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Pregnancy Support

Areas of Interest
We are interested in study submissions involving:
  • Harmony prental test*
  • Preeclampsia
    • Comparison of protein biomarkers to clinical products
    • Biomarker values in healthy individuals
    • Health economic studies
  • Fertility
    • Clinical utility of AMH
    • Method comparison studies (to AFC or other biomarker assays)
  • NIPT
    • Comparison of available technologies
    • Health economic studies
Out of Scope
We have little interest in study submissions involving:
  • Strategies not incorporating Roche products
Platforms
We can support studies on the following systems:
  • cobas e 411
  • cobas e 601
  • cobas e 602
  • cobas e 801

*The Harmony Prenatal Test was developed by Ariosa Diagnostics, a CLIA-certified laboratory. As with other laboratory-developed tests, it has not been cleared or approved by the FDA and is not available for sales as an IVD in the U.S. Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing.

Study Proposal Considerations
  1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
  2. Is the research proposal unique and of major scientific or medical importance?
  3. Do we have resources to support it?

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