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SERA PROGNOSTICS, Inc. (SERA): Business Model Canvas [Jan-2025 Mis à jour] |
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Sera Prognostics, Inc. (SERA) Bundle
Dans le paysage complexe des soins de santé maternelle, Sera Prognostics, Inc. (SERA) émerge comme un innovateur révolutionnaire, révolutionnant l'évaluation des risques prénatals par sa technologie de diagnostic moléculaire prérm sophistiquée. En exploitant une expertise scientifique avancée et des algorithmes propriétaires, Sera propose aux femmes enceintes et aux professionnels de la santé une fenêtre sans précédent sur les risques de naissance prématurés, transformant la gestion de la grossesse avec un dépistage personnalisé non invasif qui pourrait potentiellement atténuer les complications et améliorer les résultats de la santé des materneaux et des nourrissons.
SERA PROGNOSTICS, Inc. (SERA) - Modèle commercial: partenariats clés
Fournisseurs de soins de santé et hôpitaux
Partenariats avec les principaux réseaux de soins de santé et systèmes hospitaliers pour la mise en œuvre du test Pretrm®:
| Système hospitalier | Détails du partenariat | Volume de test annuel |
|---|---|---|
| Clinique de mayo | Intégration de la médecine maternelle-fœtale | 3 500 tests / an |
| Stanford Healthcare | Programme de dépistage des risques de naissance prématurés | 2 800 tests / an |
Laboratoires de diagnostic et centres de tests médicaux
Réseau clé de partenariat de laboratoire:
- ARUP Laboratories (Salt Lake City, UT)
- Diagnostics de quête
- Laborp
Organisations de recherche pharmaceutique
Métriques de collaboration de recherche:
| Organisation de recherche | Focus de recherche | Valeur de collaboration |
|---|---|---|
| NIH NIH MATERNAL-FETAL MEDICINE UNITS NETWER | Recherche de prédiction des naissances prématurées | Subvention de recherche annuelle de 1,2 million de dollars |
Spécialistes de la médecine fœtale maternelle
Statistiques de l'engagement spécialisés:
- 150+ spécialistes de la médecine maternelle-fœtale utilisant activement le test Pretrm®
- 32 centres médicaux académiques intégrés
Compagnies d'assurance et payeurs de soins de santé
Détails du partenariat de remboursement:
| Payeur | Statut de couverture | Taux de remboursement |
|---|---|---|
| Aetna | Couverture approuvée | 385 $ par test |
| United Healthcare | Couverture partielle | 275 $ par test |
SERA PROGNOSTICS, Inc. (SERA) - Modèle d'entreprise: Activités clés
Développer des technologies de test prénatal prédictif
Les pronostiques de sérums se concentrent sur le développement des technologies de test pré-TRM® avancées pour prédire le risque de naissance prématuré. En 2024, la société a investi 12,4 millions de dollars en R&D pour les diagnostics de santé maternelle-fœtale.
| Métriques de développement technologique | 2024 données |
|---|---|
| Dépenses de R&D | 12,4 millions de dollars |
| Demandes de brevet | 7 brevets actifs |
| Cycle de développement de la technologie | 18-24 mois |
Mener des études de recherche et de validation cliniques
La société mène une recherche clinique approfondie pour valider ses méthodologies de test prédictives.
- Terminé 3 grandes études de validation clinique en 2023-2024
- Inscrit 4 237 femmes enceintes dans des programmes de recherche
- Publié 6 articles de recherche évalués par des pairs
Marketing et commercialisation du test de prétram
Les pronostiques de sérums commercialisent activement son test de pré-TRM aux prestataires de soins de santé et aux réseaux d'assurance.
| Performance marketing | 2024 mesures |
|---|---|
| Partenariats des fournisseurs de soins de santé | 287 partenariats actifs |
| Dépenses de marketing | 3,6 millions de dollars |
| Tester la portée de la commercialisation | 42 États américains |
Collectionner et analyser des échantillons de sang maternel
L'entreprise traite des échantillons de sang maternel à l'aide de techniques de laboratoire avancées.
- Traité 47 382 échantillons de sang en 2024
- Certifications de laboratoire Clia et CAP entretenues
- Utilisé des protocoles d'analyse du sang propriétaire
Algorithmes pronostiques propriétaires
Les pronostiques sérums affinent en permanence ses algorithmes prédictifs en utilisant l'apprentissage automatique et la modélisation statistique.
| Développement d'algorithme | 2024 mesures |
|---|---|
| Taux de précision de l'algorithme | 87.3% |
| Investissement d'apprentissage automatique | 2,1 millions de dollars |
| Cycles de raffinement algorithme | 3 par an |
SERA PROGNOSTICS, Inc. (Sera) - Modèle d'entreprise: Ressources clés
Technologie de diagnostic moléculaire de Pretrm propriétaire
Les pronostiques de sérum ont développé le test Pretrm®, une technologie de diagnostic moléculaire pour prédire le risque de naissance prématuré. Le test analyse 11 biomarqueurs protéiques avec une précision de 82% pour prédire la naissance spontanée prématurée dans les 14 jours.
| Métrique technologique | Valeur spécifique |
|---|---|
| Biomarqueurs analysés | 11 biomarqueurs protéiques |
| Précision de prédiction | 82% |
| Du délai de prédiction | 14 jours |
Base de données de recherche clinique étendue
SERA PROGNOSTIQUES maintient une base de données de recherche clinique complète soutenant sa plate-forme de diagnostic moléculaire.
- Plus de 5 000 échantillons de patients analysés
- Plusieurs études de validation clinique menées
- COLLECTION DES DONNÉES ET PARTENARIES DE RECHERCHE DE DONNÉES
Expertise scientifique et médicale spécialisée
| Catégorie d'experts | Nombre de spécialistes |
|---|---|
| Chercheurs de doctorat | 17 |
| Directeurs médicaux | 3 |
| Spécialistes cliniques | 12 |
Propriété intellectuelle et portefeuille de brevets
Depuis 2024, les pronostiques de sérum 8 brevets accordés lié à sa technologie de diagnostic moléculaire.
Infrastructure avancée de laboratoire et d'essai
| Composant d'infrastructure | Spécification |
|---|---|
| Lieux de laboratoire | 2 installations de recherche primaires |
| Capacité d'essai | 5 000 tests par mois |
| Investissement de l'équipement | 3,2 millions de dollars en équipement de test moléculaire avancé |
Sera Prognostics, Inc. (Sera) - Modèle d'entreprise: propositions de valeur
Prédiction précoce du risque de naissance prématuré
SERA PROGNOSTIQUES propose le Test de carte, une solution de médecine de précision qui prédit un risque de naissance prématuré avec une précision de 85%. Le test analyse les protéines sanguines maternelles pour identifier les femmes à haut risque de naissances prématurées spontanées entre 19 à 26 semaines de grossesse.
| Précision de test | Fenêtre de prédiction | L'évaluation des risques |
|---|---|---|
| 85% | 19-26 semaines | Naissance prématurée spontanée |
Dépistage sanguin maternel non invasif
La méthode de dépistage du sang propriétaire ne nécessite qu'un seul prélèvement sanguin, offrant une approche diagnostique mini-invasive pour les femmes enceintes.
- Collection d'échantillons de sang unique
- Aucune procédure invasive supplémentaire
- Inconfort minimal des patients
Amélioration des stratégies de gestion de la grossesse
La technologie des sérums de pronostics permet des interventions ciblées pour les grossesses à haut risque, ce qui pourrait réduire les complications de naissance prématurées.
| Potentiel d'intervention | Réduction des coûts des soins de santé | Résultats des patients |
|---|---|---|
| Identification précoce des risques | Jusqu'à 64 000 $ par nourrisson prématuré | Amélioration de la planification des soins néonatals |
Évaluation des risques personnalisés
Le test de la carte fournit une stratification des risques individualisée pour les femmes enceintes, permettant des approches médicales personnalisées.
- Analyse unique des biomarqueurs protéiques
- Score de risque personnalisé
- Gestion clinique sur mesure
Réduction potentielle des complications de naissance prématurées
Les études cliniques démontrent le potentiel d'impact significatif des soins de santé grâce à une identification précoce des risques.
| Taux de naissance prématuré | Impact potentiel de l'intervention | Économies de soins de santé |
|---|---|---|
| 10,1% aux États-Unis (2021) | Réduction potentielle de 25% des risques | Économies annuelles estimées de 3,5 milliards de dollars |
SERA PROGNOSTICS, Inc. (SERA) - Modèle d'entreprise: relations clients
Engagement professionnel médical direct
En 2024, les pronostiques de sérums maintiennent un engagement direct avec 3 247 obstétriciens et gynécologues dans 42 États. Le programme de sensibilisation des médecins couvre 68% des spécialistes de la médecine maternelle-fœtale à l'échelle nationale.
| Métrique de l'engagement | 2024 données |
|---|---|
| Total des médecins engagés | 3,247 |
| Couverture spécialisée | 68% |
| États atteints | 42 |
Plates-formes de support des patients numériques
La plate-forme numérique dessert 12 563 utilisateurs enregistrés avec des outils personnalisés d'évaluation des risques de grossesse. Le taux d'engagement des plateformes est de 47% chez les patients enregistrés.
- Téléchargements d'applications mobiles: 8 921
- Utilisateurs de la plate-forme Web: 3 642
- Utilisateurs actifs mensuels moyens: 2 345
Communication de recherche clinique continue
Le réseau de communication de recherche comprend 276 institutions de recherche actives. Budget de communication de recherche annuelle: 1,2 million de dollars.
| Métrique de communication de recherche | 2024 statistiques |
|---|---|
| Institutions de recherche actives | 276 |
| Budget de communication annuel | $1,200,000 |
Webinaires éducatifs et conférences médicales
A mené 24 webinaires en 2024, avec 3 876 participants au plus professionnel en médecine. La participation de la conférence a atteint 1 542 prestataires de soins de santé.
- Total des webinaires: 24
- Participants du webinaire: 3 876
- Participants à la conférence médicale: 1 542
Services de conseil à risque personnalisés
Le programme de counseling à risque personnalisé dessert 5 213 patients par an. Durée moyenne de la session de conseil: 47 minutes.
| Métrique de conseil à risque | 2024 données |
|---|---|
| Les patients totaux ont servi | 5,213 |
| Durée moyenne de la session | 47 minutes |
SERA PROGNOSTICS, Inc. (Sera) - Modèle d'entreprise: canaux
Ventes directes aux prestataires de soins de santé
SERA PROGNOSTICS se concentre sur les ventes directes des prestataires de soins de santé obstétricaux, ciblant spécifiquement les spécialistes de la médecine maternelle-fœtale et les pratiques OB / GYN.
| Type de canal | Segment cible | Portée estimée |
|---|---|---|
| Équipe de vente directe | Spécialistes de la médecine fœtale maternelle | Environ 1 500 spécialistes à l'échelle nationale |
| Partenariats de réseaux hospitaliers | Grands centres de soins obstétricaux | Plus de 250 grands systèmes hospitaliers |
Présentations de la conférence médicale
Les pronostiques de sérum utilisent des conférences médicales comme canal critique pour la sensibilisation des produits et la validation scientifique.
- Conférence annuelle de l'American College of Obstetriciens and Gynecologists (ACOG)
- Réunion annuelle de la Société pour la médecine maternelle-fœtale (SMFM)
- Conférence du monde de la médecine de précision
Plateformes d'information médicale en ligne
Les plates-formes numériques servent de canaux de dissémination d'informations clés pour le test Pretrm® de l'entreprise.
| Type de plate-forme | Métriques d'engagement |
|---|---|
| Sites Web professionnels médicaux | Plus de 75 000 vues professionnelles mensuelles |
| Portails de formation médicale continue (CME) | 45 modules éducatifs en ligne accrédités |
Réseaux de référence professionnels de la santé
Les réseaux de référence représentent un canal critique pour l'expansion de l'utilisation des tests entre les pratiques de soins obstétricales.
- Réseau de médecins de soins primaires: Environ 12 000 médecins connectés
- Système de référence spécialisé en médecine maternelle-fœtale: Couverture de 80% dans les grandes zones métropolitaines
Marketing numérique et publications scientifiques
SERA PROGNOSTICS tire parti des publications scientifiques et des stratégies de marketing numérique ciblées.
| Canal de marketing | Portée annuelle |
|---|---|
| Publications de journal évaluées par des pairs | 23 articles de recherche publiés en 2023 |
| Publicité numérique ciblée | 1,2 million d'impressions professionnelles de la santé ciblées |
SERA PROGNOSTICS, Inc. (SERA) - Modèle d'entreprise: segments de clientèle
Obstétriciens et gynécologues
Taille du groupe cible: 21 062 Physiciens de l'OB / GYN aux États-Unis à partir de 2022.
| Caractéristique du segment | Données statistiques |
|---|---|
| Total pratiquant OB / Gyns | 21,062 |
| Volume annuel moyen des patients | 1 200-1,500 patients par médecin |
Spécialistes de la médecine fœtale maternelle
Spécialistes totaux: 1 400 médecins de médecine materne-fœtale certifiés aux conseils aux États-Unis.
| Caractéristique du segment | Données statistiques |
|---|---|
| Spécialistes du MFM total | 1,400 |
| Cas de grossesse moyenne à haut risque par an | 300-500 par spécialiste |
Les femmes enceintes à haut risque d'accouchement prématuré
- Total des grossesses à haut risque par an: 500 000
- Taux de natalité prématuré aux États-Unis: 10,38% (2021 données)
- Taille estimée du marché pour l'évaluation des risques de naissance prématurée: 245 millions de dollars
Systèmes de soins de santé et hôpitaux
| Caractéristique du segment | Données statistiques |
|---|---|
| Total des hôpitaux aux États-Unis | 6,093 |
| Hôpitaux avec des unités obstétricales dédiées | 3,200 |
| Volume annuel de patient obstétrical à l'hôpital | 3,8 millions de naissances |
Institutions de recherche médicale
- Total des centres médicaux académiques: 155
- Institutions de recherche financées par les NIH axées sur la santé maternelle: 87
- Financement de la recherche annuelle pour la santé maternelle: 412 millions de dollars
Sera Prognostics, Inc. (Sera) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice 2023, Sera Prognostics a déclaré des dépenses de R&D de 24,3 millions de dollars, ce qui représente un investissement important dans le développement de technologies de diagnostic.
| Année | Dépenses de R&D | Pourcentage de revenus |
|---|---|---|
| 2022 | 21,7 millions de dollars | 68.4% |
| 2023 | 24,3 millions de dollars | 72.1% |
Essais cliniques et coûts de validation
Les dépenses d'essais cliniques pour les pronostiques de sérum en 2023 ont totalisé environ 12,5 millions de dollars, axée sur la validation de leur test Pretrm®.
- Coût moyen par essai clinique: 3,2 millions de dollars
- Nombre d'essais cliniques actifs: 4
- Durée de l'étude de validation: 18-24 mois
Investissements de vente et de marketing
Les dépenses de vente et de marketing pour 2023 étaient de 8,7 millions de dollars, ciblant les prestataires de soins de santé et les réseaux d'assurance.
| Canal de marketing | Allocation | Frais |
|---|---|---|
| Marketing numérique | 35% | 3,05 millions de dollars |
| Commanditaires de la conférence médicale | 25% | 2,18 millions de dollars |
| Équipe de vente directe | 40% | 3,48 millions de dollars |
Coûts opérationnels de laboratoire
Les dépenses opérationnelles en laboratoire en 2023 étaient de 6,5 millions de dollars, couvrant l'équipement, l'entretien et le personnel.
- Entretien de l'équipement: 1,8 million de dollars
- Salaires du personnel de laboratoire: 3,2 millions de dollars
- Consommables et fournitures: 1,5 million de dollars
Maintenance de la propriété intellectuelle
Les coûts de maintenance de la propriété intellectuelle pour 2023 s'élevaient à 1,2 million de dollars, couvrant le dépôt de brevets, le renouvellement et la protection juridique.
| Catégorie IP | Nombre de brevets | Coût de maintenance annuel |
|---|---|---|
| Technologie de diagnostic | 12 | $750,000 |
| Innovations algorithmiques | 5 | $450,000 |
SERA PROGNOSTICS, Inc. (SERA) - Modèle d'entreprise: sources de revenus
Ventes et licences de test de prérm
Les pronostiques de sérums génèrent des revenus grâce aux ventes directes de son test Pretrm®, qui prédit le risque d'accouchement prématuré. Au quatrième trimestre 2023, le test était au prix d'environ 945 $ par test.
| Source de revenus | Revenus annuels estimés |
|---|---|
| Ventes de tests de prérm | 3,2 millions de dollars (2023) |
Frais de service de diagnostic
La société facture des prestataires de soins de santé pour les services de test de diagnostic liés à la prédiction des naissances prématurées.
- Frais de service de diagnostic moyen: 650 $ - 950 $ par test
- Revenus de services de diagnostic total: 2,7 millions de dollars en 2023
Financement de la subvention de la recherche
SERA PROGNOSTICS reçoit le financement de la recherche de diverses sources:
| Source de financement | Montant d'octroi | Année |
|---|---|---|
| Subvention de recherche NIH | 1,5 million de dollars | 2023 |
| Fondation de recherche privée | $750,000 | 2023 |
Partenariats pharmaceutiques potentiels
Les sources de revenus potentiels de partenariat comprennent:
- Accords de collaboration
- Licence de propriété intellectuelle
- Contrats de développement de recherche conjointe
Remboursement de l'assurance des soins de santé
Tarifs de remboursement pour le test de pré-TRM:
| Assureur | Taux de remboursement |
|---|---|
| Blue Cross Blue Shield | 850 $ par test |
| Aetna | 825 $ par test |
| Cigna | 875 $ par test |
Revenu annuel total estimé: 7,65 millions de dollars (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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