Abstract
This report is a unique compilation of historical companion diagnostic
products, business models for drug/diagnostic collaborations, education &
marketing, intellectual property, regulatory, and reimbursement information
for those interested in developing companion diagnostics, as well as
stand-alone diagnostics
The report:
- Will help diagnostics companies avoid the pitfalls and get the best deal
when partnering with pharmaceutical companies on diagnostic/therapy
combination products
- Will help diagnostics companies plan the most effective regulatory and
reimbursement strategies for commercial success
- Will enable diagnostics companies to assess their competition in
developing diagnostic products for pharma companies
- Will enable pharmaceutical companies to get the best from diagnostic
collaborations
This publication answers key questions such as:
- What are the US in vitro diagnostic regulatory guidelines?
- What are the in vitro diagnostic regulatory guidelines outside of the US?
- Why is a diagnostic contract research organization (CRO) useful?
- What are main intellectual property issues to keep in mind?
- What is the difference between an ASR and a 510K?
- How can a company estimate the dollar value a companion diagnostic can add
to a therapeutic?
- Why companion diagnostic will not necessarily ruin a therapeutics market?
- How a company can meet both commercial and non-profit goals?
- What does the FDA have to say about pharmacogenomics?
- What are the steps for validating a clinical assay?
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