Sera Prognostics, Inc.

What they do

Sera Prognostics develops and commercializes pregnancy biomarker tests, primarily the PreTRM test, which uses proteomic analysis of a blood sample to assess a pregnant individual's risk of spontaneous preterm birth. The company sells the test to clinicians, health systems and payers in the United States while pursuing reimbursement and regulatory clearance in Europe. It is headquartered in Salt Lake City, Utah.

Revenue drivers

• PreTRM test — The company states substantially all revenue to date derives from the PreTRM test; annual revenue was $81,000 in 2025 and $14,000 in Q1 2026, underscoring how early commercial volumes remain.
• Payer and partnership programs — Sera is pursuing coverage through payer engagements and partnership programs, including a fourth partnership program launched in August 2026 with a national payer in a state-based initiative; these programs are intended to drive test adoption rather than represent separate product revenue.
• Illinois Medicaid mandate — Illinois enacted Public Act 104-0470 in June 2026 requiring Medicaid coverage of prescribed proteomic blood tests for spontaneous preterm birth risk; the state confirmed coverage applies to all Illinois Medicaid pregnancies, approximately 50,000 annual births.
• European market entry — Sera is completing a CE marking submission package with pre-application activities expected in Q3 2026 and submission targeted in Q4 2026, but no European revenue is reported.

Recent performance

Second quarter 2026 revenue was $30,000, up sequentially from $14,000 in Q1 2026 and $10,000 in Q4 2025. The company reported a net loss in each of the last five fiscal years, including a $31.9 million net loss for 2025, with operating cash use of $25.6 million in 2025. Diluted EPS improved from -$2.33 in 2021 to -$0.67 in 2025. As of June 30, 2026, Sera had $4.4 million in cash and equivalents on the balance sheet but approximately $80.3 million in cash, cash equivalents and available-for-sale securities, per its earnings release.

Strategy

Management is focused on commercial adoption of PreTRM through payer engagement, policy wins and partnership programs, and reported exceeding its 2026 payer engagement objective with active discussions across more than 20 payer opportunities in over 20 states. The company is investing in clinical evidence generation, including PRIME trial analyses presented at SMFM Global Congress 2026 and a July 2026 publication showing a 22% reduction in NICU admissions among first-time mothers. It is also building European regulatory readiness with a CE marking submission targeted for Q4 2026. Sera strengthened commercial leadership in marketing and payer and government strategy and appointed diagnostics veteran Mark Capone to its board. Management states it believes its cash position funds operations through significant adoption and commercialization milestones through 2029.

Risks

• History of losses — Sera has incurred net losses since inception, including $31.9 million in 2025, and expects losses to continue for the foreseeable future.
• Revenue concentration — Substantially all revenue comes from the PreTRM test, and the company expects near-term reliance on a limited number of direct customers.
• Capital needs — Operating the business requires significant cash, and failure to raise additional capital when needed could force Sera to curtail or cease operations.
• Quarterly fluctuation — Quarterly and annual results have fluctuated sharply, with revenue ranging from $10,000 to $30,000 across the last four reported quarters.

Outlook

Management points to payer engagement, the Illinois Medicaid coverage mandate, clinical evidence and European regulatory progress as drivers of future adoption. It expects European pre-application activities in Q3 2026 and CE marking submission by Q4 2026. The company believes its cash, cash equivalents and available-for-sale securities will fund operations through significant adoption and commercialization milestones through 2029. No specific revenue guidance is provided in the excerpts.