Growth of In-Situ Hybridization Testing Exceeds Other Technologies

In situ hybridization tests (ISH), which are probes for specific DNA sequences performed on portions of tumor tissue, have become one of the fastest growing market segments in laboratory medicine, showing 8% sales growth per year, according to a recent market report.

With new enhancements the technology will continue to drive revenues for Abbott Laboratories (Abbott Park, IL, USA), Genzyme (Cambridge, MA, USA), Nitrogen (Carlsbad, CA, USA), and a host of other test makers, according to a report from healthcare market research publisher Kalorama Information (New York, NY, USA). The report noted that ISH has performed better than other technologies that were predicted to dominate the industry.

"ISH is carving out a growing market share because of its usefulness for a variety of cancer markers including ER [estrogen receptor], PSA [prostate-specific antigen], EGFR [epidermal growth factor receptor], and Her-2 [human epidermal growth factor receptor 2],” said Shara Rosen, senior diagnostic analyst for Kalorama Information. "It has outperformed expectations made for it in the last decade and shown more growth so far than other celebrated areas such as microarrays and DNA assays.”

The world market for all ISH (silver, chromomeric, or fluorescent) is estimated by Kalorama Information to be US$670 million in 2009. Vendor sales are comprised mostly of individual antibodies or probes and instrumentation to automate the staining and reading of slides, along with digital imaging systems and data analysis software in high-end systems. It is these systems, which offer automated sample preparation and digital analysis instrumentation that Kalorama Information believes will continue to put ISH in a leadership position, allowing for same-day biopsy results and better patient care.

"The technology is moving from manual and operator-read to automated and digitally interpreted,” said Ms. Rosen. "ISH testing used to be qualitative and inherently subjective; resulting in significant deficiencies in the interpretation of test results, but automation has made it more relevant.”

The new automation has also allowed some movement of histology from hospital and reference laboratories to large physician practices in the United States. Digital imaging can convert entire microscope slides into high-resolution digital slides. Therefore, digitized images of an entire slide can be analyzed, stored, and remotely viewed on computer monitors located anywhere. This digital capability sets the stage for pathology telemedicine and small bench top systems for small labs and physician office laboratories as well as labs in rural areas, according to Kalorama.

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