Pivotal Trials

Directly create a diagnostic product to enable a differentiated commercial strategy using our technology.

Companion Diagnostics

Differentiate your commercial strategy and increase probability of success.

Flagship is the ideal partner when you need to establish commercial differentiation by:

  • Designing, evaluating, and implementing a prototype diagnostic strategy in a regulated space, to
  • Accelerate development and increase the probability of diagnostic success through confident decision making.

Flagship creates novel diagnostic approaches by:

  • Integrating our technology into existing IHC based CDx formats, which requires only the addition of our software.
  • Utilizing our in-house Quality Management System (QMS), which is in compliance with ISO13485, ISO14971, IEC62304 and FDA 21 CFR Part 820 QSR.

Flagship’s cTA® platform has 7 granted patents and over 19 patents pending.

Proven Success

We are very pleased to work with Flagship’s image analysis with mRNA ISH, which is particularly important for the development of companion diagnostics.

Dr. Xiao-Jun Ma, CSO of ACD


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Breadth and depth in people and technology to deliver on any challenge
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