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Florida Medicaid covers Sera's PreTRM test as company starts CE Mark submission

🇺🇸 Sera Prognostics, Inc. (SERA) · Wed 04 Nov 2026

Sera Prognostics reports Florida as the second state Medicaid programme to cover its preterm birth risk test, while it begins EU certification for a kit-based version.

Sera Prognostics reported results for the third quarter ended 30 September 2026 on 4 November. The company said Florida's Medicaid programme has added its PreTRM preterm birth risk test, which carries PLA code 0247U, to its covered list and laboratory fee schedule. Illinois was the first state to do so.

The company's announcement headline also cites a 54% rise in PreTRM volume. The information available does not specify the comparison period or the absolute number of tests.

Test revenue for the quarter was $42,000, and cash stood at $72.8 million at the end of the period.

Sera has also begun a CE Mark submission with its notified body for PreTRM Global, a kit-based version of the test. CE marking is the route to placing a medical device on the EU market, and notified bodies assess conformity for many diagnostic products. No timeline for a decision was given in the material available.

What it means for your team

  • Market-access teams tracking prenatal diagnostics can note that state Medicaid coverage for PreTRM now spans two states, Illinois and Florida, with a defined PLA code (0247U) and a place on the lab fee schedule.
  • Revenue of $42,000 for the quarter shows that coverage decisions have yet to translate into large-scale commercial uptake.
  • Regulatory teams should watch the CE Mark process for the kit-based PreTRM Global test, as it would be the first step towards distributing a kit outside a single-laboratory model.

Company's press release (SEC filing): Sera Prognostics, Inc. ↗

Article written by VigiEye from the official source (Sera Prognostics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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