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Clinical Diagnostics · Epigenetics

Market access and payer strategy for a next-generation epigenetics company.

Partnered with Infinite Epigenetics on commercial strategy, coding pathway, and payer engagement.

Challenge

An early-stage epigenetics company had developed a next-generation testing platform and was preparing to enter a market where the incumbents had already secured the billing codes, the coverage policies, and the payer relationships. The science was differentiated, but differentiation doesn't collect revenue — reimbursement infrastructure does.

The company faced the classic early-diagnostics bind: it needed a clear commercial strategy to raise capital and attract partners, yet the coding, coverage, and payment work that determines revenue runs on multi-month and multi-year timelines that can't be compressed. Leadership needed to know where to invest first, what revenue was realistically achievable in the near term, and how to sequence payer engagement so early wins funded the longer coverage journey.

Approach

Wellguidant Advisors built an integrated commercial and reimbursement strategy that treated payer dynamics as the organizing principle for every downstream decision.

  • Coding pathway: Evaluated the company's options for establishing billing identity — proprietary PLA codes versus existing codes — and sequenced the applications so the earliest revenue-generating tests carried billing infrastructure first.
  • Payer landscape mapping: Profiled the Medicare, Medicare Advantage, and commercial payer environment for epigenetic testing, including the MolDx program's evidence expectations, to identify where coverage could be pursued on existing policy and where new policy development would be required.
  • Evidence planning: Translated payer requirements into a prioritized evidence-development agenda — analytical validity, clinical validity, and clinical utility — aligned with the company's budget and publication timeline.
  • Commercial sequencing: Identified the access channels and customer segments where testing could generate revenue ahead of broad coverage — including self-pay and contracted pathways — and built the launch sequencing around them.
  • Payer engagement readiness: Developed the stakeholder-facing materials — value dossiers, coverage rationale, and payer talking points — the company would need once payer discussions began.
Outcome

The company moved into the market with a sequenced plan rather than a wish list: coding applications in motion, an evidence agenda tied directly to payer requirements, and near-term revenue channels identified that don't depend on broad coverage. The strategy also gave leadership the grounded commercial narrative it needed for fundraising and partnership conversations.

Why it mattered

In a category where the first movers already own the payer relationships, the difference between a strong launch and a stalled one is sequencing. By anchoring every commercial decision to the reimbursement timeline, the company could build momentum it controlled while the coverage decisions it didn't control matured in parallel.

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