Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing: A Roadmap to Diagnostics in the 21st Century

Test services, once the norm in the diagnostics industry, then abandoned for reagent sales, are now making a comeback.

IVD companies have established cGMP and CLIA-registered labs by which they offer their proprietary tests to physicians, hospitals and reference labs. These tests are outside the oversight of the traditional FDA and CE Mark test commercialization avenue in the U.S, and Europe and so are thought to come to market by what one may seem as the back door.

Kalorama has been watching this trend, and in her unique report, Kalorama Information' s diagnostic analyst Shara Rosen covers the increasing trend in diagnostics towards servicing of tests in addition to selling test kit products and where this fits into the IVD industry today.

• Current market and forecast for diagnostics test services
• Detailed analysis of the esoteric test market (Clinical Chemistry, Immunoassays, Radioimmunoassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry
• Review of Current Products on the Market
• Test Service Revenue Breakdown for Major Companies
• Evaluation of Test Services Products on the Market According to Five Checkponts
• Strategy for Success In Test Service Commercialization.
• Company Profiles

The report covers Clinical test services offered by reference laboratories, hospital laboratory outreach programs, direct to consumer web-based companies, and CLIA-registered company labs. The report describes the lay of the land for test services when they were first launched in the mid 1980s, the status quo in 2008 and a peek into the future.

What are the market factors driving test servicing? What companies are best suited for this strategy now and in the future? What are the best strategies, who has been most successful and where is this trend headed in the future? What are the areas of IVD most likely to be impacted by this trend.? This report answers these questions and more. Rosen' s report will not only describe the market as it is today, but provide a clear picture - a roadmap - to how diagnostics will be practiced in this century.

Shara Rosen is Kalorama' s lead diagnostic analyst and is the author of the Worldwide Market for In Vitro Diagnostics, 6th Edition., Physician Office Lab Markets,Point of Care Diagnostics and several other important diagnostic studies. This study is the result of her research and analysis and interviews with experts in the field.