Diagnostic Kits/Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing

• Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing: A Roadmap to Diagnostics in the 21st Century - This market report provides an important comprehensive view of the history of the diagnostic testing industry. Most of the value for our study lies between page 13-26
  • Important contextual points
    • "Research derived from the Human Genome Project has uncovered significant gene and protein markers of the most prevalent diseases - cancer, diabetes, cardiovascular diseases and others." pages 18-19
    • "Wide dissemination of medical information in the media and on the Internet has spawned a more informed population that are prepared to seek out new technologies." page 19
    • "In the 2000s, developments in molecular biology, disease management research and the unraveling of the human genome will see the scope and direction of lab medicine change significantly." page 23
  • History of the market
    • A trend towards consolidation (all discussed on page 25)
      • "[T]he 1980s and 1990s saw the establishment of some 7000 independent reference labs." page 25
      • "In 2008, there are approximately 3000 small reference labs in the U.S." page 25
      • 1995 Labcorp of America: was formed by the merger of National Health Laboratories and Roche Biomedical Laboratories page 25
      • 1996 3 main players in the market: Labcorp of America, Corning, and SmithKline Beecham (Beckman) page 25
        • 1997 Corning created Quest Diagnostics as an entity to hold their laboratories page 25
        • 1999 Quest Diagnositics purchased the laboratories of SmithKline Beecham page 25
      • Since 1999, LabCorp and Quest have been the two largest independent labs in the U.S.
  • The beginning of patenting
    • "Myriad Genetics, Athena Laboratories (now part of Thermo Fisher) and Nymox Pharmaceuticals were among the first companies to offer their patented and proprietary assays as a service in their own laboratories." page 26
    • The patenting was controversial: The lack of access was "seen as unethical and preventing widespread access to what were considered important tests. Further, both companies pursued labs that infringed on their patent positions by offering these tests and threatened litigation." page 26
    • The report says that the controvery over these patent protects has diminished since then.
  • Table 3.3 "Esoteric and Genomic Service Test Sales, Selected Companies" provides multi-year sales growth information

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