Medical Device Link.

Having moved successfully from research into clinical practice, molecular diagnostics is one of the fastest-growing segments of the diagnostics market, according to analysts at Kalorama Information (New York City). For its recent Who’s Doing What in Molecular Diagnostics report, published in April, Kalorama Information partnered with Emmes Group Inc. (Boston) to assemble and analyze data from the Emmes 2008 Molecular Tests Database. The database contains data collected from 1000 interviews with laboratory professionals, including staff from 830 hospital labs, 32 public health labs, and 130 reference labs.

The molecular testing industry has seen many developments since the mapping of the human genome. Predicted increased market penetration of molecular assays over the next few years will be the result of both maturation of the technology and the development of appropriate diagnostic applications, according to Kalorama. The commercialization of rapid, user-friendly, economical, high-quality testing systems will launch these assays farther into the market, as will the discovery of molecular-based therapeutics that will allow for more individualization of disease management.

Molecular testing is now indicated in many areas of healthcare, including cardiology, oncology, infectious diseases, inherited diseases, and chronic disorders. Some molecular tests are regulated by FDA; others are developed by labs. Instrumentation automates many of the sample-preparation and assay steps that were formerly done by hand. Most molecular labs have more than one real-time system, such as the Roche Light Cycler, the ABI 7500, or the Roche TaqMan 48. They may also use systems marketed by Cepheid, BD/GeneOhm, Gen-Probe, Siemens, and Third Wave. Large labs tend to house one main analyzer that performs high-volume tests for infectious diseases; other analyzers are used for such specific tests as HIV, thrombophilia genes, hepatitis, and oncology markers.

Molecular tests, first introduced in the late 1980s, have made the greatest market gains in the area of testing for infectious diseases. In 2008, infectious-disease tests still make up the largest segment of the market. Kalorama Information expects the infectious-disease tests to maintain their market position for at least the next half-decade thanks to advances in viral-load testing for HIV and hepatitis and “increased research in microorganism pathogenicity related to molecular variation.”