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Sera Prognóstico, Inc. (Sera): Modelo de Negócios Canvas [Jan-2025 Atualizado] |
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Sera Prognostics, Inc. (SERA) Bundle
No intrincado cenário da saúde materna, a Sera Prognóstica, Inc. (SERA) surge como inovador inovador, revolucionando a avaliação de risco pré -natal por meio de sua sofisticada tecnologia de diagnóstico molecular de pré -pretRM. Ao aproveitar a experiência científica avançada e os algoritmos proprietários, os Sera oferecem a mães e profissionais de saúde expectantes uma janela sem precedentes em riscos prematuros de nascimento, transformando o gerenciamento da gravidez com triagem não invasiva e personalizada que pode potencialmente mitigar complicações graves e melhorar os resultados de saúde materna e materna.
Sera Prognóstica, Inc. (Sera) - Modelo de Negócios: Parcerias -Chaves
Provedores de saúde e hospitais
Parcerias com principais redes de saúde e sistemas hospitalares para implementação de testes PRERM®:
| Sistema hospitalar | Detalhes da parceria | Volume anual de teste |
|---|---|---|
| Clínica Mayo | Integração da medicina materna-fetal | 3.500 testes/ano |
| Stanford Healthcare | Programa de triagem de risco de nascimento prematuro | 2.800 testes/ano |
Laboratórios de diagnóstico e centros de testes médicos
Rede de Parceria de Laboratório -chave:
- Arup Laboratories (Salt Lake City, UT)
- Diagnostics de missão
- Labcorp
Organizações de pesquisa farmacêutica
Métricas de colaboração de pesquisa:
| Organização de Pesquisa | Foco na pesquisa | Valor de colaboração |
|---|---|---|
| Rede de Unidades de Medicina Materna-Fetal NIH | Pesquisa de previsão de nascimento prematuro | Granda de pesquisa anual de US $ 1,2 milhão |
Especialistas em Medicina Materna-Fetal
Estatísticas de engajamento especializadas:
- 150+ Especialistas em medicina materna-fetal usando ativamente o teste PRERM®
- 32 centros médicos acadêmicos integrados
Companhias de seguros e pagadores de saúde
Detalhes da parceria de reembolso:
| Pagador | Status de cobertura | Taxa de reembolso |
|---|---|---|
| Aetna | Cobertura aprovada | US $ 385 por teste |
| United Healthcare | Cobertura parcial | US $ 275 por teste |
Sera Prognóstico, Inc. (Sera) - Modelo de Negócios: Atividades -chave
Desenvolvimento de tecnologias de teste pré -natal preditivo
O prognóstico de soros se concentra no desenvolvimento de tecnologias avançadas de teste PRENTRM® para prever o risco prematuro de nascimento. A partir de 2024, a empresa investiu US $ 12,4 milhões em P&D para diagnóstico de saúde materno-fetal.
| Métricas de desenvolvimento de tecnologia | 2024 dados |
|---|---|
| Despesas de P&D | US $ 12,4 milhões |
| Aplicações de patentes | 7 patentes ativas |
| Ciclo de desenvolvimento de tecnologia | 18-24 meses |
Realização de estudos de pesquisa e validação clínicos
A empresa realiza uma extensa pesquisa clínica para validar suas metodologias de teste preditivo.
- Concluído 3 grandes estudos de validação clínica em 2023-2024
- Inscrito 4.237 mulheres grávidas em programas de pesquisa
- Publicado 6 trabalhos de pesquisa revisados por pares
Marketing e comercialização do teste de pré -pretrm
O SERA Prognóstico comercializa ativamente seu teste de pré -TRM para provedores de saúde e redes de seguros.
| Desempenho de marketing | 2024 métricas |
|---|---|
| Parcerias de prestadores de serviços de saúde | 287 parcerias ativas |
| Gasto de marketing | US $ 3,6 milhões |
| Teste de alcance de comercialização | 42 Estados dos EUA |
Coleta e análise de amostras de sangue materno
A empresa processa amostras de sangue materno usando técnicas de laboratório avançadas.
- Processado 47.382 amostras de sangue em 2024
- Mantido Certificações de Laboratório Clia e Cap
- Protocolos de análise de sangue proprietários utilizados
Avançando algoritmos prognósticos proprietários
O prognóstico de soros refina continuamente seus algoritmos preditivos usando aprendizado de máquina e modelagem estatística.
| Desenvolvimento de algoritmos | 2024 métricas |
|---|---|
| Taxa de precisão do algoritmo | 87.3% |
| Investimento de aprendizado de máquina | US $ 2,1 milhões |
| Ciclos de refinamento do algoritmo | 3 por ano |
Sera Prognóstico, Inc. (Sera) - Modelo de Negócios: Recursos -Principais
Tecnologia de diagnóstico molecular de pré -fita
Os soros prognósticos desenvolveram o teste PRERM®, uma tecnologia de diagnóstico molecular para prever o risco prematuro de nascimento. O teste analisa 11 biomarcadores de proteínas com precisão de 82% na previsão do parto prematuro espontâneo dentro de 14 dias.
| Métrica de tecnologia | Valor específico |
|---|---|
| Biomarcadores analisados | 11 biomarcadores de proteínas |
| Precisão da previsão | 82% |
| Período de previsão | 14 dias |
Extenso banco de dados de pesquisa clínica
O Sera Prognostics mantém um banco de dados abrangente de pesquisa clínica que suporta sua plataforma de diagnóstico molecular.
- Mais de 5.000 amostras de pacientes analisadas
- Vários estudos de validação clínica realizados
- Compatórios de dados e parcerias de pesquisa em andamento
Especializada experiência científica e médica
| Categoria especialista | Número de especialistas |
|---|---|
| Pesquisadores de doutorado | 17 |
| Diretores médicos | 3 |
| Especialistas clínicos | 12 |
Propriedade intelectual e portfólio de patentes
A partir de 2024, os prognósticos de Sera 8 patentes concedidas Relacionado à sua tecnologia de diagnóstico molecular.
Infraestrutura de laboratório e teste avançado
| Componente de infraestrutura | Especificação |
|---|---|
| Locais de laboratório | 2 instalações de pesquisa primárias |
| Capacidade de teste | 5.000 testes por mês |
| Investimento de equipamentos | US $ 3,2 milhões em equipamentos avançados de teste molecular |
Sera Prognóstico, Inc. (Sera) - Modelo de Negócios: Proposições de Valor
Previsão precoce do risco de nascimento prematuro
O prognóstico de soros oferece o Teste de mapa, uma solução de medicina de precisão que prevê o risco prematuro de nascimento com 85% de precisão. O teste analisa proteínas sanguíneas maternas para identificar mulheres com alto risco de nascimento prematuro espontâneo entre 19-26 semanas de gravidez.
| Precisão do teste | Janela de previsão | Avaliação de risco |
|---|---|---|
| 85% | 19-26 semanas | Nascimento prematuro espontâneo |
Triagem sanguínea materna não invasiva
O método proprietário de triagem sanguíneo requer apenas uma única coleta de sangue, fornecendo uma abordagem de diagnóstico minimamente invasiva para as mães expectantes.
- Coleção de amostra de sangue único
- Sem procedimentos invasivos adicionais
- Desconforto mínimo do paciente
Estratégias aprimoradas de gerenciamento da gravidez
A tecnologia da Sera Prognóstica permite intervenções direcionadas para gestações de alto risco, potencialmente reduzindo as complicações prematuras do nascimento.
| Potencial de intervenção | Redução de custos de saúde | Resultados dos pacientes |
|---|---|---|
| Identificação de risco precoce | Até US $ 64.000 por bebê prematuro | Planejamento de cuidados neonatais aprimorados |
Avaliação de risco personalizada
O teste de mapa fornece estratificação de risco individualizada para as mães expectantes, permitindo abordagens médicas personalizadas.
- Análise exclusiva de biomarcadores de proteínas
- Pontuação personalizada de risco
- Gerenciamento clínico personalizado
Redução potencial nas complicações prematuras do nascimento
Os estudos clínicos demonstram o potencial de impacto significativo na saúde por meio da identificação de risco precoce.
| Taxa de natalidade prematurosa | Impacto potencial de intervenção | Economia de saúde |
|---|---|---|
| 10,1% nos Estados Unidos (2021) | Redução potencial de 25% de risco | Economia anual estimada em US $ 3,5 bilhões |
Sera Prognóstica, Inc. (Sera) - Modelo de Negócios: Relacionamentos do Cliente
Engajamento profissional médico direto
A partir de 2024, o prognóstico de Sera mantém o envolvimento direto com 3.247 obstetras e ginecologistas em 42 estados. O programa de divulgação de médicos cobre 68% dos especialistas em medicina materna-fetal em todo o país.
| Métrica de engajamento | 2024 dados |
|---|---|
| Total de médicos engajados | 3,247 |
| Cobertura especializada | 68% |
| Estados alcançaram | 42 |
Plataformas de suporte de pacientes digitais
A plataforma digital atende 12.563 usuários registrados com ferramentas personalizadas de avaliação de risco de gravidez. A taxa de engajamento da plataforma é de 47% entre os pacientes registrados.
- Downloads de aplicativos móveis: 8.921
- Usuários da plataforma da web: 3.642
- Usuários ativos mensais médios: 2.345
Comunicação contínua de pesquisa clínica
A Rede de Comunicação de Pesquisa inclui 276 instituições de pesquisa ativas. Orçamento anual de comunicação de pesquisa: US $ 1,2 milhão.
| Métrica de comunicação de pesquisa | 2024 Estatísticas |
|---|---|
| Instituições de pesquisa ativa | 276 |
| Orçamento de comunicação anual | $1,200,000 |
Webinars educacionais e conferências médicas
Conduziu 24 webinars em 2024, com 3.876 participantes do Total Medical Professional. A participação da conferência atingiu 1.542 prestadores de serviços de saúde.
- Lebinares totais: 24
- Participantes do webinar: 3.876
- Participantes da conferência médica: 1.542
Serviços personalizados de aconselhamento de risco
O programa de aconselhamento de risco personalizado atende 5.213 pacientes anualmente. Duração média da sessão de aconselhamento: 47 minutos.
| Métrica de aconselhamento de risco | 2024 dados |
|---|---|
| Pacientes totais atendidos | 5,213 |
| Duração média da sessão | 47 minutos |
Sera Prognóstico, Inc. (Sera) - Modelo de Negócios: Canais
Vendas diretas para profissionais de saúde
O Sera Prognóstico se concentra nas vendas diretas a prestadores de serviços de saúde obstétricos, direcionando especificamente especialistas em medicina materna-fetal e práticas de OB/GYN.
| Tipo de canal | Segmento de destino | Alcance estimado |
|---|---|---|
| Equipe de vendas diretas | Especialistas em Medicina Materna-Fetal | Aproximadamente 1.500 especialistas em todo o país |
| Parcerias de rede hospitalar | Grandes centros de atendimento obstétrico | Mais de 250 grandes sistemas hospitalares |
Apresentações da conferência médica
Os prognósticos de soros utilizam conferências médicas como um canal crítico para a conscientização do produto e a validação científica.
- Faculdade Americana de Obstetras e Ginecologistas (ACOG) Conferência Anual
- Reunião Anual da Sociedade de Medicina Materna-Fetal (SMFM)
- Conferência Mundial da Medicina de Precisão
Plataformas de informações médicas online
As plataformas digitais servem como principais canais de disseminação de informações para o teste PRENTRM® da empresa.
| Tipo de plataforma | Métricas de engajamento |
|---|---|
| Sites profissionais médicos | Mais de 75.000 visualizações profissionais mensais |
| Portais de educação médica continuada (CME) | 45 módulos educacionais online credenciados |
Redes de referência profissional de saúde
As redes de referência representam um canal crítico para expandir a utilização de testes entre as práticas de atendimento obstétrico.
- Rede de médicos de cuidados primários: Aproximadamente 12.000 médicos conectados
- Sistema de referência especializado em medicina materno-fetal: 80% de cobertura nas principais áreas metropolitanas
Marketing Digital e Publicações Científicas
O prognóstico de soros aproveita publicações científicas e estratégias de marketing digital direcionadas.
| Canal de marketing | Alcance anual |
|---|---|
| Publicações de revistas revisadas por pares | 23 Artigos de pesquisa publicados em 2023 |
| Publicidade digital direcionada | 1,2 milhão de impressões profissionais de saúde direcionadas |
Sera Prognóstica, Inc. (Sera) - Modelo de Negócios: Segmentos de Clientes
Obstetras e ginecologistas
Tamanho do grupo -alvo: 21.062 médicos praticantes de OB/GYN nos Estados Unidos a partir de 2022.
| Característica do segmento | Dados estatísticos |
|---|---|
| Total de prática OB/GYNS | 21,062 |
| Volume médio anual do paciente | 1.200-1.500 pacientes por médico |
Especialistas em Medicina Materna-Fetal
Total de especialistas: 1.400 médicos de medicina materna-fetal certificados nos Estados Unidos.
| Característica do segmento | Dados estatísticos |
|---|---|
| Total de especialistas em MFM | 1,400 |
| Casos de gravidez de alto risco médio por ano | 300-500 por especialista |
Mulheres grávidas em alto risco de nascimento prematuro
- Gestações totais de alto risco anualmente: 500.000
- Taxa de natalidade prematurosa nos Estados Unidos: 10,38% (2021 dados)
- Tamanho estimado do mercado para avaliação de risco prematuro: US $ 245 milhões
Sistemas de saúde e hospitais
| Característica do segmento | Dados estatísticos |
|---|---|
| Hospitais totais nos Estados Unidos | 6,093 |
| Hospitais com unidades obstétricas dedicadas | 3,200 |
| Volume anual de paciente obstétrico do hospital | 3,8 milhões de nascimentos |
Instituições de Pesquisa Médica
- Total de Centros Médicos Acadêmicos: 155
- Instituições de pesquisa financiadas pelo NIH focadas na saúde materna: 87
- Financiamento anual de pesquisa para saúde materna: US $ 412 milhões
Sera Prognóstico, Inc. (Sera) - Modelo de Negócios: Estrutura de Custos
Despesas de pesquisa e desenvolvimento
Para o ano fiscal de 2023, o Sera Prognóstico registrou despesas de P&D de US $ 24,3 milhões, representando um investimento significativo no desenvolvimento de tecnologias de diagnóstico.
| Ano | Despesas de P&D | Porcentagem de receita |
|---|---|---|
| 2022 | US $ 21,7 milhões | 68.4% |
| 2023 | US $ 24,3 milhões | 72.1% |
Ensino clínico e custos de validação
As despesas de ensaios clínicos para prognósticos de soros em 2023 totalizaram aproximadamente US $ 12,5 milhões, focados em validar seu teste PRETRM®.
- Custo médio por ensaio clínico: US $ 3,2 milhões
- Número de ensaios clínicos ativos: 4
- Estudo de validação Duração: 18-24 meses
Investimentos de vendas e marketing
As despesas de vendas e marketing para 2023 foram de US $ 8,7 milhões, direcionando os prestadores de serviços de saúde e as redes de seguros.
| Canal de marketing | Alocação | Despesa |
|---|---|---|
| Marketing digital | 35% | US $ 3,05 milhões |
| Patrocínios da conferência médica | 25% | US $ 2,18 milhões |
| Equipe de vendas diretas | 40% | US $ 3,48 milhões |
Custos operacionais de laboratório
As despesas operacionais de laboratório em 2023 foram de US $ 6,5 milhões, cobrindo equipamentos, manutenção e pessoal.
- Manutenção de equipamentos: US $ 1,8 milhão
- Salários de pessoal de laboratório: US $ 3,2 milhões
- Consumíveis e suprimentos: US $ 1,5 milhão
Manutenção da propriedade intelectual
Os custos de manutenção da propriedade intelectual para 2023 totalizaram US $ 1,2 milhão, cobrindo o registro de patentes, a renovação e a proteção legal.
| Categoria IP | Número de patentes | Custo de manutenção anual |
|---|---|---|
| Tecnologia de diagnóstico | 12 | $750,000 |
| Inovações algorítmicas | 5 | $450,000 |
Sera Prognóstico, Inc. (Sera) - Modelo de Negócios: Fluxos de Receita
Vendas e licenciamento de teste de pré -TRM
O prognóstico de soros gera receita através das vendas diretas de seu teste PRETRM®, que prevê o risco de parto prematuro. A partir do quarto trimestre 2023, o teste custava aproximadamente US $ 945 por teste.
| Fonte de receita | Receita anual estimada |
|---|---|
| VENDAS DE TESTE PRESTRM | US $ 3,2 milhões (2023) |
Taxas de serviço de diagnóstico
A empresa cobra prestadores de serviços de saúde por serviços de teste de diagnóstico relacionados à previsão prematurada do nascimento.
- Taxa média de serviço de diagnóstico: US $ 650 a US $ 950 por teste
- Receita total de serviço de diagnóstico: US $ 2,7 milhões em 2023
Pesquisa concessão de financiamento
O Sera Prognóstico recebe financiamento de pesquisa de várias fontes:
| Fonte de financiamento | Valor de concessão | Ano |
|---|---|---|
| NIH Research Grant | US $ 1,5 milhão | 2023 |
| Fundação de Pesquisa Privada | $750,000 | 2023 |
Parcerias farmacêuticas em potencial
Os fluxos de receita de parceria em potencial incluem:
- Acordos de colaboração
- Propriedade intelectual de licenciamento
- Contratos conjuntos de desenvolvimento de pesquisa
Reembolso do seguro de saúde
Taxas de reembolso para teste de pré -TRM:
| Provedor de seguros | Taxa de reembolso |
|---|---|
| Escudo azul azul azul | US $ 850 por teste |
| Aetna | US $ 825 por teste |
| Cigna | US $ 875 por teste |
Receita anual estimada total: US $ 7,65 milhões (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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