Inc. (Alameda, CA) discuss adaptating a life sciences technology to address unmet diagnostic needs. Their article, “Adapting life sciences technologies to IVDs," examines a technology that integrates a microparticle-based sandwich immunoassay format with single-molecule counting instrumentation.

Author Mark Erlander of bioTheranostics Inc. (San Diego) discusses how developing clinically relevant genomic classifiers will continue to be longer than anticipated. His article, Realizing the postgenomic promise in oncology testing, explores the reasons including greater-than-expected disease complexity, longer-than-expected time to clinical validation, and regulatory hurdles.

Authors Roger Peck, Bernhard Weigl, Jose Jeronimo, and John Sellors of PATH (Seattle) review current screening technologies and consider what is needed for determining risk of developing cervical cancer in women in low-resource settings. Their article, “Human papillomavirus testing today and tomorrow,” examines such tools that hold the promise of implementing successful screening programs in lower tiers of the healthcare system.

For the In Person interview, IVD Technology spoke with Walter H. Koch, PhD, head of research for Roche Molecular Diagnostics (Pleasanton, CA). In this interview, Koch discusses what the IVD industry is doing to help make the envisioned future of personalized medicine standard clinical practice.