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Nichols Institute

Division of Quest Diagnostics Inc.

Latest From Nichols Institute

Eyeballing HIV Drug Resistance Testing

Visible Genetics is on track to become the first company to offer a low-cost, rapid, easy-to-use system for clinical diagnostic genotyping using DNA sequencing, starting with HIV drug resistance testing. The company anticipates FDA approval by the end of the year for its HIV GeneKit. Not only does it want to secure a first-mover advantage in HIV resistance testing, but by giving away its DNA sequencer, VGI intends to use this footprint to introduce HCV, HBV and, potentially, cancer diagnostics. And while its sequencing system is not as high throughput as those used in central reference labs, VGI expects to penetrate the market by establishing the capability for decentralized clinical diagnostic technology.ts management team in the past year. Its statements on FDA approval have been as aggressive as its corporate moves.
Medical Device Strategy

A FISH on the Line

Vysis Inc., which is attempting to penetrate the market with its FISH DNA probe technology, got a boost in May when it announced a collaboration with Genentech Inc. to couple the FISH breast cancer test with Genentech's drug, Herceptin. Vysis hopes the deal will showcase FISH technology and attract other drug developers as partners. Genentech, meanwhile, needs such a test to better screen one class of patients to determine their suitability for treatment with Herceptin, in light of controversy over how accurate the existing IHC diagnostic test is in determining their Her2 status.
Medical Device Platform Technologies

Dako Ponders the Expanding Universe

Dako AS, has always been known for its technical acumen and has a strong following in niche laboratory segments, such as immunohistochemistry and in-situ hybridization. But as competition increases, regulations get tighter for research reagents, and customers demand integrated systems, Dako has had to change. It is becoming more focused on clinical products, necessitating major shifts in regulatory and sales and marketing functions, with an aim on achieving global coordination. HercepTest, its first clinical product, is a success, and it hopes to capitalize on a growing interest in pharmacodiagnostics. But it faces tough competition in the systems business from Ventana Medical Systems, a one-time small competitor that now dominates the IHC systems market. Dako is also gambling on a move into flow cytometry.
BioPharmaceutical Medical Device
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Company Information

  • Industry
  • Contract Research, Toxicology Testing-CRO
  • Therapeutic Areas
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Quest Diagnostics Inc.
  • Senior Management
  • George Bragg, Pres. & CEO
    Paul Bellamy, CFO
  • Contact Info
  • Nichols Institute
    Phone: (949) 940-7200
    1311 Calle Batido
    San Juan Capistrano, CA 92673
    USA
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