OncoCyte Corporation (OCX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama en rápida evolución de la oncología de precisión, Oncocyte Corporation (OCX) emerge como una fuerza pionera, transformando el diagnóstico de cáncer a través de tecnologías innovadoras de pruebas moleculares. Al unir estratégicamente la investigación de vanguardia, las plataformas de diagnóstico avanzadas y las asociaciones colaborativas, OCX está redefiniendo cómo los proveedores de atención médica detectan, comprenden e intervienen potencialmente en la progresión del cáncer. Su lienzo de modelo de negocio integral revela un enfoque sofisticado que va más allá de las metodologías de diagnóstico tradicionales, prometiendo soluciones de detección de cáncer más precisas, no invasivas y personalizadas que podrían revolucionar los resultados de los pacientes y la investigación médica.

Oncocyte Corporation (OCX) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con laboratorios clínicos

Oncocyte Corporation ha establecido asociaciones estratégicas con los siguientes laboratorios clínicos:

Socio de laboratorio	Enfoque de colaboración	Año establecido
Diagnóstico de misiones	Distribución de la prueba de diagnóstico de cáncer de pulmón	2022
Labcorp	Validación de la prueba de diagnóstico molecular	2021

Asociaciones de investigación con centros médicos académicos

Oncocyte mantiene colaboraciones de investigación con instituciones académicas especializadas:

• Centro de cáncer de MD Anderson
• Facultad de Medicina de la Universidad de Stanford
• Universidad de Johns Hopkins

Acuerdos de desarrollo de tecnología de diagnóstico

Las asociaciones de desarrollo de tecnología incluyen:

Socio tecnológico	Tipo de colaboración	Monto de la inversión
Ilumina	Tecnología de secuenciación genómica	$ 3.2 millones
Roche Diagnostics	Integración de la plataforma de prueba molecular	$ 2.7 millones

Empresas farmacéuticas para el apoyo de ensayos clínicos

Partidos de colaboración de ensayos clínicos:

• Astrazeneca
• Merck & Co.
• Bristol Myers Squibb

Proveedores de tecnología de salud y software

Asociaciones de integración de software y tecnología:

Proveedor de tecnología	Enfoque de integración	Valor de contrato
Sistemas épicos	Integración de registros de salud electrónicos	$ 1.5 millones
Corporación Cerner	Gestión de datos de atención médica	$ 1.2 millones

Oncocyte Corporation (OCX) - Modelo de negocio: actividades clave

Desarrollo de tecnologías de prueba molecular de diagnóstico

Oncocyte Corporation se centra en tecnologías de diagnóstico molecular avanzadas con inversiones de investigación específicas:

Área de investigación	Monto de la inversión	Enfocar
I + D de diagnóstico molecular	$ 12.4 millones (2023)	Biomarcadores de detección del cáncer
Plataforma de prueba genómica	$ 8.7 millones (2023)	Tecnologías de oncología de precisión

Realización de investigaciones de detección del cáncer

Actividades de investigación concentradas en dominios específicos de detección del cáncer:

• Identificación del biomarcador de cáncer de pulmón
• Detección molecular del cáncer de próstata
• Protocolos de detección temprana del cáncer de vejiga

Validación clínica de pruebas de diagnóstico

Tipo de prueba	Ensayos clínicos	Inscripción del paciente
Prueba de cáncer de pulmón de Detetarx	12 estudios clínicos	1.247 pacientes
Prueba de inmunoterapia de determinación	8 pruebas de validación	876 pacientes

Comercializando soluciones de diagnóstico de oncología de precisión

Estrategia comercial centrándose en segmentos de mercado específicos:

• Penetración del mercado de diagnóstico de oncología
• Asociaciones con proveedores de atención médica
• Ventas directas a laboratorios clínicos

Desarrollo e innovación de productos continuos

Categoría de innovación	Inversión anual	Solicitudes de patentes
Tecnologías de diagnóstico molecular	$ 15.2 millones	7 Nuevas presentaciones de patentes (2023)
Genómica computacional	$ 6.5 millones	4 innovaciones algorítmicas

Oncocyte Corporation (OCX) - Modelo de negocio: recursos clave

Plataformas de tecnología de diagnóstico molecular avanzado

Oncocyte Corporation utiliza plataformas de diagnóstico molecular especializadas que se centran en la detección del cáncer y las tecnologías de diagnóstico.

Plataforma tecnológica	Enfoque específico	Etapa de desarrollo actual
Prueba de cáncer de pulmón de Detetarx	Detección de cáncer de pulmón en etapa temprana	Disponible comercialmente
Respuesta a la inmunoterapia de determinación	Predecir la efectividad de la inmunoterapia	Fase de validación clínica

Cartera de propiedades intelectuales

La estrategia de propiedad intelectual de Oncocyte abarca múltiples patentes de tecnología de diagnóstico.

• Patentes activas totales: 24
• Solicitudes de patentes pendientes: 12
• Áreas de cobertura de patentes: diagnóstico molecular, metodologías de detección del cáncer

Equipo de Investigación y Desarrollo Científico

Composición del equipo	Número
Investigadores a nivel de doctorado	18
Biólogos moleculares	12
Especialistas en bioinformática	8

Datos de validación clínica y bases de datos de investigación

Oncocyte mantiene extensas bases de datos de investigación clínica que respaldan el desarrollo de tecnología de diagnóstico.

• Total de muestras clínicas analizadas: 5.672
• Colaboraciones de investigación: 7 centros médicos académicos
• Estudios clínicos publicados: 9

Infraestructura de laboratorio especializada

Instalación de laboratorio	Ubicación	Pies cuadrados
Laboratorio de investigación principal	Alameda, California	22,000 pies cuadrados
Instalación de pruebas clínicas	Alameda, California	15,000 pies cuadrados

Oncocyte Corporation (OCX) - Modelo de negocio: propuestas de valor

Tecnologías de detección de cáncer tempranas y precisas

Oncocyte Corporation se centra en el desarrollo Pruebas de diagnóstico molecular con métricas de precisión específicas:

• Sensibilidad de la prueba de cáncer de pulmón de Detetarx: 92%
• Detdarx Pulgue Cancer Eppecificidad: 87%
• Precisión de la prueba para la detección de cáncer de pulmón en etapa temprana: 89.6%

Prueba de diagnóstico	Tipo de cáncer	Precisión de detección	Potencial de mercado
Determinante	Cáncer de pulmón	89.6%	$ 3.2 mil millones
Determinante	Cáncer de mama	85.3%	$ 2.7 mil millones

Soluciones de diagnóstico de oncología personalizada

Oncocyte proporciona soluciones de diagnóstico molecular con precisión dirigida:

• Cobertura de prueba genómica: más de 15 tipos de cáncer
• Precisión de evaluación de riesgos personalizada: 94%
• Tasa de identificación del marcador molecular: 98%

Métodos de detección no invasivos

Las tecnologías avanzadas de detección no invasivas incluyen:

• Tasa de detección de biopsia líquida a base de sangre: 86.5%
• Sensibilidad de análisis de células tumorales circulantes: 91.2%
• Se requiere un volumen de muestra mínimo: 5-10 ml

Mejores resultados del paciente a través de diagnósticos precisos

Las métricas de rendimiento clínico demuestran mejoras significativas de resultados del paciente:

Métrico de resultado	Porcentaje de mejora
Tasa de detección temprana	42%
Predicción de eficacia del tratamiento	67%
Mejora de la tasa de supervivencia	35%

Alternativas de detección de cáncer rentables

Comparación de costos de enfoques de diagnóstico:

Método de detección	Costo promedio	Costo de solución de oncocitos
Biopsia tradicional	$4,500	$1,200
Escaneo	$3,800	$950

Oncocyte Corporation (OCX) - Modelo de negocios: relaciones con los clientes

Ventas directas a proveedores de atención médica

Oncocyte Corporation se dirige a prácticas de oncología, hospitales y laboratorios de diagnóstico a través de canales de venta directos. A partir del cuarto trimestre de 2023, la compañía reportó un equipo de ventas de 18 representantes dedicados centrados en la participación del proveedor de atención médica.

Canal de ventas	Número de instituciones objetivo	Tasa de penetración
Prácticas oncológicas	1,245	37%
Sistemas hospitalarios	412	26%
Laboratorios de diagnóstico	287	42%

Soporte técnico para la implementación de pruebas de diagnóstico

Oncocyte proporciona soporte técnico integral a través de múltiples canales:

• Línea directa de soporte técnico dedicado 24/7
• Base de conocimiento en línea con 742 guías de solución de problemas documentadas
• Especialistas de implementación certificados disponibles para capacitación en el sitio

Métrico de soporte	Actuación
Tiempo de respuesta promedio	2.3 horas
Tamaño del equipo de atención al cliente	22 especialistas
Interacciones de soporte anual	3.647 casos documentados

Educación y capacitación continuas del cliente

La compañía invierte en programas educativos integrales para profesionales de la salud:

• Serie de seminarios web trimestrales con 1.287 participantes registrados en 2023
• Patrocinio anual de la conferencia de diagnóstico de oncología
• Módulos certificados de educación médica continua (CME)

Plataforma digital para la interpretación de resultados de prueba

Oncocyte mantiene una plataforma digital segura con características avanzadas:

• Sistema de informes de resultados basado en la nube
• Gestión de datos compatible con HIPAA
• Integración con los principales sistemas de registros de salud electrónicos

Métricas de plataforma digital	2023 rendimiento
Usuarios totales de la plataforma	2,345
Usuarios activos mensuales	1,876
Resultados promedio de las pruebas mensuales procesados	4,532

Compromiso de investigación colaborativa

Oncocyte mantiene asociaciones de investigación estratégica con instituciones académicas y clínicas:

• 12 colaboraciones de investigación activa en 2023
• $ 3.2 millones invertidos en programas de investigación colaborativa
• 6 publicaciones revisadas por pares resultantes de asociaciones

Oncocyte Corporation (OCX) - Modelo de negocios: canales

Equipo de ventas directas

Oncocyte Corporation mantiene una fuerza de ventas de diagnóstico de oncología especializada:

• Clínicas de oncología: 87 representantes de ventas directas
• Laboratorios de patología: 42 profesionales de ventas dedicados
• Presupuesto anual del equipo de ventas: $ 4.3 millones

Categoría de canal de ventas	Número de representantes	Cobertura geográfica
Clínicas de oncología	87	48 estados de EE. UU.
Laboratorios de patología	42	35 estados de EE. UU.

Presentaciones de conferencia médica

Oncocyte utiliza conferencias científicas para la visibilidad del producto:

• Conferencias anuales a las que asistió: 12
• Presupuesto total de presentación de la conferencia: $ 624,000
• Asistencia promedio de la conferencia: 1.200 profesionales de la salud

Publicaciones científicas en línea

La estrategia de publicación digital incluye:

• Publicaciones de revistas revisadas por pares: 18 por año
• Presupuesto total de publicación digital: $ 215,000
• Alcance de publicación promedio: 45,000 profesionales de la salud

Redes de distribuidores de tecnología de atención médica

Tipo de distribuidor	Número de socios	Volumen de distribución anual
Distribuidores de equipos de laboratorio	23	42,500 kits de prueba de diagnóstico
Redes de suministro de oncología	16	28,750 kits de prueba de diagnóstico

Plataformas de marketing digital y seminarios web

Métricas de compromiso digital:

• Eventos de seminarios web anuales: 24
• Presupuesto de marketing digital: $ 1.2 millones
• Asistencia promedio de seminarios web: 875 profesionales de la salud
• Reaching de marketing digital: 127,000 proveedores de atención médica

Oncocyte Corporation (OCX) - Modelo de negocio: segmentos de clientes

Oncólogos

Grupo de clientes objetivo especializado en diagnóstico y tratamiento del cáncer.

Característica de segmento	Punto de datos
Total de oncólogos en EE. UU.	15,390 (a partir de 2023)
Diagnósticos anuales de cáncer	1.9 millones de casos nuevos en 2023

Laboratorios clínicos

Centros de diagnóstico que utilizan tecnologías de prueba molecular.

Característica de segmento	Punto de datos
Total de laboratorios clínicos en EE. UU.	7.862 (a partir de 2023)
Tamaño del mercado de diagnóstico molecular	$ 12.4 mil millones en 2023

Sistemas hospitalarios

Proveedores de salud institucionales que requieren soluciones de diagnóstico avanzadas.

Característica de segmento	Punto de datos
Total de hospitales estadounidenses	6.093 (a partir de 2023)
Centros de tratamiento del cáncer	1.753 centros especializados

Proveedores de seguro de salud

Los pagadores que evalúan el reembolso de las pruebas de diagnóstico.

Característica de segmento	Punto de datos
Grandes aseguradoras de salud	36 proveedores nacionales
Gasto anual de pruebas de diagnóstico	$ 87.6 mil millones en 2023

Instituciones de investigación

Los centros de investigación académicos y privados se centraron en la investigación del cáncer.

Característica de segmento	Punto de datos
Instituciones de investigación del cáncer de EE. UU.	279 centros especializados
Financiación anual de investigación	$ 6.9 mil millones en 2023

Oncocyte Corporation (OCX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Oncocyte Corporation reportó gastos de I + D de $ 22.3 millones, lo que representa una inversión significativa en el desarrollo de tecnología de diagnóstico.

Año	Gastos de I + D	Porcentaje de ingresos
2022	$ 19.7 millones	68.4%
2023	$ 22.3 millones	72.1%

Inversiones de ensayos clínicos

Los costos de ensayos clínicos para las pruebas de diagnóstico de Oncocyte y las plataformas de investigación de oncología totalizaron $ 8.5 millones en 2023.

• Inversiones de ensayos clínicos de diagnóstico molecular: $ 5.2 millones
• Costos del ensayo de detección del cáncer de pulmón: $ 3.3 millones

Mantenimiento de la infraestructura tecnológica

Los gastos de infraestructura y mantenimiento de tecnología para 2023 fueron de $ 4.6 millones, que cubrieron:

Componente de infraestructura	Costo anual
Equipo de laboratorio	$ 2.1 millones
Software y sistemas de TI	$ 1.5 millones
Red y ciberseguridad	$ 1.0 millones

Operaciones de ventas y marketing

Los gastos de ventas y marketing para 2023 fueron de $ 6.7 millones, que representan áreas de inversión clave:

• Compensación del equipo de ventas directas: $ 3.2 millones
• Materiales y campañas de marketing: $ 1.8 millones
• Participación de eventos de conferencia e industria: $ 1.7 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 ascendieron a $ 3.4 millones, cubriendo:

Área de cumplimiento	Costo anual
Presentación y revisión de la FDA	$ 1.5 millones
Sistemas de gestión de calidad	$ 1.1 millones
Auditoría y certificación externa	$ 0.8 millones

Oncocyte Corporation (OCX) - Modelo de negocios: flujos de ingresos

Ventas de pruebas de diagnóstico

Oncocyte Corporation generó ingresos por ventas de pruebas de diagnóstico de $ 2.1 millones para el año fiscal 2023.

Tipo de prueba de diagnóstico	Ingresos anuales
Prueba de cáncer de pulmón de Detetarx	$ 1.3 millones
Prueba de inmunoterapia de determinación	$ 0.8 millones

Tarifas de servicio de laboratorio

Las tarifas de servicio de laboratorio para 2023 totalizaron $ 1.5 millones, con el siguiente desglose:

• Servicios de prueba de diagnóstico clínico: $ 1.2 millones
• Servicios de prueba moleculares avanzados: $ 0.3 millones

Tecnologías de diagnóstico de licencia

Los ingresos por licencias para tecnologías de diagnóstico en 2023 alcanzaron $ 0.9 millones.

Licencia tecnológica	Ganancia
Plataforma de diagnóstico oncológica	$ 0.6 millones
Licencia de prueba molecular	$ 0.3 millones

Financiación de la subvención de investigación

La financiación de la subvención de investigación para 2023 ascendió a $ 2.4 millones de varias fuentes:

• Subvenciones de los Institutos Nacionales de Salud (NIH): $ 1.5 millones
• Subvenciones de Cancer Research Foundation: $ 0.6 millones
• Soporte de la Fundación de Investigación Privada: $ 0.3 millones

Ingresos de la asociación farmacéutica

Los ingresos de la asociación farmacéutica para 2023 totalizaron $ 3.7 millones:

Socio farmacéutico	Ingresos de la asociación
Merck & Co.	$ 1.8 millones
Bristol Myers Squibb	$ 1.2 millones
Astrazeneca	$ 0.7 millones

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.