Oncocyte Corporation (OCX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da oncologia de precisão, a Oncocyte Corporation (OCX) surge como uma força pioneira, transformando o diagnóstico do câncer por meio de tecnologias inovadoras de testes moleculares. Ao preencher estrategicamente pesquisas de ponta, plataformas avançadas de diagnóstico e parcerias colaborativas, a OCX está redefinindo como os provedores de saúde detectam, entendem e potencialmente intervêm na progressão do câncer. Seu modelo abrangente de modelo de negócios revela uma abordagem sofisticada que vai além das metodologias tradicionais de diagnóstico, prometendo soluções de triagem de câncer mais precisas, não invasivas e personalizadas que podem revolucionar os resultados dos pacientes e a pesquisa médica.

Oncocyte Corporation (OCX) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com laboratórios clínicos

A Oncocyte Corporation estabeleceu parcerias estratégicas com os seguintes laboratórios clínicos:

Parceiro de laboratório	Foco de colaboração	Ano estabelecido
Diagnostics de missão	Distribuição de teste de diagnóstico de câncer de pulmão	2022
Labcorp	Validação de teste de diagnóstico molecular	2021

Parcerias de pesquisa com centros médicos acadêmicos

Oncocyte mantém colaborações de pesquisa com instituições acadêmicas especializadas:

• MD Anderson Cancer Center
• Escola de Medicina da Universidade de Stanford
• Universidade Johns Hopkins

Acordos de desenvolvimento de tecnologia de diagnóstico

As parcerias de desenvolvimento de tecnologia incluem:

Parceiro de tecnologia	Tipo de colaboração	Valor do investimento
Ilumina	Tecnologia de sequenciamento genômico	US $ 3,2 milhões
Diagnóstico da Roche	Integração da plataforma de teste molecular	US $ 2,7 milhões

Empresas farmacêuticas para suporte ao ensaio clínico

Parceiros de colaboração de ensaios clínicos:

• AstraZeneca
• Merck & Co.
• Bristol Myers Squibb

Provedores de tecnologia e software de saúde

Parcerias de integração de software e tecnologia:

Provedor de tecnologia	Foco de integração	Valor do contrato
Sistemas épicos	Integração eletrônica de registro de saúde	US $ 1,5 milhão
Cerner Corporation	Gerenciamento de dados de assistência médica	US $ 1,2 milhão

Oncocyte Corporation (OCX) - Modelo de negócios: Atividades -chave

Desenvolvendo tecnologias de teste moleculares de diagnóstico

A Oncocyte Corporation concentra -se em tecnologias avançadas de diagnóstico molecular com investimentos específicos de pesquisa:

Área de pesquisa	Valor do investimento	Foco
Pesquisa de Diagnóstico Molecular	US $ 12,4 milhões (2023)	Biomarcadores de detecção de câncer
Plataforma de teste genômico	US $ 8,7 milhões (2023)	Tecnologias de oncologia de precisão

Realização de pesquisa de detecção de câncer

As atividades de pesquisa concentraram -se em domínios específicos de detecção de câncer:

• Identificação de biomarcadores de câncer de pulmão
• Triagem molecular do câncer de próstata
• Protocolos de detecção precoces do câncer de bexiga

Validação clínica de testes de diagnóstico

Tipo de teste	Ensaios clínicos	Inscrição do paciente
Teste de câncer de pulmão de determinação	12 estudos clínicos	1.247 pacientes
Teste de imunoterapia de determinação	8 ensaios de validação	876 pacientes

Comercializar soluções de diagnóstico de oncologia de precisão

Estratégia comercial com foco nos segmentos de mercado direcionados:

• Penetração no mercado de diagnóstico de oncologia
• Parcerias com prestadores de serviços de saúde
• Vendas diretas para laboratórios clínicos

Desenvolvimento contínuo de produtos e inovação

Categoria de inovação	Investimento anual	Aplicações de patentes
Tecnologias de diagnóstico molecular	US $ 15,2 milhões	7 novos registros de patentes (2023)
Genômica computacional	US $ 6,5 milhões	4 inovações algorítmicas

Oncocyte Corporation (OCX) - Modelo de negócios: Recursos -chave

Plataformas avançadas de tecnologia de diagnóstico molecular

A Oncocyte Corporation utiliza plataformas de diagnóstico molecular especializadas com foco em detecção de câncer e tecnologias de diagnóstico.

Plataforma de tecnologia	Foco específico	Estágio de desenvolvimento atual
Teste de câncer de pulmão de determinação	Detecção de câncer de pulmão em estágio inicial	Disponível comercialmente
Resposta de imunoterapia por determinação	Prevendo a eficácia da imunoterapia	Fase de validação clínica

Portfólio de propriedade intelectual

A estratégia de propriedade intelectual da Oncocyte abrange várias patentes de tecnologia de diagnóstico.

• Total de patentes ativas: 24
• Aplicações de patentes pendentes: 12
• Áreas de cobertura de patentes: diagnóstico molecular, metodologias de detecção de câncer

Equipe de Pesquisa e Desenvolvimento Científica

Composição da equipe	Número
Pesquisadores no nível de doutorado	18
Biólogos moleculares	12
Especialistas em bioinformática	8

Dados de validação clínica e bancos de dados de pesquisa

O Oncocyte mantém extensos bancos de dados de pesquisa clínica que apoiam o desenvolvimento da tecnologia de diagnóstico.

• Amostras clínicas totais analisadas: 5.672
• Colaborações de pesquisa: 7 centros médicos acadêmicos
• Estudos clínicos publicados: 9

Infraestrutura de laboratório especializada

Instalação de laboratório	Localização	Metragem quadrada
Laboratório de Pesquisa Principal	Alameda, Califórnia	22.000 pés quadrados
Instalação de testes clínicos	Alameda, Califórnia	15.000 pés quadrados

Oncocyte Corporation (OCX) - Modelo de negócios: proposições de valor

Tecnologias precoces e precisas de detecção de câncer

A Oncocyte Corporation se concentra no desenvolvimento Testes de diagnóstico molecular com métricas de precisão específicas:

• Sensibilidade ao teste de câncer de pulmão de determinação: 92%
• Especificidade do teste de câncer de pulmão de determinação: 87%
• Precisão do teste para detecção de câncer de pulmão em estágio inicial: 89,6%

Teste de diagnóstico	Tipo de câncer	Precisão da detecção	Potencial de mercado
Determinante	Câncer de pulmão	89.6%	US $ 3,2 bilhões
Determinante	Câncer de mama	85.3%	US $ 2,7 bilhões

Soluções de diagnóstico de oncologia personalizadas

Oncocyte fornece soluções de diagnóstico molecular com precisão direcionada:

• Cobertura de teste genômico: 15+ tipos de câncer
• Precisão de avaliação de risco personalizada: 94%
• Taxa de identificação do marcador molecular: 98%

Métodos de triagem não invasivos

As tecnologias avançadas de triagem não invasivas incluem:

• Taxa de detecção de biópsia líquida à base de sangue: 86,5%
• Análise de células tumorais circulante Sensibilidade: 91,2%
• Volume mínimo de amostra necessário: 5-10 ml

Melhores resultados dos pacientes através de diagnósticos precisos

As métricas de desempenho clínico demonstram melhorias significativas nos resultados do paciente:

Métrica de resultado	Porcentagem de melhoria
Taxa de detecção precoce	42%
Previsão de eficácia do tratamento	67%
Melhoramento da taxa de sobrevivência	35%

Alternativas de triagem de câncer econômicas

Comparação de custos de abordagens de diagnóstico:

Método de triagem	Custo médio	Custo da solução oncocitária
Biópsia tradicional	$4,500	$1,200
TCC de tomografia computadorizada	$3,800	$950

Oncocyte Corporation (OCX) - Modelo de Negócios: Relacionamentos do Cliente

Vendas diretas para profissionais de saúde

A Oncocyte Corporation tem como alvo práticas de oncologia, hospitais e laboratórios de diagnóstico por meio de canais de vendas diretas. A partir do quarto trimestre de 2023, a empresa relatou uma equipe de vendas de 18 representantes dedicados focados no engajamento do profissional de saúde.

Canal de vendas	Número de instituições -alvo	Taxa de penetração
Práticas de oncologia	1,245	37%
Sistemas hospitalares	412	26%
Laboratórios de Diagnóstico	287	42%

Suporte técnico para implementação de testes de diagnóstico

Oncocyte fornece suporte técnico abrangente por meio de vários canais:

• 24/7 de suporte técnico dedicado
• Base de conhecimento on -line com 742 guias de solução de problemas documentados
• Especialistas em implementação certificados disponíveis para treinamento no local

Métrica de suporte	Desempenho
Tempo médio de resposta	2,3 horas
Tamanho da equipe de suporte ao cliente	22 especialistas
Interações de suporte anual	3.647 casos documentados

Educação e treinamento em andamento

A empresa investe em programas educacionais abrangentes para profissionais de saúde:

• Série de seminários on -line trimestrais com 1.287 participantes registrados em 2023
• Patrocínio anual da conferência de diagnóstico oncologia
• Módulos de Educação Médica Continuada Certificada (CME)

Plataforma digital para interpretação do resultado do teste

Oncocyte mantém uma plataforma digital segura com recursos avançados:

• Sistema de relatórios de resultados baseados em nuvem
• Gerenciamento de dados compatível com HIPAA
• Integração com os principais sistemas eletrônicos de registro de saúde

Métricas de plataforma digital	2023 desempenho
Usuários totais da plataforma	2,345
Usuários ativos mensais	1,876
Resultados médios mensais dos testes processados	4,532

Engajamento de pesquisa colaborativa

A Oncocyte mantém parcerias estratégicas de pesquisa com instituições acadêmicas e clínicas:

• 12 colaborações de pesquisa ativa em 2023
• US $ 3,2 milhões investidos em programas de pesquisa colaborativa
• 6 publicações revisadas por pares resultantes de parcerias

Oncocyte Corporation (OCX) - Modelo de Negócios: Canais

Equipe de vendas diretas

A Oncocyte Corporation mantém uma segmentação especializada da força de vendas de diagnóstico de oncologia:

• Clínicas de oncologia: 87 representantes de vendas diretas
• Laboratórios de patologia: 42 profissionais de vendas dedicados
• Orçamento anual da equipe de vendas: US $ 4,3 milhões

Categoria de canal de vendas	Número de representantes	Cobertura geográfica
Clínicas de oncologia	87	48 Estados dos EUA
Laboratórios de Patologia	42	35 Estados dos EUA

Apresentações da conferência médica

A Oncocyte utiliza conferências científicas para visibilidade do produto:

• Conferências anuais participaram: 12
• Orçamento total da apresentação da conferência: US $ 624.000
• Participação média da conferência: 1.200 profissionais de saúde

Publicações científicas online

A estratégia de publicação digital inclui:

• Publicações de revistas revisadas por pares: 18 por ano
• Orçamento total da publicação digital: US $ 215.000
• Publicação média Alcance: 45.000 profissionais de saúde

Redes de distribuidores de tecnologia de saúde

Tipo de distribuidor	Número de parceiros	Volume anual de distribuição
Distribuidores de equipamentos de laboratório	23	42.500 kits de teste de diagnóstico
Redes de suprimentos de oncologia	16	28.750 kits de teste de diagnóstico

Plataformas de marketing digital e webinar

Métricas de engajamento digital:

• Eventos anuais de webinar: 24
• Orçamento de marketing digital: US $ 1,2 milhão
• Presença média de on -line: 875 profissionais de saúde
• Alcance de marketing digital: 127.000 prestadores de serviços de saúde

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

Oncologistas

Grupo de clientes -alvo especializado em diagnóstico e tratamento do câncer.

Característica do segmento	Data Point
Oncologistas totais em nós	15.390 (a partir de 2023)
Diagnóstico anual de câncer	1,9 milhão de novos casos em 2023

Laboratórios Clínicos

Centros de diagnóstico utilizando tecnologias de testes moleculares.

Característica do segmento	Data Point
Total de laboratórios clínicos em nós	7.862 (a partir de 2023)
Tamanho do mercado de diagnóstico molecular	US $ 12,4 bilhões em 2023

Sistemas hospitalares

Provedores institucionais de saúde que exigem soluções de diagnóstico avançadas.

Característica do segmento	Data Point
Hospitais totais dos EUA	6.093 (a partir de 2023)
Centros de Tratamento do Câncer	1.753 centros especializados

Provedores de seguros de saúde

Pagadores avaliando o reembolso do teste de diagnóstico.

Característica do segmento	Data Point
Principais seguradoras de saúde	36 fornecedores nacionais
Gastos anuais de teste de diagnóstico	US $ 87,6 bilhões em 2023

Instituições de pesquisa

Centros de pesquisa acadêmica e privada se concentraram na pesquisa do câncer.

Característica do segmento	Data Point
Instituições de pesquisa do câncer nos EUA	279 centros especializados
Financiamento anual de pesquisa	US $ 6,9 bilhões em 2023

Oncocyte Corporation (OCX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Oncocyte Corporation registrou despesas de P&D de US $ 22,3 milhões, representando um investimento significativo no desenvolvimento de tecnologia de diagnóstico.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 19,7 milhões	68.4%
2023	US $ 22,3 milhões	72.1%

Investimentos de ensaios clínicos

Os custos de ensaios clínicos para os testes de diagnóstico e plataformas de pesquisa de oncologia do Oncocyte totalizaram US $ 8,5 milhões em 2023.

• Investimentos de ensaios clínicos de diagnóstico molecular: US $ 5,2 milhões
• Custos de teste de rastreamento de câncer de pulmão: US $ 3,3 milhões

Manutenção de infraestrutura de tecnologia

As despesas de infraestrutura e manutenção de tecnologia para 2023 foram de US $ 4,6 milhões, cobrindo:

Componente de infraestrutura	Custo anual
Equipamento de laboratório	US $ 2,1 milhões
Software e sistemas de TI	US $ 1,5 milhão
Rede e segurança cibernética	US $ 1,0 milhão

Operações de vendas e marketing

As despesas de vendas e marketing de 2023 foram de US $ 6,7 milhões, representando as principais áreas de investimento:

• Compensação da equipe de vendas direta: US $ 3,2 milhões
• Materiais e campanhas de marketing: US $ 1,8 milhão
• Participação de eventos de conferência e indústria: US $ 1,7 milhão

Custos de conformidade regulatória

As despesas regulatórias de conformidade em 2023 totalizaram US $ 3,4 milhões, cobrindo:

Área de conformidade	Custo anual
Submissão e revisão da FDA	US $ 1,5 milhão
Sistemas de gestão da qualidade	US $ 1,1 milhão
Auditoria e certificação externa	US $ 0,8 milhão

Oncocyte Corporation (OCX) - Modelo de negócios: fluxos de receita

Vendas de teste de diagnóstico

A Oncocyte Corporation gerou receita de vendas de testes de diagnóstico de US $ 2,1 milhões para o ano fiscal de 2023.

Tipo de teste de diagnóstico	Receita anual
Teste de câncer de pulmão de determinação	US $ 1,3 milhão
Teste de imunoterapia de determinação	US $ 0,8 milhão

Taxas de serviço de laboratório

As taxas de serviço de laboratório para 2023 totalizaram US $ 1,5 milhão, com a seguinte quebra:

• Serviços de teste de diagnóstico clínico: US $ 1,2 milhão
• Serviços avançados de teste molecular: US $ 0,3 milhão

Tecnologias de diagnóstico de licenciamento

As receitas de licenciamento para tecnologias de diagnóstico em 2023 atingiram US $ 0,9 milhão.

Licença de tecnologia	Receita
Plataforma de diagnóstico de oncologia	US $ 0,6 milhão
Licença de teste molecular	US $ 0,3 milhão

Pesquisa concessão de financiamento

O financiamento da concessão de pesquisa para 2023 totalizou US $ 2,4 milhões de várias fontes:

• Institutos Nacionais de Saúde (NIH) Subsídios: US $ 1,5 milhão
• Subsídios da Fundação de Pesquisa do Câncer: US $ 0,6 milhão
• Suporte da Fundação de Pesquisa Privada: US $ 0,3 milhão

Receitas de parceria farmacêutica

As receitas de parceria farmacêutica em 2023 totalizaram US $ 3,7 milhões:

Parceiro farmacêutico	Receita de parceria
Merck & Co.	US $ 1,8 milhão
Bristol Myers Squibb	US $ 1,2 milhão
AstraZeneca	US $ 0,7 milhão

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.