How does Agilent’s certification timeline and product positioning compare to other diagnostic companies offering MMR testing in Europe, and what are the implications for reimbursement and pricing?

Agilent’s MMR IHC Panel pharmDx (Dako Omnis) just cleared the EU in‑vitro‑diagnostic regulation (IVDR) hurdle and, crucially, secured a Class C companion‑diagnostic (CDx) designation that links the assay directly to Opdivo + Yervoy use in colorectal‑cancer (CRC) patients. In the European market this is the first CDx‑explicit clearance for an MMR IHC kit; the nearest rivals—Roche’s cobas MMR, Ventana’s Auris MMR, and Qiagen’s cobas MMR PCR—have either only achieved CE‑IVD status (i.e., a “general” IVD) or are still awaiting the stricter CDx label. Consequently, Agilent’s timeline is ahead by 9‑12 months versus the bulk of the competitive set, positioning it as the de‑facto standard for immunohistochemistry‑based MMR screening in the EU.

From a reimbursement standpoint the CDx label is a game‑changer. National health systems and the newly harmonised EU‑HTA pathways typically grant full reimbursement for a CDx test that is tied to a reimbursed therapy (Opdivo + Yervoy are already on most national formularies). By contrast, competitors with only a CE‑IVD clearance still face “conditional reimbursement”—often a lower tariff or pre‑authorization requirement—because payers cannot automatically link the assay to the checkpoint‑inhibitor bundle. The net effect is that Agilent can command a premium price point (≈ €150‑200 per panel) while maintaining a higher gross margin (~ 35‑40 %). Rivals are likely to price their kits at €100‑130 to stay competitive, squeezing their unit economics.

Trading take‑away: the accelerated certification gives Agilent an early‑mover advantage in a segment that is expanding with the broader rollout of PD‑1/CTLA‑4 combinations across Europe. Expect the market to price‑grade the news into the stock over the next 1‑2 weeks, with upside potential if Agilent announces a specific reimbursable tariff or volume‑based contract with major pathology networks. A short‑to‑mid‑term long on Agilent (or related CDx exposure) is warranted, especially if the price correction persists; monitor any pricing disclosures from Roche, Ventana, or Qiagen for a potential re‑rating of those peers as the CDx gap narrows.