Companion Diagnostics Regulatory Approval

 

Regulatory requirements for Companion Diagnostics

Lab21 has strong global diagnostics presence and is a major provider of Companion Diagnostics services. We can support you in the selection of the most suitable Companion Diagnostics strategy, and deliver this strategy according to your requirements.

The regulatory requirements for a Companion Diagnostics (CDx) or other diagnostics associated with patient treatment decisions and monitoring depend on:
  • Target market(s)
  • Whether the CDx is a product or a service
  • Whether use of the CDx is required on the drug label
The cost of diagnostics development depends significantly on the regulatory requirements to be fulfilled. The cost of the diagnostic, in turn, may affect its adoption and reimbursement in the target markets. Alternative, differentially priced companion diagnostic strategies may be useful for different markets.

The comprehensive, integrated Lab21 Quality System and our resulting, fully accredited product (ISO 9001, ISO 13485, GMP) and laboratory service (ISO 9001, CPA (ISO 15189), CLIA) operations enable us to develop products and/or laboratory services to meet the following:

For the US market:
  • 510(k) or PMA products
  • LDT services through our US CLIA laboratory

For European and many other markets:
  • CE/IVD products
  • CPA (ISO 15189) and ISO 9001 accredited services
  • GCLP accredited services for clinical trials

We are also able to fulfill additional country or market specific regulatory requirements.