Entering the U.S. diagnostics market?
DMC helps international diagnostic companies evaluate and coordinate the scientific, reimbursement, commercialization, laboratory, and revenue-cycle requirements involved in U.S. market entry.
Your U.S. commercialization quarterback.
The U.S. market rewards assays that are scientifically ready, correctly coded, credibly evidenced, and operationally billable. DMC acts as the single senior point of accountability across that sequence — structuring the pathway, sequencing the decisions, and engaging the right specialists at the right moment rather than leaving a foreign management team to assemble a dozen disconnected U.S. advisors.
DMC coordinates and supports the pathway. We do not represent that we alone provide every regulatory approval or every specialist discipline a program may require.
What we help you evaluate and coordinate.
- 01
Scientific & laboratory readiness
Validation expectations, documentation, and the CLIA laboratory arrangements required to run or place the assay in the U.S. - 02
Coding pathway
How the assay is likely to be coded, including PLA/CPT considerations where applicable, and what that means for payment strategy. - 03
Coverage & evidence
Payer evidence expectations, coverage planning, and MolDX-related considerations where applicable. - 04
Commercial model
Direct, distributor, laboratory-partner, or health-system routes to market, and the contracting implications of each. - 05
Revenue cycle
The billing, prior authorization, denial, and collections realities a U.S. program must be built to withstand. - 06
Specialist coordination
Regulatory, legal, and technical specialists brought in where required, with DMC keeping the pathway coherent.