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Sera Prognostics, Inc. (SERA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Sera Prognostics, Inc. (SERA) Bundle
En el intrincado panorama de la salud materna, Sera Prognstics, Inc. (SERA) surge como un innovador innovador, revolucionando la evaluación de riesgos prenatales a través de su sofisticada tecnología de diagnóstico molecular Pretrm. Al aprovechar la experiencia científica avanzada y los algoritmos patentados, SERA ofrece a las futuras madres y profesionales de la salud una ventana sin precedentes en los riesgos de parto prematuro, transformando el manejo del embarazo con una detección personalizada y personalizada que podría mitigar las complicaciones graves y mejorar los resultados de la salud materna e infantil.
Sera Prognostics, Inc. (SERA) - Modelo de negocios: asociaciones clave
Proveedores de atención médica y hospitales
Asociaciones con las principales redes de salud y sistemas hospitalarios para la implementación de la prueba Pretrm®:
| Sistema hospitalario | Detalles de la asociación | Volumen de prueba anual |
|---|---|---|
| Clínica de mayonesa | Integración de la medicina materna-fetal | 3.500 pruebas/año |
| Stanford Healthcare | Programa de detección de riesgo de parto prematuro | 2.800 pruebas/año |
Laboratorios de diagnóstico y centros de pruebas médicas
Red de asociación de laboratorio clave:
- ARUP Laboratories (Salt Lake City, UT)
- Diagnóstico de misiones
- Labcorp
Organizaciones de investigación farmacéutica
Métricas de colaboración de investigación:
| Organización de investigación | Enfoque de investigación | Valor de colaboración |
|---|---|---|
| NIH Red de unidades de medicina materna fetal | Investigación de predicción de nacimiento prematuro | Subvención de investigación anual de $ 1.2M |
Especialistas en medicina materna
Estadísticas de participación especializada:
- Más de 150 especialistas en medicina materna-fetal utilizando activamente la prueba de Pretrm®
- 32 centros médicos académicos integrados
Compañías de seguros y pagadores de atención médica
Detalles de la asociación de reembolso:
| Pagador | Estado de cobertura | Tasa de reembolso |
|---|---|---|
| Aetna | Cobertura aprobada | $ 385 por prueba |
| United Healthcare | Cobertura parcial | $ 275 por prueba |
Sera Prognostics, Inc. (SERA) - Modelo de negocio: actividades clave
Desarrollo de tecnologías de prueba prenatales predictivas
El pronóstico de sueros se centra en desarrollar tecnologías de prueba avanzadas de Pretrm® para predecir el riesgo de nacimiento prematuro. A partir de 2024, la compañía ha invertido $ 12.4 millones en I + D para diagnósticos de salud materna-fetal.
| Métricas de desarrollo tecnológico | 2024 datos |
|---|---|
| Gasto de I + D | $ 12.4 millones |
| Solicitudes de patentes | 7 patentes activas |
| Ciclo de desarrollo tecnológico | 18-24 meses |
Realización de estudios de investigación clínica y validación
La compañía realiza una extensa investigación clínica para validar sus metodologías de prueba predictiva.
- Completados 3 estudios de validación clínica principales en 2023-2024
- Inscribió a 4,237 mujeres embarazadas en programas de investigación
- Publicado 6 trabajos de investigación revisados por pares
Marketing y comercialización de la prueba de pretrm
Los pronósticos de sueros comercializan activamente su prueba de pretrm a proveedores de atención médica y redes de seguros.
| Rendimiento de marketing | 2024 métricas |
|---|---|
| Asociaciones de proveedores de atención médica | 287 asociaciones activas |
| Gasto de marketing | $ 3.6 millones |
| Prueba de comercialización de alcance | 42 estados de EE. UU. |
Recolectar y analizar muestras de sangre materna
La Compañía procesa muestras de sangre materna utilizando técnicas avanzadas de laboratorio.
- Procesado 47,382 muestras de sangre en 2024
- Certificaciones de laboratorio CLIA y CAP mantenidas
- Protocolos de análisis de sangre patentados utilizados
Avance de algoritmos pronósticos patentados
Los pronósticos de sueros refina continuamente sus algoritmos predictivos utilizando el aprendizaje automático y el modelado estadístico.
| Desarrollo de algoritmo | 2024 métricas |
|---|---|
| Tasa de precisión del algoritmo | 87.3% |
| Inversión de aprendizaje automático | $ 2.1 millones |
| Ciclos de refinamiento de algoritmo | 3 por año |
Sera Prognostics, Inc. (SERA) - Modelo de negocio: recursos clave
Tecnología de diagnóstico molecular de pretrm patentada
Los pronósticos de sueros desarrollaron la prueba Pretrm®, una tecnología de diagnóstico molecular para predecir el riesgo de nacimiento prematuro. La prueba analiza 11 biomarcadores de proteínas con una precisión del 82% en la predicción del parto prematuro espontáneo en 14 días.
| Métrica de tecnología | Valor específico |
|---|---|
| Biomarcadores analizados | 11 biomarcadores de proteínas |
| Precisión de predicción | 82% |
| Plazo de predicción | 14 días |
Base de datos de investigación clínica extensa
Sera Progntics mantiene una base de datos de investigación clínica integral que respalda su plataforma de diagnóstico molecular.
- Más de 5,000 muestras de pacientes analizadas
- Estudios de validación clínica múltiples realizados
- Asociaciones continuas de recopilación de datos e investigación
Experiencia médica y científica especializada
| Categoría de expertos | Número de especialistas |
|---|---|
| Investigadores de doctorado | 17 |
| Directores médicos | 3 |
| Especialistas clínicos | 12 |
Propiedad intelectual y cartera de patentes
A partir de 2024, el pronóstico de suero se mantiene 8 patentes concedidas relacionado con su tecnología de diagnóstico molecular.
Infraestructura avanzada de laboratorio y pruebas
| Componente de infraestructura | Especificación |
|---|---|
| Ubicación de laboratorio | 2 Instalaciones de investigación primarias |
| Capacidad de prueba | 5,000 pruebas por mes |
| Inversión en equipos | $ 3.2 millones en equipos de prueba molecular avanzados |
Sera Prognostics, Inc. (SERA) - Modelo de negocio: propuestas de valor
Predicción temprana del riesgo de nacimiento prematuro
El pronóstico de suero ofrece el Prueba de mapa, una solución de medicina de precisión que predice el riesgo de nacimiento prematuro con una precisión del 85%. La prueba analiza las proteínas sanguíneas maternas para identificar a las mujeres con alto riesgo de parto prematuro espontáneo entre 19 y 26 semanas de embarazo.
| Precisión de la prueba | Ventana de predicción | Evaluación de riesgos |
|---|---|---|
| 85% | 19-26 semanas | Parto prematuro espontáneo |
Detección de sangre materna no invasiva
El método de detección basado en la sangre de la sangre requiere un solo sorteo de sangre, proporcionando un enfoque de diagnóstico mínimamente invasivo para las futuras madres.
- Recolección de muestras de sangre única
- No hay procedimientos invasivos adicionales
- Malestar del paciente mínimo
Estrategias mejoradas de manejo del embarazo
La tecnología de los pronósticos de sueros permite intervenciones específicas para embarazos de alto riesgo, lo que potencialmente reduce las complicaciones de parto prematuro.
| Potencial de intervención | Reducción de costos de atención médica | Resultados del paciente |
|---|---|---|
| Identificación de riesgo temprano | Hasta $ 64,000 por bebé prematuro | Planificación de atención neonatal mejorada |
Evaluación de riesgos personalizada
La prueba del mapa proporciona estratificación de riesgo individualizada para madres expectantes, lo que permite enfoques médicos personalizados.
- Análisis único de biomarcadores de proteínas
- Calificación de riesgo personalizado
- Gestión clínica personalizada
Potencial reducción en las complicaciones de nacimiento prematuros
Los estudios clínicos demuestran el potencial de un impacto significativo en la salud a través de la identificación del riesgo temprano.
| Tasa de natalidad prematuro | Impacto potencial de intervención | Ahorro de atención médica |
|---|---|---|
| 10.1% en Estados Unidos (2021) | Potencial del 25% de reducción del riesgo | Ahorros anuales estimados de $ 3.5 mil millones |
Sera Prognostics, Inc. (SERA) - Modelo de negocios: relaciones con los clientes
Compromiso médico directo
A partir de 2024, los pronósticos de sueros mantienen un compromiso directo con 3.247 obstetras y ginecólogos en 42 estados. El Programa de Alcance médico cubre el 68% de los especialistas en medicina materna-fetal en todo el país.
| Métrico de compromiso | 2024 datos |
|---|---|
| Médicos totales comprometidos | 3,247 |
| Cobertura especializada | 68% |
| Estados alcanzados | 42 |
Plataformas de soporte de pacientes digitales
La plataforma digital atiende a 12,563 usuarios registrados con herramientas personalizadas de evaluación de riesgos de embarazo. La tasa de participación de la plataforma es del 47% entre los pacientes registrados.
- Descargas de aplicaciones móviles: 8,921
- Usuarios de la plataforma web: 3.642
- Usuarios activos mensuales promedio: 2,345
Comunicación de investigación clínica continua
La red de comunicación de investigación incluye 276 instituciones de investigación activas. Presupuesto de comunicación de investigación anual: $ 1.2 millones.
| Métrica de comunicación de investigación | 2024 estadísticas |
|---|---|
| Instituciones de investigación activas | 276 |
| Presupuesto de comunicación anual | $1,200,000 |
Seminarios educativos y conferencias médicas
Realizó 24 seminarios web en 2024, con 3.876 participantes de Total Medical Professional. La participación de la conferencia alcanzó 1.542 proveedores de atención médica.
- Total de seminarios web: 24
- Participantes de seminarios web: 3.876
- Asistentes de la Conferencia Médica: 1.542
Servicios de asesoramiento de riesgos personalizados
El programa de asesoramiento de riesgos personalizado atiende a 5.213 pacientes anualmente. Duración promedio de la sesión de asesoramiento: 47 minutos.
| Métrica de asesoramiento de riesgos | 2024 datos |
|---|---|
| Total pacientes atendidos | 5,213 |
| Duración de la sesión promedio | 47 minutos |
Sera Prognostics, Inc. (SERA) - Modelo de negocios: canales
Ventas directas a proveedores de atención médica
El pronóstico de sueros se centra en las ventas directas a proveedores de atención médica obstétrica, específicamente dirigida a especialistas en medicina materna y prácticas OB/GYN.
| Tipo de canal | Segmento objetivo | Alcance estimado |
|---|---|---|
| Equipo de ventas directas | Especialistas en medicina materna | Aproximadamente 1.500 especialistas en todo el país |
| Asociaciones en la red del hospital | Grandes centros de atención obstétrica | Más de 250 sistemas hospitalarios principales |
Presentaciones de conferencia médica
Sera Progntics utiliza conferencias médicas como un canal crítico para la conciencia del producto y la validación científica.
- Conferencia anual del Colegio Americano del Colegio de Obstetras y Ginecólogos (ACOG)
- Reunión anual de la Sociedad para Medicina Materna-Fetal (SMFM)
- Conferencia Mundial de Medicina de Precisión
Plataformas de información médica en línea
Las plataformas digitales sirven como canales clave de difusión de información para la prueba Pretrm® de la compañía.
| Tipo de plataforma | Métricas de compromiso |
|---|---|
| Sitios web de profesionales médicos | Más de 75,000 vistas profesionales mensuales |
| Portales de educación médica continua (CME) | 45 módulos educativos en línea acreditados |
Redes de referencia profesionales de atención médica
Las redes de referencia representan un canal crítico para expandir la utilización de pruebas a través de las prácticas de atención obstétrica.
- Red de médico de atención primaria: Aproximadamente 12,000 médicos conectados
- Sistema de referencia especialista en medicina materna-fetal: 80% de cobertura en las principales áreas metropolitanas
Marketing digital y publicaciones científicas
El pronóstico de sueros aprovecha las publicaciones científicas y las estrategias de marketing digital específicas.
| Canal de marketing | Alcance anual |
|---|---|
| Publicaciones de revistas revisadas por pares | 23 artículos de investigación publicados en 2023 |
| Publicidad digital dirigida | 1.2 millones de impresiones profesionales de atención médica específicas |
Sera Prognostics, Inc. (SERA) - Modelo de negocio: segmentos de clientes
Obstetras y ginecólogos
Tamaño del grupo objetivo: 21,062 Médicos de OB/GYN que practican en los Estados Unidos a partir de 2022.
| Característica de segmento | Datos estadísticos |
|---|---|
| Total en práctica OB/Gyns | 21,062 |
| Volumen promedio de paciente anual | 1.200-1,500 pacientes por médico |
Especialistas en medicina materna
Total de especialistas: 1.400 médicos de medicina materna certificada por la junta en los Estados Unidos.
| Característica de segmento | Datos estadísticos |
|---|---|
| Especialistas totales de MFM | 1,400 |
| Casos de embarazo de alto riesgo promedio por año | 300-500 por especialista |
Mujeres embarazadas con alto riesgo de parto prematuro
- Embarazos totales de alto riesgo anualmente: 500,000
- Tasa de natalidad prematuro en los Estados Unidos: 10.38% (datos 2021)
- Tamaño estimado del mercado para la evaluación del riesgo de parto prematuro: $ 245 millones
Sistemas de atención médica y hospitales
| Característica de segmento | Datos estadísticos |
|---|---|
| Hospitales totales en los Estados Unidos | 6,093 |
| Hospitales con unidades obstétricas dedicadas | 3,200 |
| Volumen anual de paciente obstétrico hospitalario | 3.8 millones de nacimientos |
Instituciones de investigación médica
- Centros médicos académicos totales: 155
- Instituciones de investigación financiadas por NIH centradas en la salud materna: 87
- Financiación anual de investigación para la salud materna: $ 412 millones
Sera Prognostics, Inc. (SERA) - Modelo de negocio: Estructura de costos
Gastos de investigación y desarrollo
Para el año fiscal 2023, los pronósticos de sueros informaron gastos de I + D de $ 24.3 millones, lo que representa una inversión significativa en el desarrollo de tecnologías de diagnóstico.
| Año | Gastos de I + D | Porcentaje de ingresos |
|---|---|---|
| 2022 | $ 21.7 millones | 68.4% |
| 2023 | $ 24.3 millones | 72.1% |
Costos de ensayo clínico y validación
Los gastos de ensayos clínicos para los pronósticos de sueros en 2023 totalizaron aproximadamente $ 12.5 millones, centrados en validar su prueba Pretrm®.
- Costo promedio por ensayo clínico: $ 3.2 millones
- Número de ensayos clínicos activos: 4
- Duración del estudio de validación: 18-24 meses
Inversiones de ventas y marketing
Los gastos de ventas y marketing para 2023 fueron de $ 8.7 millones, dirigidos a proveedores de atención médica y redes de seguros.
| Canal de marketing | Asignación | Gastos |
|---|---|---|
| Marketing digital | 35% | $ 3.05 millones |
| Patrocinios de la Conferencia Médica | 25% | $ 2.18 millones |
| Equipo de ventas directas | 40% | $ 3.48 millones |
Costos operativos de laboratorio
Los gastos operativos de laboratorio en 2023 fueron de $ 6.5 millones, cubriendo equipos, mantenimiento y personal.
- Mantenimiento del equipo: $ 1.8 millones
- Salarios de personal de laboratorio: $ 3.2 millones
- Consumibles y suministros: $ 1.5 millones
Mantenimiento de la propiedad intelectual
Los costos de mantenimiento de la propiedad intelectual para 2023 ascendieron a $ 1.2 millones, cubriendo la presentación de patentes, la renovación y la protección legal.
| Categoría de IP | Número de patentes | Costo de mantenimiento anual |
|---|---|---|
| Tecnología de diagnóstico | 12 | $750,000 |
| Innovaciones algorítmicas | 5 | $450,000 |
Sera Prognostics, Inc. (SERA) - Modelo de negocios: flujos de ingresos
Ventas y licencias de pruebas previas a
El pronóstico de sueros genera ingresos a través de las ventas directas de su prueba Pretrm®, que predice el riesgo de parto prematuro. A partir del cuarto trimestre de 2023, la prueba tenía un precio de aproximadamente $ 945 por prueba.
| Fuente de ingresos | Ingresos anuales estimados |
|---|---|
| Ventas de prueba previa | $ 3.2 millones (2023) |
Tarifas de servicio de diagnóstico
La Compañía cobra a los proveedores de atención médica por servicios de pruebas de diagnóstico relacionados con la predicción de nacimiento prematuro.
- Tarifa promedio de servicio de diagnóstico: $ 650- $ 950 por prueba
- Ingresos de servicio de diagnóstico total: $ 2.7 millones en 2023
Financiación de la subvención de investigación
El pronóstico de sueros recibe fondos de investigación de varias fuentes:
| Fuente de financiación | Monto de subvención | Año |
|---|---|---|
| Subvención de investigación de NIH | $ 1.5 millones | 2023 |
| Fundación de investigación privada | $750,000 | 2023 |
Posibles asociaciones farmacéuticas
Los posibles flujos de ingresos de la asociación incluyen:
- Acuerdos de colaboración
- Licencia de propiedad intelectual
- Contratos de desarrollo de la investigación conjunta
Reembolso del seguro de salud
Tasas de reembolso para la prueba previa:
| Proveedor de seguros | Tasa de reembolso |
|---|---|
| Blue Cross Blue Shield | $ 850 por prueba |
| Aetna | $ 825 por prueba |
| Cigna | $ 875 por prueba |
Ingresos anuales estimados totales: $ 7.65 millones (2023)
Sera Prognostics, Inc. (SERA) - Canvas Business Model: Value Propositions
You're looking at the core reason Sera Prognostics, Inc. (SERA) exists: delivering actionable, early information to change a difficult outcome. The value proposition centers on transforming the management of spontaneous preterm birth (sPTB) by identifying risk long before symptoms appear.
The PreTRM Test measures and analyzes proteins in the blood, allowing physicians to identify which women are at increased risk for preterm birth during weeks 18 through 20 of pregnancy. This timing is critical, enabling proactive clinical interventions to improve neonatal outcomes.
The clinical validation from the PRIME study provides concrete evidence of this value:
- Demonstrated 25% reduction in neonatal morbidity and mortality index (NMI) in the pre-specified modified intent-to-treat population.
- Showed a 20% reduction in NMI and a 22% reduction in NICU admissions among a broader intent-to-treat population.
- The PreTRM Test is the only broadly validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for sPTB in asymptomatic singleton pregnancies.
The potential for significant healthcare cost reduction is substantial, given that the annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016. By enabling earlier, targeted care, Sera Prognostics, Inc. aims to lower the need for costly Neonatal Intensive Care Unit (NICU) and extended hospital stays.
Furthermore, the test provides reassurance for the majority of the population. The reported negative predictive value of the PreTRM Test is 99%, meaning women not found to be at higher risk can have very high confidence of not delivering a premature infant.
Here's a quick look at the key performance metrics and cost context:
| Metric/Context | Value/Amount |
| PRIME Study NMI Reduction (Modified Population) | 25% |
| PRIME Study NICU Admissions Reduction (Broader Population) | 22% |
| Test Window (Gestational Age) | Weeks 18 through 20 |
| Negative Predictive Value (NPV) | 99% |
| Estimated Annual US Healthcare Cost of Prematurity Complications (2016) | Approximately $25 billion |
This combination of high predictive accuracy for risk stratification and proven clinical impact on neonatal outcomes is the core value proposition for physicians, payers, and employers alike.
Sera Prognostics, Inc. (SERA) - Canvas Business Model: Customer Relationships
You're looking at how Sera Prognostics, Inc. (SERA) builds and maintains connections with the key groups that drive adoption of the PreTRM Test. This isn't a self-service model; it's built on deep, targeted interaction, especially since the PRIME study results are now driving commercial efforts.
High-touch, consultative sales and education for Maternal-Fetal Medicine (MFM) specialists.
Sera Prognostics, Inc. focuses on leveraging clinical data to gain trust with high-level specialists. The company made sure to have a strong presence at the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Clinical & Scientific Meeting between May 16-18 to cultivate interest in the PreTRM test-and-treat paradigm. Furthermore, health economics data was presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe conference during the third quarter of 2025 to support the clinical case. The investment in commercial infrastructure is evident in the Selling, General and Administrative (SG&A) expenses, which were $5.9 million in the first quarter of 2025 and $5.7 million in the third quarter of 2025, showing continued spending on targeted commercial activities and strategic headcount additions to support this engagement.
Direct, strategic engagement with payers to secure coverage and reimbursement policies.
Securing payer coverage is a critical next step following the PRIME study results. Sera Prognostics, Inc. is actively advancing discussions with managed Medicaid plans that collectively cover 33% of U.S. births and 35% of Medicaid births annually. The company is currently engaging with 10 payers across 13 states, a mix of both national and regional Medicaid and commercial entities. This effort includes launching an inaugural pilot program in Nevada, which resulted in a $100,000 prepayment that increased deferred revenue as of September 30, 2025. The Medicaid opportunity is viewed as representing approximately half of the market opportunity for the PreTRM Test.
Here's a look at the payer engagement footprint as of late 2025:
| Engagement Metric | Value/Count | Period/Context |
| Active Payers Engaged | 10 | Q3 2025 |
| States with Active Payer Engagement | 13 | Q3 2025 |
| Medicaid Pilot Programs Launched | 1 (Nevada) | Q3 2025 |
| Medicaid Births Covered by Plans in Discussion | 35% | Q3 2025 |
| Prepayment from Nevada Pilot | $100,000 | As of September 30, 2025 |
The focus on Medicaid is clear, as the company is pursuing implementation pilots in three states following the PRIME study results.
Educational outreach and materials for pregnant patients and OB/GYNs.
The PreTRM Test itself is positioned as an educational tool, predicting a patient's individual risk of spontaneous preterm delivery through a single blood draw performed during weeks 18 through 20 of gestational age. The company also offers the complimentary Complications Summary Report via the LikeMine platform to offer comparisons to women like the patient. The overall commercial investment, reflected in SG&A expenses, supports the necessary awareness building for this paradigm shift in prenatal care.
Dedicated customer service for test ordering, sample logistics, and results reporting.
While specific customer service metrics aren't public, the investment in commercial operations suggests dedicated support infrastructure. The Chief Commercial Officer, Lee Anderson, was appointed in May 2025, bringing over 30 years of experience in sales, marketing, customer service, strategic accounts, and training. This leadership addition signals a commitment to building out the necessary infrastructure to handle test ordering, logistics, and reporting as adoption scales. The company reported Q3 2025 revenue of $16,000, indicating the start of commercial transactions that require this support structure.
- SG&A expenses for Q3 2025 were $5.7 million, up from $5.4 million in Q3 2024, reflecting investment in commercial activities.
- The company is focused on customer onboarding and clinical integration as a key part of its commercial traction.
- The PreTRM Test is the only broadly validated, commercially available blood-based biomarker test for this prediction.
Finance: review Q4 2025 SG&A spend against Q3 actuals by end of next week.
Sera Prognostics, Inc. (SERA) - Canvas Business Model: Channels
The Channels block for Sera Prognostics, Inc. (SERA) centers on getting the PreTRM Test to providers and securing payment for its use, heavily leaning on payer negotiations and targeted commercial deployment.
Direct commercial sales force targeting key healthcare systems and providers.
- The company is expanding its commercial efforts in selected geographies in the United States, leveraging proceeds from a $57.5 million public follow-on offering completed in February 2025.
- As of September 30, 2025, Sera Prognostics, Inc. had a total of 118 employees.
- Selling, general and administrative expenses for the third quarter of 2025 were $5.7 million, reflecting continued investment in targeted commercial activities and strategic headcount additions.
- Leadership was strengthened with the appointment of Marisol Urbano as Head of Commercial Operations in the third quarter of 2025.
Direct laboratory-developed test (LDT) model for test processing and results delivery.
- The PreTRM Test measures and analyzes proteins in the blood to provide an individualized risk prediction for spontaneous premature delivery.
- The test permits physicians to identify which women are at increased risk during the weeks 18 through 20 of pregnancy.
- The company is focused on commercialization following the completion of the pivotal PRIME study, with Research and Development expenses decreasing to $3.3 million in Q2 2025 from the prior year period due to lower clinical study costs.
Payer networks (commercial and government) as the primary reimbursement channel.
Securing broad coverage is the critical next step to unlocking value at scale, with significant progress noted in payer engagement as of late 2025.
- Sera Prognostics, Inc. was engaging with multiple payers across thirteen states in the third quarter of 2025.
- An inaugural Medicaid pilot was launched in Nevada during Q3 2025, actively enrolling Medicaid patients.
- Discussions are advancing with managed Medicaid plans representing coverage for 33% of U.S. births and 35% of Medicaid births annually.
- The company is actively pursuing broader coverage at the employer, plan, and state levels.
The following table summarizes key financial metrics that underpin the investment in these commercial and reimbursement channels as of the latest reported quarter in 2025.
| Metric | Value (Q3 2025) | Context |
| Revenue | $16,000 | Third quarter of 2025 |
| Selling, General & Administrative Expenses | $5.7 million | Third quarter of 2025 |
| Cash and Equivalents | $102.4 million | As of September 30, 2025 |
| Net Loss | $7.8 million | Third quarter of 2025 |
Digital and medical conference presence for physician and patient awareness.
- Continued engagement with the medical community included presenting health economics data at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe conference.
- A presentation by Dr. Brian Iriye was given at the inaugural Renaissance Conference: The Three Ages of the Woman.
- Sera Prognostics, Inc. was expecting to have a strong presence at the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Clinical & Scientific Meeting on May 16-18.
- The company is investing in targeted awareness initiatives, as reflected in the $5.7 million SG&A spend for Q3 2025.
Sera Prognostics, Inc. (SERA) - Canvas Business Model: Customer Segments
You're looking at the customer segments for Sera Prognostics, Inc. (SERA) as we close out 2025. The commercial strategy is clearly focused on demonstrating the economic value of the PreTRM® Test to the entities that pay for care, which then drives adoption by the clinicians who order the test. This is a classic payer-provider adoption dynamic, but with a clear, high-stakes clinical endpoint: premature birth.
The company's financial reality in Q3 2025-with trailing twelve-month revenue of $95K and cash reserves of approximately $102.4 million as of September 30, 2025-shows they are still in a heavy investment phase, making payer coverage the absolute priority for unlocking scale.
US Healthcare Payers (Commercial Insurers and Managed Medicaid plans)
Payers are the linchpin for Sera Prognostics, Inc. (SERA) right now. The focus is on proving the health economic benefits, especially the potential to reduce costs associated with preterm birth. Medicaid plans are a key target, representing what management views as approximately half of the market opportunity for the PreTRM® Test.
Here's a snapshot of payer engagement as of late 2025:
| Payer Type/Initiative | Status/Metric (Late 2025) | Financial/Volume Data Point |
|---|---|---|
| Medicaid Pilot Programs | Inaugural pilot launched in Nevada (Q3 2025) | Received a $100,000 prepayment from the Nevada pilot. |
| Total Payer Engagement | Engaging with payers across thirteen states | Multi-year contract in place with Elevance Health (which covers more than 10% of U.S. pregnancies annually). |
| Target Market Focus | Pursuing coverage at the employer, plan, and state levels | Discussions ongoing with several Medicaid plans across three states (as of Q1 2025). |
Securing broad coverage is the critical next step to unlocking value at scale, as noted by leadership.
Healthcare Providers, primarily OB/GYNs and MFM specialists
Providers are the gatekeepers who order the test based on clinical need and, increasingly, payer coverage. Sera Prognostics, Inc. (SERA) is cultivating interest through evidence dissemination.
- Attended the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Clinical & Scientific Meeting (May 16-18) to cultivate interest in the PreTRM test-and-treat paradigm.
- Presented health economics data at the International Society for Pharmarmacic Economics and Outcomes Research (ISPORE) Europe conference in Q3 2025.
- Presented PRIME study outcomes at the Renaissance conference in October 2025.
- The company is executing an integrated approach including physician education.
Pregnant women with asymptomatic, singleton pregnancies at 18-20 weeks gestation
This group represents the ultimate beneficiary and the population for whom the test is designed to provide individualized risk assessment. While a specific count of this segment targeted in 2025 isn't public, the clinical context is clear:
- The test provides pivotal information to enable more informed decision-making during pregnancy.
- Ten percent of all births in the U.S. are preterm.
- Traditional methods fail to detect approximately 80% of pregnancies that result in spontaneous preterm deliveries.
- The PRIME study demonstrated a 25% reduction in neonatal morbidity and mortality in the modified intent-to-treat population.
- The test supports a potential 18% reduction in neonatal hospital length of stay for high-risk cases.
Hospitals and health systems seeking to improve maternal and neonatal quality metrics
Hospitals and health systems are motivated by quality metrics, reducing readmissions, and managing the high costs associated with neonatal intensive care unit (NICU) stays.
- Partners recognize the potential to reduce NICU admissions by 20%.
- The value proposition centers on improving maternal and neonatal outcomes while significantly lowering costs driven by preterm birth.
- The company is focused on generating data on health economic benefits to support adoption by these systems.
Sera Prognostics, Inc. (SERA) - Canvas Business Model: Cost Structure
You're looking at the core expenditures Sera Prognostics, Inc. (SERA) is facing as it pushes its commercial strategy forward in late 2025. The cost structure is heavily weighted toward scaling the business and advancing the science.
The primary cost drivers for Sera Prognostics, Inc. in the third quarter of 2025 centered on expanding market reach and maintaining the scientific foundation. Total operating expenses for the period ending September 30, 2025, reached $9.0 million.
Here's how the major components of that spending broke down for Q3 2025:
- High Selling, General, and Administrative (SG&A) expenses for commercial expansion were reported at $5.7 million.
- Research and Development (R&D) costs for clinical studies and ongoing science were $3.3 million.
The remaining costs, which cover operating the CLIA-certified diagnostic laboratory, legal and regulatory compliance, and general corporate overhead, are implicitly covered within the total operating expenses, as the sum of the reported SG&A and R&D equals the total operating expense figure provided in the financial summaries. It's defintely a heavy lift to manage these fixed and semi-fixed costs while revenue generation is still ramping up.
Here is a quick look at the key Q3 2025 expense figures:
| Cost Category | Q3 2025 Amount (in thousands) |
| Selling, General, and Administrative (SG&A) | $5,700 |
| Research and Development (R&D) | $3,300 |
| Total Operating Expenses | $9,000 |
The R&D spend of $3.3 million in Q3 2025 was noted as lower than the prior year, primarily because the pivotal PRIME study completion reduced third-party analysis costs. This signals a shift in focus from large-scale trial execution to commercialization activities, which is reflected in the higher SG&A spend.
Costs associated with operating the CLIA-certified diagnostic laboratory are a necessary component of the Cost of Revenue and overhead, supporting the delivery of the PreTRM Test. Legal and regulatory costs for intellectual property protection and compliance with bodies like the FDA are ongoing risks that must be factored into the general corporate overhead, which is bundled into the SG&A line item.
- The investment in SG&A at $5.7 million reflects continued investment in targeted commercial activities.
- This commercial push includes strategic headcount additions to support market awareness ahead of key data publications.
- General corporate overhead and public company compliance costs are absorbed within the SG&A structure.
Finance: draft 13-week cash view by Friday.
Sera Prognostics, Inc. (SERA) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of Sera Prognostics, Inc. (SERA) as of late 2025, and honestly, the picture is one of early-stage commercialization where upfront payments and pilot programs are temporarily overshadowing test-by-test revenue. The core business model relies on getting the PreTRM Test covered by payers, which is where the real money is set to flow.
Revenue from the PreTRM test, currently very low (Q3 2025: $16,000). This figure represents the actual recognized revenue from tests processed during the third quarter of 2025, a decrease from $29,000 reported in the same period of 2024. It shows the current state of direct test utilization revenue before broader insurance adoption kicks in.
Here's a quick look at the key financial metrics impacting revenue recognition for Q3 2025:
| Metric | Amount (Q3 2025) |
| Recognized Revenue (PreTRM Test) | $16,000 |
| Deferred Revenue Increase (Prepayments) | $100,000 |
| Cash, Cash Equivalents, Securities (as of 9/30/2025) | Approximately $102.4 million |
Reimbursement payments from commercial and government payers upon coverage adoption. This is the primary long-term revenue driver. Sera Prognostics is actively engaging with payers across thirteen states, signaling significant commercial groundwork. The potential here is substantial, considering Medicaid already covers an estimated 40% of US births. Landing these coverage decisions is what transforms the low current revenue into scalable income.
Deferred revenue from upfront payments for Medicaid pilot programs. You see a clear example of this in the Q3 2025 results. The company received a $100,000 prepayment from the first Medicaid pilot, which is located in Nevada. This prepayment immediately increased the deferred revenue balance by $100,000 as of September 30, 2025. This cash is recognized as revenue only as the service is delivered over the contract period, so it's a leading indicator of future recognized revenue.
Potential future revenue from a pipeline of other pregnancy diagnostic tests. While the PreTRM Test is the current revenue source, the business model anticipates future streams from a robust pipeline. This pipeline focuses on other complications of pregnancy, which could diversify revenue beyond just preterm birth risk prediction. The current cash position of approximately $102.4 million as of September 30, 2025, is intended to fund operations through significant adoption milestones, which includes advancing this pipeline.
The current revenue streams are characterized by:
- Reliance on PreTRM Test for all current recognized revenue.
- Significant non-recognized revenue sitting in deferred balances.
- Active payer negotiations in multiple states.
- A pipeline aimed at future market expansion.
Finance: draft 13-week cash view by Friday.
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