OnCocyte Corporation (OCX): Canvas du modèle d'entreprise [Jan-2025 Mise à jour]

Dans le paysage rapide de l'oncologie de précision, Oncocyte Corporation (OCX) émerge comme une force pionnière, transformant le diagnostic du cancer par le biais de technologies de test moléculaires innovantes. En pontant stratégiquement les recherches de pointe, les plateformes de diagnostic avancées et les partenariats collaboratifs, OCX redéfinit la façon dont les prestataires de soins de santé détectent, comprennent et potentiellement intervenir dans la progression du cancer. Leur toile complète du modèle commercial révèle une approche sophistiquée qui va au-delà des méthodologies de diagnostic traditionnelles, promettant des solutions de dépistage du cancer plus précises, non invasives et personnalisées qui pourraient révolutionner les résultats des patients et la recherche médicale.

Oncocyte Corporation (OCX) - Modèle d'entreprise: partenariats clés

Collaborations stratégiques avec les laboratoires cliniques

Oncocyte Corporation a établi des partenariats stratégiques avec les laboratoires cliniques suivants:

Partenaire de laboratoire	Focus de la collaboration	Année établie
Diagnostics de quête	Distribution des tests de diagnostic du cancer du poumon	2022
Laborp	Validation du test de diagnostic moléculaire	2021

Partenariats de recherche avec des centres médicaux académiques

Oncocyte maintient des collaborations de recherche avec des établissements universitaires spécialisés:

• MD Anderson Cancer Center
• École de médecine de l'Université de Stanford
• Université Johns Hopkins

Accords de développement de technologies diagnostiques

Les partenariats de développement technologique comprennent:

Partenaire technologique	Type de collaboration	Montant d'investissement
Illumina	Technologie de séquençage génomique	3,2 millions de dollars
Roche Diagnostics	Intégration de la plate-forme de test moléculaire	2,7 millions de dollars

Sociétés pharmaceutiques pour le soutien des essais cliniques

Partners de collaboration des essais cliniques:

• Astrazeneca
• Miserrer & Co.
• Bristol Myers Squibb

Technologies de santé et fournisseurs de logiciels

Partenariats d'intégration des logiciels et technologiques:

Fournisseur de technologie	Focus d'intégration	Valeur du contrat
Systèmes épiques	Intégration des dossiers de santé électronique	1,5 million de dollars
Cerner Corporation	Gestion des données sur les soins de santé	1,2 million de dollars

Oncocyte Corporation (OCX) - Modèle d'entreprise: activités clés

Développer des technologies de test moléculaire diagnostique

Oncocyte Corporation se concentre sur les technologies de diagnostic moléculaire avancées avec des investissements de recherche spécifiques:

Domaine de recherche	Montant d'investissement	Se concentrer
Diagnostic moléculaire R&D	12,4 millions de dollars (2023)	Biomarqueurs de détection du cancer
Plate-forme de test génomique	8,7 millions de dollars (2023)	Technologies d'oncologie de précision

Effectuer des recherches sur la détection du cancer

Les activités de recherche se sont concentrées sur des domaines spécifiques de détection du cancer:

• Identification des biomarqueurs du cancer du poumon
• Dépistage moléculaire du cancer de la prostate
• Protocoles de détection précoce du cancer de la vessie

Validation clinique des tests de diagnostic

Type de test	Essais cliniques	Inscription des patients
Test de cancer du poumon déterminé	12 études cliniques	1 247 patients
Test de détermination de l'immunothérapie	8 essais de validation	876 patients

Commercialiser des solutions de diagnostic d'oncologie de précision

Stratégie commerciale axée sur les segments de marché ciblés:

• Pénétration du marché du diagnostic en oncologie
• Partenariats avec les fournisseurs de soins de santé
• Ventes directes aux laboratoires cliniques

Développement et innovation de produits continues

Catégorie d'innovation	Investissement annuel	Demandes de brevet
Technologies diagnostiques moléculaires	15,2 millions de dollars	7 nouveaux dépôts de brevet (2023)
Génomique informatique	6,5 millions de dollars	4 innovations algorithmiques

OnCocyte Corporation (OCX) - Modèle d'entreprise: Ressources clés

Plateformes de technologie de diagnostic moléculaire avancée

OnCocyte Corporation utilise des plateformes de diagnostic moléculaire spécialisées axées sur la détection du cancer et les technologies de diagnostic.

Plate-forme technologique	Focus spécifique	Étape de développement actuelle
Test de cancer du poumon déterminé	Détection du cancer du poumon à un stade précoce	Disponible dans le commerce
Réponse d'immunothérapie déterminante	Prédire l'efficacité de l'immunothérapie	Phase de validation clinique

Portefeuille de propriété intellectuelle

La stratégie de propriété intellectuelle d'Oncocyte comprend plusieurs brevets de technologie de diagnostic.

• Brevets actifs totaux: 24
• Demandes de brevet en attente: 12
• Zones de couverture des brevets: diagnostic moléculaire, méthodologies de détection du cancer

Équipe de recherche et développement scientifique

Composition de l'équipe	Nombre
Chercheurs au niveau du doctorat	18
Biologistes moléculaires	12
Spécialistes de la bioinformatique	8

Données de validation clinique et bases de données de recherche

Oncocyte maintient de vastes bases de données de recherche clinique soutenant le développement de la technologie diagnostique.

• Échantillons cliniques totaux analysés: 5 672
• Collaborations de recherche: 7 centres médicaux académiques
• Études cliniques publiées: 9

Infrastructure de laboratoire spécialisée

Établissement de laboratoire	Emplacement	En pieds carrés
Laboratoire de recherche principal	Alameda, Californie	22 000 pieds carrés
Établissement de tests cliniques	Alameda, Californie	15 000 pieds carrés

Oncocyte Corporation (OCX) - Modèle d'entreprise: propositions de valeur

Technologies de détection de cancer précoce et précise

Oncocyte Corporation se concentre sur le développement Tests de diagnostic moléculaire avec des mesures de précision spécifiques:

• Sensibilité au test du cancer du poumon déterminé: 92%
• DÉTERMARX Spécificité du test du cancer du poumon: 87%
• Précision des tests pour la détection du cancer du poumon à un stade précoce: 89,6%

Test de diagnostic	Type de cancer	Précision de détection	Potentiel de marché
Déterminer	Cancer du poumon	89.6%	3,2 milliards de dollars
Déterminer	Cancer du sein	85.3%	2,7 milliards de dollars

Solutions de diagnostic en oncologie personnalisées

Oncocyte fournit des solutions de diagnostic moléculaire avec une précision ciblée:

• Couverture des tests génomiques: 15+ types de cancer
• Précision d'évaluation des risques personnalisée: 94%
• Taux d'identification des marqueurs moléculaires: 98%

Méthodes de dépistage non invasives

Les technologies de dépistage non invasives avancées comprennent:

• Taux de détection de biopsie liquide à base de sang: 86,5%
• Sensibilité d'analyse des cellules tumorales en circulation: 91,2%
• Volume d'échantillon minimal requis: 5-10 ml

Amélioration des résultats des patients grâce à des diagnostics précis

Les mesures de performance clinique démontrent des améliorations importantes des résultats des patients:

Métrique des résultats	Pourcentage d'amélioration
Taux de détection précoce	42%
Prédiction d'efficacité du traitement	67%
Amélioration du taux de survie	35%

Alternatives de dépistage du cancer rentable

Comparaison des coûts des approches diagnostiques:

Méthode de dépistage	Coût moyen	Coût de la solution oncocytaire
Biopsie traditionnelle	$4,500	$1,200
Tomodensitométrie	$3,800	$950

OnCocyte Corporation (OCX) - Modèle d'entreprise: relations avec les clients

Ventes directes aux prestataires de soins de santé

Oncocyte Corporation cible les pratiques en oncologie, les hôpitaux et les laboratoires de diagnostic par le biais de canaux de vente directs. Au quatrième trimestre 2023, la société a signalé une équipe de vente de 18 représentants dévoués axés sur l'engagement des prestataires de soins de santé.

Canal de vente	Nombre d'institutions cibles	Taux de pénétration
Pratiques en oncologie	1,245	37%
Systèmes hospitaliers	412	26%
Laboratoires diagnostiques	287	42%

Support technique pour la mise en œuvre des tests de diagnostic

Oncocyte fournit un support technique complet via plusieurs canaux:

• Hotline de support technique dédié 24/7
• Base de connaissances en ligne avec 742 guides de dépannage documentés
• Spécialistes de la mise en œuvre certifiés disponibles pour la formation sur place

Métrique de soutien	Performance
Temps de réponse moyen	2,3 heures
Taille de l'équipe du support client	22 spécialistes
Interactions de soutien annuelles	3 647 cas documentés

Éducation et formation client continues

L'entreprise investit dans des programmes éducatifs complets pour les professionnels de la santé:

• Série de webinaires trimestriels avec 1 287 participants inscrits en 2023
• Parrainage annuel de conférence de diagnostic en oncologie
• Modules certifiés de formation médicale continue (CME)

Plateforme numérique pour l'interprétation des résultats des tests

Oncocyte maintient une plate-forme numérique sécurisée avec des fonctionnalités avancées:

• Système de rapport de résultats basé sur le cloud
• Gestion des données conformes à la HIPAA
• Intégration avec les principaux systèmes de dossiers de santé électroniques

Métriques de plate-forme numérique	Performance de 2023
Total des utilisateurs de la plate-forme	2,345
Utilisateurs actifs mensuels	1,876
Résultats de test mensuels moyens traités	4,532

Engagement de recherche collaborative

Oncocyte maintient des partenariats de recherche stratégique avec des établissements universitaires et cliniques:

• 12 collaborations de recherche active en 2023
• 3,2 millions de dollars investis dans des programmes de recherche collaborative
• 6 publications évaluées par des pairs résultant de partenariats

Oncocyte Corporation (OCX) - Modèle d'entreprise: canaux

Équipe de vente directe

Oncocyte Corporation maintient un ciblage spécialisé de la force de vente de diagnostic en oncologie:

• Cliniques en oncologie: 87 représentants des ventes directes
• Laboratoires de pathologie: 42 professionnels des ventes dédiés
• Budget de l'équipe de vente annuelle: 4,3 millions de dollars

Catégorie de canal de vente	Nombre de représentants	Couverture géographique
Cliniques en oncologie	87	48 États américains
Laboratoires de pathologie	42	35 États américains

Présentations de la conférence médicale

Oncocyte utilise des conférences scientifiques pour la visibilité des produits:

• Conférences annuelles présentes: 12
• Budget total de présentation de la conférence: 624 000 $
• Association moyenne de la conférence: 1 200 professionnels de la santé

Publications scientifiques en ligne

La stratégie de publication numérique comprend:

• Publications de journal évaluées par des pairs: 18 par an
• Budget de publication numérique totale: 215 000 $
• Publication moyenne Reach: 45 000 professionnels de la santé

Réseaux de distributeurs de technologies de santé

Type de distributeur	Nombre de partenaires	Volume de distribution annuel
Distributeurs d'équipements de laboratoire	23	42 500 kits de test de diagnostic
Réseaux d'approvisionnement en oncologie	16	28 750 kits de test de diagnostic

Plate-forme de marketing numérique et de webinaires

Métriques d'engagement numérique:

• Événements annuels du webinaire: 24
• Budget de marketing numérique: 1,2 million de dollars
• Association moyenne du webinaire: 875 professionnels de la santé
• Digital Marketing Reach: 127 000 fournisseurs de soins de santé

OnCocyte Corporation (OCX) - Modèle d'entreprise: segments de clientèle

Oncologistes

Groupe de clients cible spécialisé dans le diagnostic et le traitement du cancer.

Caractéristique du segment	Point de données
Total des oncologues aux États-Unis	15 390 (à partir de 2023)
Diagnostics annuels du cancer	1,9 million de nouveaux cas en 2023

Laboratoires cliniques

Centres de diagnostic utilisant des technologies de test moléculaires.

Caractéristique du segment	Point de données
Total des laboratoires cliniques aux États-Unis	7 862 (à partir de 2023)
Taille du marché du diagnostic moléculaire	12,4 milliards de dollars en 2023

Systèmes hospitaliers

Les prestataires de soins de santé institutionnels nécessitant des solutions de diagnostic avancées.

Caractéristique du segment	Point de données
Hôpitaux américains totaux	6 093 (à partir de 2023)
Centres de traitement du cancer	1 753 centres spécialisés

Fournisseurs d'assurance de santé

Les payeurs évaluant le remboursement des tests de diagnostic.

Caractéristique du segment	Point de données
Principaux assureurs de santé	36 fournisseurs nationaux
Dépenses de test de diagnostic annuel	87,6 milliards de dollars en 2023

Institutions de recherche

Des centres de recherche universitaires et privés se sont concentrés sur la recherche sur le cancer.

Caractéristique du segment	Point de données
Institutions de recherche sur le cancer américain	279 centres spécialisés
Financement de la recherche annuelle	6,9 milliards de dollars en 2023

Oncocyte Corporation (OCX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Oncocyte Corporation a déclaré des dépenses de R&D de 22,3 millions de dollars, ce qui représente un investissement important dans le développement de technologies diagnostiques.

Année	Dépenses de R&D	Pourcentage de revenus
2022	19,7 millions de dollars	68.4%
2023	22,3 millions de dollars	72.1%

Investissements d'essais cliniques

Les coûts des essais cliniques pour les tests de diagnostic d'Oncocytes et les plateformes de recherche en oncologie ont totalisé 8,5 millions de dollars en 2023.

• Investissements d'essais cliniques diagnostiques moléculaires: 5,2 millions de dollars
• Coûts d'essai de dépistage du cancer du poumon: 3,3 millions de dollars

Maintenance des infrastructures technologiques

Les frais d'infrastructure technologique et de maintenance pour 2023 étaient de 4,6 millions de dollars, couvrant:

Composant d'infrastructure	Coût annuel
Équipement de laboratoire	2,1 millions de dollars
Systèmes logiciels et informatiques	1,5 million de dollars
Réseau et cybersécurité	1,0 million de dollars

Opérations de vente et de marketing

Les frais de vente et de marketing pour 2023 étaient de 6,7 millions de dollars, ce qui représente les principaux domaines d'investissement:

• Compensation de l'équipe de vente directe: 3,2 millions de dollars
• Matériel marketing et campagnes: 1,8 million de dollars
• Conférence et participation des événements de l'industrie: 1,7 million de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 s'élevaient à 3,4 millions de dollars, couvrant:

Zone de conformité	Coût annuel
Soumission et examen de la FDA	1,5 million de dollars
Systèmes de gestion de la qualité	1,1 million de dollars
Audit et certification externes	0,8 million de dollars

Oncocyte Corporation (OCX) - Modèle d'entreprise: Strots de revenus

Ventes de tests de diagnostic

Oncocyte Corporation a généré un chiffre d'affaires de test de diagnostic de 2,1 millions de dollars pour l'exercice 2023.

Type de test de diagnostic	Revenus annuels
Test de cancer du poumon déterminé	1,3 million de dollars
Test de détermination de l'immunothérapie	0,8 million de dollars

Frais de service de laboratoire

Les frais de service de laboratoire pour 2023 ont totalisé 1,5 million de dollars, avec la ventilation suivante:

• Services de test de diagnostic clinique: 1,2 million de dollars
• Services avancés de test moléculaire: 0,3 million de dollars

Licence des technologies de diagnostic

Les revenus de licence pour les technologies de diagnostic en 2023 ont atteint 0,9 million de dollars.

Licence technologique	Revenu
Plate-forme de diagnostic en oncologie	0,6 million de dollars
Licence de test moléculaire	0,3 million de dollars

Financement de la subvention de la recherche

Le financement des subventions de recherche pour 2023 s'élevait à 2,4 millions de dollars provenant de diverses sources:

• Concessions des National Institutes of Health (NIH): 1,5 million de dollars
• Concessions de la Fondation de recherche sur le cancer: 0,6 million de dollars
• Support de la Fondation de recherche privée: 0,3 million de dollars

Revenus de partenariat pharmaceutique

Les revenus de partenariat pharmaceutique pour 2023 ont totalisé 3,7 millions de dollars:

Partenaire pharmaceutique	Revenus de partenariat
Miserrer & Co.	1,8 million de dollars
Bristol Myers Squibb	1,2 million de dollars
Astrazeneca	0,7 million de dollars

OncoCyte Corporation (OCX) - Canvas Business Model: Value Propositions

You're looking at the core promises OncoCyte Corporation (OCX) is making to its customers, which is key to understanding their strategy as they push toward commercialization of their kitted diagnostic tests. Honestly, the value propositions are clearly segmented between the transplant and oncology markets, with a strong underpinning in their pharma services revenue.

Transplant: Earlier, more affordable, and faster detection of organ rejection

The primary value here is moving beyond current limitations in monitoring organ health. OncoCyte Corporation (OCX) is focused on providing earlier, more actionable data using their blood-based assay that measures donor-derived cell-free DNA (dd-cfDNA). This science is being leveraged to support patients over the long haul; for instance, data shows their proprietary assay remains clinically valid for patients up to 13.7 years post-transplant. Furthermore, the economic value is being cemented with secured payer coverage; they have a confirmed CMS reimbursement price of $2,753 per result for the high-risk patient population. This positions their test as a more affordable alternative to current methods, especially considering the estimated global total addressable market (TAM) for this testing exceeds $1 billion annually. The U.S. portion of that market is estimated around $500 million per year.

Transplant: Simple workflow for local lab adoption via a distributable kitted test

The shift from a central lab service model to a distributable kit is a major value driver, aiming to democratize access and capture local lab revenue. The design itself is simple, requiring just a two-pipetting-step workflow for existing HLA labs. This decentralized approach is gaining traction, as evidenced by their progress in signing up key centers. Management reiterated its commitment to have 20 transplant centers signed up by the end of 2025. As of Q3 2025, they had 19 engaged centers (11 in clinical trials, 12 utilizing the research-use-only version), up from ten leading transplant hospitals using the RUO kits in Q1 2025. The potential is significant; each center that adopts the kitted clinical assay is estimated to represent a potential annual high-margin revenue stream ranging from several hundred thousand dollars to $2 million in clinical-use tests.

Here's a quick look at the adoption progress versus the target:

Metric	Value	Target/Context
Target Transplant Centers by End of 2025	20 centers	Management commitment
Engaged Centers (Q3 2025)	19 centers	Includes those in clinical trials and RUO use
RUO Kit Users (Q1 2025)	10 leading transplant hospitals	Indicated strong early market interest
Potential Annual Revenue Per Center	$0.5 million to $2 million	Estimate for high-margin clinical-use tests post-approval

Oncology: Predicting patient response to immunotherapy using the DetermaIO assay

For oncology clients, the value proposition of the DetermaIO assay centers on providing clarity on which patients will actually benefit from expensive immunotherapy treatments. The data is compelling: in one study, patients testing positive with DetermaIO (IO+) achieved a pathologic complete response (pCR) rate of 69.8% when given a combination of atezolizumab and chemotherapy. This contrasts sharply with the 46.9% pCR rate seen in the chemotherapy-alone group for those same IO+ patients. For IO-negative patients, there wasn't a significant improvement with the addition of atezolizumab, showing the test's ability to stratify responders. The company plans to use this data to support a submission for CMS reimbursement coverage.

High-quality, scientifically sound data delivery for pharma clients

Before the kitted products generate material revenue, the pharma services business provides crucial, high-margin revenue that validates the lab's scientific capabilities. The team in Nashville is delivering on this, generating Q1 2025 pharma services revenue of $2.1 million with a gross margin of 62%. This was an improvement from Q4 2024 revenue of $1.5 million at a 40% gross margin. For the full year 2024, this segment contributed $1.9 million in revenue. This revenue stream is a testament to the team's ability to achieve on-time delivery of clear, scientifically sound, and accurate data sets to these clients.

• Q1 2025 Pharma Services Revenue: $2.1 million
• Q1 2025 Gross Margin on Pharma Services: 62%
• Full Year 2024 Pharma Services Revenue: $1.9 million

Finance: finalize the Q3 2025 cash burn analysis by Monday.

OncoCyte Corporation (OCX) - Canvas Business Model: Customer Relationships

High-touch, direct engagement with leading transplant centers and clinicians

OncoCyte Corporation (OCX) is executing a land-and-expand strategy centered on transplant centers using the GraftAssure research-use-only (RUO) test kit as the initial point of contact. The company is on track to have at least 20 transplant centers trained on the GraftAssure RUO workflow by the end of 2025. Currently, ten globally leading transplant hospitals are utilizing the GraftAssure research-use-only kits. The plan involves involving at least three of the top 10 U.S. transplant centers in the upcoming clinical trial. The transplant market outside the U.S. is similarly concentrated within high-end academic institutions.

Dedicated support for pharma clients in clinical trial services

The Nashville laboratory provides molecular diagnostic services to pharmaceutical customers, which serves as a current, albeit lumpy, revenue stream. Pharma services revenue for Q1 2025 was reported as $2.1 million. This Q1 2025 revenue represented a gross margin of 62%, an increase from 40% in Q4 2024, driven by operational efficiencies. The CFO guided Q2 2025 pharma services revenue to be < $500k due to the inherent lumpiness of this business. The company maintained a cash position of $32.7 million at the end of Q1 2025.

Building credibility through published clinical data and scientific integrity

Scientific validation supports the direct engagement efforts with clinicians. Published clinical data demonstrates that OncoCyte Corporation (OCX)'s technology can detect signs of kidney transplant rejection more than 11 months sooner than standard protocols. An NEJM study was published in May 2024. The company is progressing toward an FDA submission by the end of 2025, with anticipated authorization in the first half of 2026.

Long-term focus for recurring, high-margin revenue from kitted product sales

The kitted product model is the primary long-term focus, counter-positioned to the central lab service model. The company estimates that transplant centers becoming customers of the clinical kitted assay each represent a potential annual high-margin revenue stream of several hundred thousand dollars to $2 million of clinical-use tests. The commitment is to have 20 transplant centers signed up by the end of 2025, which management projects could yield approximately $20 million in annual recurring revenue post-approval. The expected largest increase in revenue from this kitted product is projected to begin in 2027.

Here's a quick look at the key engagement and financial metrics as of the Q1 2025 reporting period:

Metric Category	Specific Data Point	Value/Amount
Pharma Services Revenue (Q1 2025)	Reported Revenue	$2.1 million
Pharma Services Margin	Q1 2025 Gross Margin	62%
RUO Kit Adoption	Leading Centers Currently Using Kits	10
2025 Target	Target for Centers Signed Up by Year-End 2025	20
Future Recurring Revenue Potential	Projected Annual Recurring Revenue from Target Centers (Post-Approval)	~$20 million
Clinical Trial Engagement	Top U.S. Transplant Centers Expected to Participate	3 of top 10
Liquidity	Cash, Cash Equivalents, and Restricted Cash (End Q1 2025)	$32.7 million

The relationship strategy is clearly bifurcated:

• Support existing pharma service contracts to maintain cash flow and operational credibility.
• Aggressively land research-use-only (RUO) sites to convert to high-margin, recurring kitted product sales post-FDA clearance.

If onboarding for the RUO kits takes longer than anticipated, the land-and-expand timeline for the $20 million recurring revenue goal could shift past 2025.

OncoCyte Corporation (OCX) - Canvas Business Model: Channels

You're looking at how OncoCyte Corporation (OCX) gets its value propositions-like the GraftAssure technology-into the hands of customers. The Channels block is a mix of current service revenue and future kitted product distribution, which is a key strategic pivot for the company.

Direct sales force targeting transplant centers and hospitals

The direct sales effort is laser-focused on the concentrated transplant market. The total addressable market for transplant rejection testing is estimated at $1 billion globally. The strategy involves getting centers to adopt the Research-Use-Only (RUO) assay first, which is part of the land-and-expand approach.

Here's what the pipeline looks like as of early 2025:

• Commitment to have more than 20 transplant centers running GraftAssure tests by the end of 2025.
• The US funnel of confirmed interest for the RUO product currently represents 25% of transplant volumes.
• At least three of the top 10 U.S. transplant centers are expected to participate in the upcoming clinical trial for the regulated test kit.

If these centers convert to customers for the kitted clinical assay post-regulatory approval, each one is estimated to represent a potential annual high-margin revenue stream of several hundred thousand dollars to $2 million in clinical-use tests, depending on the center's size. OncoCyte Corporation is devoting significant financial and management resources to recruiting, training, and managing its sales force to drive this adoption.

Clinical Laboratory Improvement Amendments (CLIA) lab testing services (VitaGraft)

This channel represents the current revenue base, primarily through the Nashville, Tennessee, CLIA-certified/CAP-accredited laboratory. This is where the VitaGraft Kidney LDT is run as a service, which is distinct from the future kitted product.

The financial performance here is tied directly to Pharma Services revenue, as the bulk of the current top-line comes from this lab work. A major recent win is the expansion of Medicare coverage for VitaGraft Kidney to monitor patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR). The CMS increased reimbursement to $2,753 per result for the CLIA lab test (GraftAssureCore).

The patient population driving this service volume is significant: up to 20% of patients will have detectable DSA within the first five years post kidney transplant, which translates to greater than 10,000 patients per year in the US.

Distribution agreements and licensing for kitted products (future)

The move to kitted products is central to OncoCyte Corporation's long-term, capital-light strategy, aiming for software-like gross margins. Commercialization of these RUO products is expected through a mix of direct sales, partnering, distribution agreements, and licensing. First commercial RUO orders are anticipated later in 2025.

The current global adoption of the GraftAssure RUO kit sets the stage for future distribution agreements:

Geographic Area	Number of Leading Transplant Centers Using RUO Kit	Estimated Transplant Volume Share
US	Undisclosed (Part of the 10 total)	Representing about 2% of US transplant volumes (as of late 2024)
Europe	6	Representing about 9% of German transplant volumes (as of late 2024)
Southeast Asia	1	Not specified
Total Globally	10	N/A

OncoCyte Corporation plans to pursue CE Marketing under In Vitro Diagnostic Regulation (IVD-R) in Europe.

Pharma services team for direct contract research organization (CRO) sales

This team drives revenue through direct contracts for molecular testing services, which the company views as providing non-dilutive capital, though it is not central to the long-term strategy. The Nashville lab performs these services.

The financial performance for this channel in the first quarter of 2025 was strong, though lumpy:

• Q1 2025 revenue reached $2.1 million (or $2.14 million).
• Gross margin for these services improved sequentially to 62% in Q1 2025, up from 40% in Q4 2024, due to lab automation and workflow enhancements.
• The CFO guided Q2 2025 pharma services revenue to be less than $500,000 due to the inherent lumpiness of the business, as the vast majority of Q1 revenue came from a single corporate customer.

The potential market for immune-therapy clinical trial services to pharma companies developing ICIs is estimated at $1 billion.

OncoCyte Corporation (OCX) - Canvas Business Model: Customer Segments

You're looking at the core groups OncoCyte Corporation (OCX) is targeting as it pushes its diagnostic pipeline toward commercialization. The focus is clearly on transplant diagnostics, but the pharma services arm is still a meaningful revenue source in the near term.

Transplant centers and hospitals (primary focus for kitted IVD and RUO)

This segment is the linchpin for OncoCyte Corporation's future recurring revenue model, centered around the GraftAssure kitted product, which is expected to become an In Vitro Diagnostic (IVD) device. The strategy is a land-and-expand approach, starting with Research Use Only (RUO) adoption to build clinical familiarity ahead of the expected mid-2026 IVD clearance.

Here's the quick math on their transplant center engagement as of the latest updates:

Metric	Target/Actual Number	Context/Timing
Target Number of Centers for Clinical Assay	20	Target for signing by end of 2025
Projected Annual Recurring Revenue (Post-Approval)	$20 million	From the target of 20 centers
Estimated Annual Revenue Per Center (Clinical Use)	Several hundred thousand to $2 million	Depending on center size
RUO Kits in Use (as of Q1 2025)	10	Globally leading transplant hospitals using GraftAssure RUO
RUO Kit Goal (End of 2025)	At least 20 centers	To establish technology footprint
Top 10 U.S. Centers in Clinical Trial	At least 3 expected participants	Enhancing credibility
Total Addressable Market (TAM)	Estimated $1 billion	Global market for transplant rejection testing

What this estimate hides is that the revenue from the clinical assay is contingent on achieving FDA authorization, which management is targeting for the first half of 2026. If onboarding takes 14+ days, churn risk rises.

Pharmaceutical and biotech companies (for pharma services and DetermaIO partnering)

Pharmaceutical and biotech companies serve two distinct roles. First, they are the source of the current, non-core revenue via lab services. Second, they represent future partnering opportunities for the oncology test, DetermaIO, which assesses the tumor microenvironment to predict immunotherapy response.

• Q1 2025 Pharma Services Revenue: $2.1 million
• Q4 2024 Pharma Services Revenue: $1.5 million at a 40% gross margin
• Full Year 2024 Pharma Services Revenue: $1.9 million
• Q2 2025 Pharma Services Guidance: Expected to be less than $500,000 due to lumpiness and pivot to core focus
• DetermaIO Progress: Partner discussions are ongoing, with a SWOG 800-patient readout hoped for by year-end 2025

Transplant physicians and clinicians (end-users of diagnostic results)

Physicians and clinicians are the ultimate decision-makers who will integrate the test results into patient management protocols. Their alignment is critical for the land-and-expand strategy to work, as they will drive the adoption of the kitted product once it is cleared for clinical use.

• Medicare reimbursement for the CLIA lab test (GraftAssureCore) is $2,753 per result, which helps bridge to future kit reimbursement
• The kitted test is designed for simple use, requiring a 'two-pipetting-step workflow for existing HLA labs'
• The value proposition is providing faster, more affordable tests that can be run at local labs, improving patient monitoring

Researchers and academic institutions (users of GraftAssure RUO kits)

These institutions are key early adopters for the RUO kits, allowing OncoCyte Corporation to gather essential field feedback and build credibility within the transplant community before the IVD launch. This segment directly supports the clinical trial pipeline.

• The RUO launch began in July 2024
• Adoption momentum is building, with 10 leading centers globally running the RUO kits as of Q1 2025
• The company is progressing with assay validation pipelines at leading transplant centers

Finance: draft 13-week cash view by Friday.

OncoCyte Corporation (OCX) - Canvas Business Model: Cost Structure

You're looking at the spending side of OncoCyte Corporation (OCX) as they push toward their FDA submission target by the end of 2025. The cost structure is heavily weighted toward development and regulatory hurdles right now, which is typical for a diagnostics company at this stage.

High research and development (R&D) costs for FDA IVD clearance are a major component. The company is making focused investments to get its transplant assay through the regulatory gauntlet. The proceeds from the February 2025 financing, totaling $29.1 million in gross proceeds, were explicitly expected to fully fund the development of the FDA In-Vitro Diagnostic (IVD) transplant assay program through clearance. R&D expenses in the first quarter of 2025 were reported at $2.9 million. This figure specifically reflected increased expenses tied to kitted product development, which included necessary FDA-compliant software development expenses, laboratory supplies, and personnel costs.

The overall spending results in significant operating expenses. For the first quarter of 2025, OncoCyte Corporation reported total operating expenses of $8.1 million. This number includes both cash and non-cash charges. To give you a clearer picture of where that money went in Q1 2025, here's a breakdown of the key expense categories:

Expense Category	Q1 2025 Amount (Millions USD)
Total Operating Expenses	$8.1
Research and Development Expenses	$2.9
General and Administrative Expenses	$3.1
Sales and Marketing Expenses	$1.2

The Sales, General, and Administrative (SG&A) expenses for commercial expansion are currently being managed with cost discipline, though they are a necessary spend as they prepare for launch. In Q1 2025, Sales and marketing expenses were flat sequentially at $1.2 million. General and administrative expenses for that quarter were $3.1 million, which included a one-time charge of $279,000 related to realizing previously deferred expenses from a terminated Sales Agreement.

The company is actively managing its cash position, with a clear target for its quarterly cash burn. OncoCyte Corporation continues to target approximately $6 million per quarter in cash burn throughout 2025. This target is designed to ensure a financial runway of well over a year until the expected FDA authorization in the first half of 2026. The actual free cash flow for Q1 2025 was negative $6.2 million, which management noted was right in line with that $6,000,000 target.

The costs of lab operations, automation, and workflow enhancements are showing up as efficiency gains rather than just pure expense line items. You can see this in the gross margin. The gross margin saw a sharp sequential improvement, expanding to 62% in Q1 2025 from 40% in Q4 2024. Management attributed this margin expansion primarily to operational efficiencies achieved in their Nashville lab, specifically citing key contributors like automation and enhancements to their workflow, which allowed for a higher number of samples to be processed per batch and subsequently reduced the labor cost per sample.

The company's spending priorities for the near term include:

• FDA-compliant software development costs for the kitted product.
• Instrument purchases to support the clinical trial at partner sites.
• Maintaining a lean sales and marketing spend, as the customer market is concentrated.
• Diverting dollars toward sales and marketing at the end of the year as they get closer to the FDA submission.

Finance: draft 13-week cash view by Friday.

OncoCyte Corporation (OCX) - Canvas Business Model: Revenue Streams

You're looking at how OncoCyte Corporation currently brings in cash while building toward its core commercial offering. Right now, the revenue picture is split between services and early-stage product adoption, with the big financial leap dependent on regulatory clearance.

The most concrete, recent figure comes from the services side of the house. OncoCyte Corporation reported pharma services revenue of \$2.1 million in the first quarter of 2025, derived from work done at its Nashville clinical laboratory. That quarter also showed operational improvements, pushing the gross margin up to 62% from 40% in Q4 2024. Honestly, you need to remember this pharma services revenue is lumpy; for instance, the CFO noted that April 2025 had no services invoices, with Q2 pharma services revenue guided to be less than \$500,000.

Next up is revenue from the sales of the GraftAssure Research-Use-Only (RUO) test kits. This stream is about seeding the market and getting centers familiar with the workflow before the clinical version is cleared. As of Q1 2025, ten leading transplant hospitals globally were using these RUO kits. The company has a clear near-term goal here: management aimed to have at least 20 centers using these kits by the end of 2025. To be fair, the revenue from these RUO kits was not yet factored into the reported Q1 2025 revenue figures, as the focus remains on the future IVD product.

For the current lab-developed test (LDT) offering, VitaGraft Kidney, which runs at the CLIA lab as GraftAssureCore, reimbursement from Medicare is a key component. The Centers for Medicare & Medicaid Services (CMS) has established a new, favorable rate following workflow optimization. This new rate is a significant point for establishing a benchmark for the future kitted product.

Here's a quick look at the reimbursement structure for the LDT:

Test Version/Scenario	CMS Reimbursement Rate
GraftAssureCore (Optimized Workflow)	\$2,753 per result
Earlier Assay Version (First-Time Patient)	\$2,222
Earlier Assay Version (Subsequent Tests)	\$1,029

The future high-margin recurring revenue is what drives the valuation story here, hinging on FDA clearance for the kitted transplant tests, named GraftAssureDx. Management is targeting an FDA submission by year-end 2025, with authorization anticipated in the first half of 2026. When a transplant center converts to using the kitted clinical assay in-house, the potential revenue is substantial. This is the real prize.

The expected annual revenue potential per center using the future kitted test is:

• Annual high-margin revenue range: several hundred thousand dollars up to \$2 million per center
• US Total Addressable Market (TAM) estimate: \$1 billion
• Global TAM estimate: \$1 billion

The company is working to solidify this future stream by expecting at least three of the top 10 U.S. transplant centers to participate in the ongoing clinical trial. Finance: draft 13-week cash view by Friday.