Co-Diagnostics, Inc. (Codx): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução do diagnóstico molecular, a Co-Diagnostics, Inc. (CODX) surge como uma força pioneira, transformando como abordamos a detecção e triagem de doenças. Seu inovador modelo de negócios Canvas revela um plano estratégico que aproveita a tecnologia molecular de ponta, parcerias robustas e soluções de diagnóstico abrangentes em vários setores de saúde. Desde o teste CoVID-19 até a triagem genética avançada, a Codx se posicionou como um participante crítico na fornecimento de tecnologias de diagnóstico altamente precisas e econômicas que abordam desafios emergentes à saúde global.

Co -Diagnostics, Inc. (Codx) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com profissionais de saúde e laboratórios

A co-diagnóstico estabeleceu parcerias estratégicas com as seguintes redes de assistência médica:

Organização parceira	Foco em parceria	Ano estabelecido
Diagnostics de missão	Infraestrutura de teste COVID-19	2020
Clínica Mayo	Validação de pesquisa e teste de diagnóstico	2021
Stanford Medical Center	Desenvolvimento de Tecnologia de Diagnóstico Molecular	2022

Parcerias com fabricantes de equipamentos de diagnóstico

As parcerias de fabricação de equipamentos -chave incluem:

• Thermo Fisher Scientific - PCR Testing Equipment Integration
• Roche Diagnostics - Colaboração da plataforma de teste molecular
• Qiagen - Desenvolvimento de tecnologia de teste genético

Pesquise alianças com instituições acadêmicas e médicas

Instituição	Foco na pesquisa	Valor de financiamento
Universidade de Utah	Pesquisa de triagem genética	$750,000
Universidade Johns Hopkins	Diagnóstico de doenças infecciosas	$1,200,000

Redes de distribuidores para distribuição de testes de diagnóstico global

Cobrir parcerias de distribuição global:

• Cardinal Health - distribuição norte -americana
• McKesson Corporation - Cadeia de suprimentos farmacêuticos e médicos
• Amerisourcebergen - distribuição internacional de equipamentos médicos

Parceiros de conformidade regulatória

Órgão regulatório	Foco de conformidade	Status de certificação
FDA	Aprovações de teste de diagnóstico do mercado dos EUA	EUA (autorização de uso de emergência)
Mark CE	Conformidade no mercado europeu	Certificado
QUEM	Padrões de diagnóstico internacionais	Status de pré -qualificação

Co -Diagnostics, Inc. (CodX) - Modelo de Negócios: Atividades -chave

Desenvolvimento de tecnologias de teste de diagnóstico molecular

A co-diagnóstico investiu US $ 4,3 milhões em despesas de pesquisa e desenvolvimento para o ano fiscal de 2023. A Companhia se concentrou no desenvolvimento de tecnologias de diagnóstico molecular proprietário com ênfase específica em plataformas de teste baseadas em PCR.

Categoria de tecnologia	Valor do investimento	Status de desenvolvimento
Plataformas de diagnóstico molecular	US $ 2,1 milhões	Desenvolvimento contínuo
Tecnologias de triagem genética	US $ 1,2 milhão	Estágio de pesquisa avançada

CoVID-19 e outras pesquisas sobre testes de doenças infecciosas

A empresa manteve programas de pesquisa ativos direcionados a várias capacidades de teste de doenças infecciosas.

• Ensaios de detecção de variantes covid-19
• Desenvolvimento de painel de patógenos respiratórios
• Tecnologias de teste multiplex

PCR e inovação tecnológica de triagem genética

A co-diagnóstico realizou 12 pedidos de patentes ativos em dezembro de 2023, com foco específico nas tecnologias de amplificação de PCR proprietárias.

Categoria de patentes	Número de patentes	Foco em tecnologia
Métodos de amplificação por PCR	7	Precisão diagnóstica
Técnicas de triagem genética	5	Detecção molecular

Validação clínica e processos de envio regulatório

A co-diagnóstico apresentou 4 aplicativos de autorização de uso de emergência da FDA (UEA) em 2023, com uma taxa de aprovação de 100% para plataformas de teste de doenças infecciosas.

Controle de fabricação e qualidade dos kits de teste de diagnóstico

As capacidades de fabricação incluíram a produção de aproximadamente 500.000 kits de teste CoVid-19 mensalmente, com uma taxa de conformidade de controle de qualidade de 99,7%.

Métrica de produção	Quantidade	Padrão de qualidade
Produção de kit de teste mensal	500.000 unidades	Certificado ISO 13485
Conformidade com controle de qualidade	99.7%	Grau regulatório

Co -Diagnostics, Inc. (CodX) - Modelo de Negócios: Recursos -Principais

Plataformas avançadas de tecnologia de diagnóstico molecular

A co-diagnóstico utiliza a plataforma de tecnologia de diagnóstico molecular Logix Smart ™ SMART ™. A partir de 2024, a empresa desenvolveu 7 plataformas de teste de diagnóstico molecular distintas.

Plataforma de tecnologia	Capacidade de diagnóstico	Implantação de mercado
Teste Logix Smart ™ CoVID-19	Detecção SARS-CoV-2	Distribuição global
Painel de patógenos respiratórios	Detecção de vírus múltiplos	Uso do laboratório clínico

Propriedade intelectual de testes genéticos proprietários

Em 31 de dezembro de 2023, co-diagnóstico detém 12 patentes emitidas e 8 pedidos de patente pendente Relacionado às tecnologias de diagnóstico molecular.

Equipe de pesquisa e desenvolvimento qualificada

A empresa mantém uma força de trabalho especializada em P&D com a seguinte composição:

• Pessoal total de P&D: 32
• Cientistas do nível de doutorado: 14
• Biólogos moleculares: 8
• Especialistas em testes genéticos: 10

Laboratórios clínicos de alta complexidade

O co-diagnóstico opera 2 laboratórios clínicos de alta complexidade certificados pela CLIA Localizado em Salt Lake City, Utah.

Equipamento especializado de teste de diagnóstico

Tipo de equipamento	Quantidade	Capacidade de diagnóstico
Ciclistas térmicos de PCR	12	5.000 testes/dia
Sequenciadores genéticos	4	1.000 análises do genoma/semana
Sistemas de processamento de amostra automatizados	6	3.000 amostras/dia

Co -Diagnostics, Inc. (Codx) - Modelo de Negócios: Proposições de Valor

Soluções de diagnóstico moleculares altamente precisas e rápidas

A co-diagnóstico oferece soluções de diagnóstico molecular com as seguintes especificações:

Parâmetro de diagnóstico	Métrica de desempenho
Precisão do teste de PCR	99,3% de sensibilidade
Resultado de teste Tempo de resposta	45-90 minutos
Precisão de triagem genética	99,7% de especificidade

Tecnologias de teste econômicas

Métricas de eficiência de custos para tecnologias de diagnóstico:

• Por custo de teste: US $ 8,50
• Desconto de teste em massa: até 35%
• Redução do custo do equipamento: 22% em comparação com o padrão da indústria

Ampla gama de capacidades de triagem de doenças infecciosas

Categoria de doença	Número de painéis de triagem
Doenças respiratórias	7 painéis distintos
Infecções sexualmente transmissíveis	5 painéis abrangentes
Triações virais	9 testes especializados

Serviços avançados de teste genético e triagem

Os recursos de teste genético incluem:

• Taxa de detecção de mutação genética: 98,5%
• Cobertura de triagem genômica: 23 marcadores genéticos
• Precisão de avaliação de risco personalizada: 96,2%

Soluções de diagnóstico inovadoras para desafios emergentes de saúde

Categoria de inovação	Status de desenvolvimento
Detecção da variante Covid-19	6 protocolos de triagem variantes exclusivos
Tecnologias de resposta pandêmica	3 plataformas de diagnóstico de implantação rápida
Pesquisa emergente de patógenos	2 fluxos de pesquisa ativos

Co -Diagnostics, Inc. (Codx) - Modelo de Negócios: Relacionamentos do Cliente

Suporte técnico direto para profissionais de saúde

A co-diagnóstico fornece canais de suporte técnico dedicados para profissionais de saúde, com uma equipe de suporte disponível durante o horário comercial padrão.

Canal de suporte	Método de contato	Tempo de resposta
Suporte técnico Linha direta	Telefone: (801) 438-1036	Dentro de 24 horas
Suporte por e -mail	support@codiagnostics.com	Dentro de 48 horas

Atendimento ao cliente on -line e assistência técnica

A empresa oferece suporte on -line abrangente por meio de várias plataformas digitais.

• Portal de clientes baseado na Web
• Suporte ao bate -papo ao vivo no site da empresa
• Email de suporte técnico dedicado

Treinamento e recursos educacionais para implementação de testes

A co-diagnóstico fornece recursos de treinamento extensos para a implementação de testes de diagnóstico.

Tipo de recurso	Formatar	Disponibilidade
Treinamento de on -line	Sessões de vídeo online	Mensal
Manuais do usuário	Documentos para download do PDF	24/7 de acesso online

Desempenho em andamento do produto e orientação clínica

Serviços de apoio clínico Inclua monitoramento contínuo e rastreamento de desempenho de soluções de diagnóstico.

• Relatórios trimestrais de desempenho
• Orientação de interpretação de dados clínicos
• Atualizações regulares de desempenho do produto

Consultas de solução de diagnóstico personalizadas

A co-diagnóstico oferece serviços de consulta personalizados para necessidades de diagnóstico especializadas.

Tipo de consulta	Público -alvo	Taxa de consulta
Consulta de laboratório individual	Laboratórios Clínicos	Preços personalizados
Estratégia de diagnóstico no nível da empresa	Redes de saúde	Taxas negociadas

Co -Diagnostics, Inc. (CodX) - Modelo de Negócios: Canais

Vendas diretas para instituições de saúde

O co-diagnóstico gera vendas diretas por meio de divulgação direcionada para:

• Hospitais
• Laboratórios Clínicos
• Práticas médicas privadas
• Departamentos de Saúde Pública

Tipo de instituição de saúde	Penetração estimada de vendas	Contribuição anual da receita
Hospitais	42%	US $ 6,3 milhões
Laboratórios Clínicos	28%	US $ 4,2 milhões
Departamentos de Saúde Pública	18%	US $ 2,7 milhões
Práticas médicas privadas	12%	US $ 1,8 milhão

Distribuidores de suprimentos médicos online

Co-diagnóstico parceira com plataformas on-line para distribuição de testes de diagnóstico:

• Medline Industries
• Henry Schein Medical
• Cardinal Health

Exposições de conferência médica e feira

Detalhes anuais da participação na conferência:

Conferência	Participação	Novos leads gerados
AACC Reunião Anual	3.500 participantes	127 clientes em potencial
Sociedade Americana de Microbiologia	2.800 participantes	94 clientes em potencial

Marketing Digital e Publicações Científicas

Métricas de canal de marketing digital:

• Website Visitantes mensais: 42.500
• Seguidores do LinkedIn: 8.700
• Citações de publicação científica: 37

Plataformas de telemedicina e saúde digital

Engajamento do canal de saúde digital:

Plataforma	Usuários ativos mensais	Ordens do kit de teste
Teladoc	12,300	1,450
Médico sob demanda	9,200	1,100

Co -Diagnostics, Inc. (Codx) - Modelo de negócios: segmentos de clientes

Laboratórios de Diagnóstico Clínico

O co-diagnóstico serve laboratórios clínicos de diagnóstico com soluções de teste de diagnóstico molecular.

Segmento de mercado	Número de clientes em potencial	Volume de teste anual
Laboratórios Clínicos Privados	5,200	1,2 bilhão de testes anualmente
Laboratórios de referência	350	425 milhões de testes anualmente

Hospitais e centros médicos

As instituições de saúde representam um segmento crítico de clientes para co-diagnóstico.

Tipo de cliente	Total de instalações	Demanda potencial de teste
Hospitais comunitários	4,800	680 milhões de testes de diagnóstico por ano
Centros Médicos Acadêmicos	141	220 milhões de testes especializados anualmente

Organizações de Saúde Pública

A co-diagnóstico fornece soluções de teste para entidades governamentais e de saúde pública.

• Departamentos de Saúde Pública do Estado: 50 clientes em potencial
• Agências de saúde federais: 12 clientes em potencial
• Organizações internacionais de saúde pública: 75 clientes em potencial

Instituições de pesquisa

As instalações de pesquisa utilizam tecnologias de testes moleculares de co-diagnóstico.

Segmento de pesquisa	Total de instituições	Orçamento de pesquisa anual
Centros de Pesquisa Universitária	1,200	US $ 42,3 bilhões de financiamento de pesquisa coletiva
Instituições de Pesquisa Privada	380	US $ 18,7 bilhões de financiamento de pesquisa coletiva

Provedores internacionais de saúde

A co-diagnóstico expande os recursos globais de teste de diagnóstico.

• Países com parcerias ativas: 37
• Redes Internacionais de Saúde: 215
• Mercados de testes globais servidos: 6 continentes

Co -diagnostics, Inc. (Codx) - Modelo de negócios: estrutura de custos

Investimentos de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a co-diagnóstico registrou despesas de P&D de US $ 8,4 milhões, representando um investimento significativo no desenvolvimento de tecnologia de diagnóstico.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 7,2 milhões	38.5%
2023	US $ 8,4 milhões	42.1%

Despesas de fabricação e produção

Os custos de fabricação de kits e equipamentos de teste de diagnóstico totalizaram US $ 5,6 milhões em 2023.

• Custos de material direto: US $ 2,3 milhões
• Trabalho de produção: US $ 1,8 milhão
• Mercancada de fabricação: US $ 1,5 milhão

Custos de conformidade e certificação regulatórios

As despesas regulatórias para manter as certificações FDA e internacionais totalizaram US $ 1,2 milhão em 2023.

Categoria de conformidade	Custo anual
Certificação FDA	$650,000
Conformidade regulatória internacional	$550,000

Despesas de vendas e marketing

As despesas totais de vendas e marketing para 2023 foram de US $ 4,9 milhões.

• Compensação da equipe de vendas direta: US $ 2,1 milhões
• Campanhas de marketing: US $ 1,5 milhão
• Feira de feira e despesas da conferência: US $ 800.000
• Marketing digital: US $ 500.000

Pessoal e sobrecarga operacional

Os custos de sobrecarga operacional e pessoal total atingiram US $ 12,3 milhões em 2023.

Categoria de custo	Despesa anual
Salários dos funcionários	US $ 9,2 milhões
Despesas de escritório e instalação	US $ 1,8 milhão
Custos administrativos	US $ 1,3 milhão

Co -Diagnostics, Inc. (Codx) - Modelo de negócios: fluxos de receita

Vendas de kits de teste de diagnóstico

No terceiro trimestre de 2023, a co-diagnóstico relatou receita de kit de teste de diagnóstico de US $ 2,1 milhões. As vendas do kit de teste CoVID-19 representaram aproximadamente 65% da receita total do kit de teste.

Categoria de produto	Receita (Q3 2023)	Porcentagem de total
Kits de teste covid-19	US $ 1,365 milhão	65%
Outros kits de teste de diagnóstico	US $ 0,735 milhão	35%

Licenciamento de tecnologias de diagnóstico

As receitas de licenciamento de 2023 totalizaram US $ 1,5 milhão, com os principais acordos de licenciamento de tecnologia em plataformas de diagnóstico molecular.

Serviços de teste de laboratório

Os serviços de teste de laboratório geraram US $ 0,9 milhão em receita durante o terceiro trimestre de 2023, com foco em testes de diagnóstico molecular.

Taxas de consulta e suporte técnico

Os serviços de consulta técnica geraram aproximadamente US $ 0,3 milhão em receita para o ano de 2023.

Contratos governamentais e institucionais

As receitas do contrato governamental e institucional atingiram US $ 2,7 milhões em 2023, com contratos significativos em diagnóstico de saúde pública.

Tipo de contrato	Receita (2023)	Setores -chave
Contratos do governo federal	US $ 1,6 milhão	Saúde pública
Contratos do governo estadual/local	US $ 0,7 milhão	Sistemas de saúde
Contratos institucionais internacionais	US $ 0,4 milhão	Organizações Globais de Saúde

Fluxos anuais totais de receita para 2023: US $ 6,5 milhões

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Value Propositions

Accessible and affordable real-time PCR testing at PoC/Home

The commercial targeting for the Co-Diagnostics, Inc. (CODX) instrument pricing is aimed at $300-$500 based on scale, with test cups priced at $15-$20 in developed markets, and lower pricing planned for LMICs (Least Developed Countries). As of September 30, 2025, the Company held $11.4 million in cash, cash equivalents, and marketable securities, following recent fundraising efforts that brought in approximately $10.8 million gross proceeds across two Registered Direct Offerings in the last two months before that date.

Gold standard PCR accuracy via proprietary Co-Primers® technology

The proprietary Co-Primers® technology has been supported by scientific analysis, such as the in-silico confirmation of high homology for chikungunya virus (CHIKV) primers against over 1,200 CHIKV sequences. The Co-Dx PCR platform remains subject to review by the U.S. Food and Drug Administration (FDA) and other regulatory bodies and was not yet available for sale as of the third quarter of 2025 report.

Rapid results in approximately 30 minutes for timely treatment decisions

While the specific turnaround time is not explicitly quantified in recent reports, the development focus is on point-of-care (PoC) testing using the compact Co-Dx PCR Pro™ instrument, with clinical evaluations for the upper respiratory multiplex test initiated on November 18, 2025, to support a U.S. FDA 510(k) submission.

Multiplex testing for simultaneous detection (e.g., Flu A/B, COVID-19, RSV)

Co-Diagnostics, Inc. (CODX) has begun clinical evaluations for its upper respiratory multiplex point-of-care test kit, which simultaneously detects four pathogens. The Company is also advancing other pipeline tests.

• The enhanced COVID-19 test is planned as the first of four infectious disease PCR test panels for regulatory submission.
• The multiplex RT-PCR test detects Influenza A, Influenza B, COVID-19, and RSV.
• Clinical studies for the Tuberculosis (TB) test are scheduled in India and South Africa in H2 2025 for CDSCO and SAHPRA submissions.

Simplified, video-guided workflow via a smartphone application

The Company announced the formation of a new artificial intelligence (AI) business unit to integrate existing and planned AI applications into the Co-Dx™ Primer Ai™ platform. Furthermore, a proprietary sample preparation instrument was developed to streamline and simplify the workflow for the PoC Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test.

Key Financial and Operational Metrics as of Late 2025:

Metric	Value (Q3 2025 End Date)	Value (Q2 2025 End Date)
Revenue	$0.1 million	$0.2 million
Net Loss	$5.9 million	$7.7 million
Operating Expenses	$7.1 million	$8.2 million
Cash, Cash Equivalents, and Marketable Securities	$11.4 million	$13.4 million
Research and Development Expense	$4.5 million	$4.7 million

The focus on operational efficiency is evident in the expense reduction: Operating expenses for Q3 2025 were 32.6% lower year-over-year, decreasing from approximately $10.6 million in Q3 2024 to $7.1 million in Q3 2025. The net loss per fully diluted share for Q3 2025 was $0.16, an improvement from $0.32 in Q3 2024.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Customer Relationships

You're looking at Co-Diagnostics, Inc. (CODX) in late 2025, and the customer relationship structure is heavily weighted toward building future commercial channels rather than servicing a large installed base of paying customers for the core platform right now. The entire thesis rests on the successful, timely launch of the Co-Dx PCR Home platform, which is still pending regulatory review by the FDA and/or other regulatory bodies and is not currently for sale.

Dedicated B2B sales and support for institutional/clinic users is currently focused on pre-commercial engagement, which means building the pipeline for when the platform launches, expected in 2026. The company is actively engaging with potential customers and training clinical evaluation sites for its pipeline tests, such as the Upper Respiratory Multiplex Test, which is designed to detect flu A, flu B, COVID-19, and RSV simultaneously.

Strategic partnership management is a major focus, as the company leans on joint ventures for international market entry. You see this clearly in the structure:

• CoMira Diagnostics: New JV with Arabian Eagle Manufacturing covering KSA and 18 MENA nations.
• CoSara Diagnostics: The Indian JV, for which the company is engaging Maxim Group LLC to explore strategic alternatives, potentially a SPAC transaction, to unlock value.

Management stated they are 'very pleased with the performance of both entities'.

The app-driven, self-service model for the Co-Dx PCR Home platform is in the development and regulatory queue. Since the platform is not yet available for sale, there are no established self-service customer metrics to report; the relationship is currently one of anticipation and regulatory progress tracking, not transactional support. The company did receive recognition at the Utah Business 2025 Innovation Awards Summit for this platform in the Healthcare and Life Sciences category.

Regulatory and clinical support for partner-led market entry is intrinsically linked to the JV strategy. The company is advancing clinical evaluations for its pipeline tests, which is the tangible output of this support structure. For example, the company is advancing clinical evaluations for the upper respiratory multiplex test to support submission to the U.S. FDA.

Investor relations is focused on communicating the long-term platform commercialization strategy while managing the current capital-intensive phase. The financial reality of this investment phase is stark, as the company reported Q3 2025 revenue of only $0.1 million, with all revenue coming from product sales, as grant revenue was absent in that quarter (compared to $0.4 million in grant revenue in Q3 2024). The net loss for Q3 2025 was $5.9 million, an improvement from the $9.7 million loss in the prior year period. The cash position reflects the ongoing need for capital to fund this development; cash, cash equivalents, and marketable securities stood at $11.4 million as of September 30, 2025, following a subsequent Registered Direct Offering that raised gross proceeds of approximately $7.0 million.

Here's a quick look at the financial context surrounding these customer-facing development efforts for the first three quarters of 2025, showing the heavy investment required to build these future relationships:

Metric (as of Q3 2025 or Period End)	Value	Context
Q3 2025 Total Revenue	$0.1 million	Down from $0.6 million in Q3 2024.
Q3 2025 Net Loss	$5.9 million	Improved from $9.7 million loss in Q3 2024.
Q3 2025 Adjusted EBITDA Loss	$6.3 million	Reduced from $8.8 million loss in Q3 2024.
Cash, Cash Equivalents, Marketable Securities (Sept 30, 2025)	$11.4 million	Positioned for continued development.
Gross Proceeds from Subsequent RDO	$7.0 million	Raised after Q3 close to strengthen balance sheet.
Total Operating Expenses (Q3 2025)	$7.1 million	Decreased by 32.6% year-over-year from $10.6 million in Q3 2024.

The company is defintely managing spend carefully to bridge the gap to commercialization next year.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Channels

Direct sales force targeting U.S. physician offices and urgent care activity showed Sales and Marketing expenditures at approximately $0.6 million for the second quarter of 2025.

The Co-Dx PCR Pro instrument has a listed device cost of $500, with a price per test cited at $82.99 for the Co-Dx platform, compared to an antigen price per test of $20.

The platform's potential U.S. reach is mapped against the fact that 88.9% of the U.S. population lives within 5 miles of a point-of-care location.

The Co-Dx PCR platform, including the PCR Pro instrument, is noted as currently used in 19 US states.

The Co-Dx PCR Pro instrument is 6½" x 4½" x 6" and weighs 2 lbs.

Deployment numbers indicate over 200+ Co-Dx boxes have been deployed.

International distribution is anchored by two joint ventures, CoSara in India and CoMira in the Middle East/North Africa (MENA) region.

The CoMira Diagnostics joint venture, formed with Arabian Eagle Manufacturing, establishes a commercial presence in the Kingdom of Saudi Arabia (KSA) and 18 additional MENA markets, covering 19 total countries.

The CoSara Diagnostics joint venture is the subject of an engagement with Maxim Group LLC to pursue a strategic transaction, which may include a SPAC transaction.

The company reported Q3 2025 revenue of $0.1 million, with all revenue recognized from product sales, down from $0.6 million in Q3 2024.

The overall financial position as of September 30, 2025, included cash, cash equivalents, and marketable securities totaling $11.4 million.

The Co-Dx PCR at-home and point-of-care platform, which includes the mobile application, is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.

The mobile application, Co-Dx PCR Pro App, delivers results via cloud reporting in approximately 30 minutes from sample to result.

Direct regulatory submissions are in progress, with clinical evaluations initiated in November 2025 for the upper respiratory multiplex test to support a submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of the Co-Dx PCR Pro instrument.

Results from these clinical evaluations are also expected to support submissions to other regulators, including the Saudi Food and Drug Authority (SFDA).

The company withdrew its initial COVID-19 Test 510(k) application to the FDA in February 2025 to submit an enhanced version.

Here's a snapshot of the Q3 2025 financial context surrounding these channels:

Metric	Q3 2025 Amount	Q3 2024 Amount
Total Revenue	$0.1 million	$0.6 million
Net Loss	$5.9 million	$9.7 million
Operating Expenses	$7.1 million	(Not Directly Available)
Cash & Marketable Securities (End of Q)	$11.4 million (Sept 30, 2025)	(Not Directly Available)

The platform pipeline includes tests for:

• Upper respiratory multiplex test (Flu A/B, COVID-19, RSV)
• Mycobacterium Tuberculosis (MTB) Test
• Multiplex HPV test

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Customer Segments

You're looking at the customer base for Co-Diagnostics, Inc. (CODX) as of late 2025. The financial reality right now shows that product revenue for the quarter ending September 30, 2025, was $0.15 million, which missed analyst projections of $153,000 for that quarter. Total revenue for the last twelve months was $507.89K, a significant drop of -93.06% year-over-year. This context shows the current reliance on pre-commercial activities and existing revenue streams while the new platform ramps up.

Healthcare providers (physician offices, clinics, skilled nursing facilities)

In the United States, Co-Diagnostics, Inc. is specifically targeting physician offices and clinics as a point-of-care application for the Co-Dx PCR platform. Skilled nursing facilities and residential homes, which house vulnerable populations needing extensive testing, are also key targets. The company is pricing its instrument in a range of $300-$500, depending on the scale of the order. The associated test cups are priced between $15-$20 in developed markets.

International governments and public health organizations (India, MENA)

International markets are a major focus, particularly for regulatory pathways and adoption of tests like those for HPV and Tuberculosis (TB). The company has established operations in India through its joint venture, CoSara Diagnostics Pvt Ltd. Furthermore, in September 2025, Co-Diagnostics, Inc. signed a strategic Memorandum of Understanding (MOU) to explore a joint venture in the Kingdom of Saudi Arabia (KSA). This KSA venture aims to manufacture and distribute the Co-Dx™ PCR platform across the Middle East and North Africa (MENA) region. KSA has historically been one of the largest international markets for the company's Logix Smart® tests. Clinical evaluations to support submissions to the CDSCO (India) and SAHPRA (Africa) were anticipated to begin in 2025.

Here's a look at the key international market focus areas:

Region/Country	Strategic Activity/Status as of Late 2025	Historical Significance
India	Operations via JV CoSara Diagnostics Pvt Ltd	Regulatory pathway for new tests to follow areas of greatest need
Kingdom of Saudi Arabia (KSA)	MOU signed September 2025 for Joint Venture (JV)	One of the largest international markets for Logix Smart® tests
MENA (Middle East and North Africa)	JV aims for distribution and commercialization of Co-Dx IP	Target market for localized manufacturing and sales
Africa	Regulatory pathway for new tests to follow areas of greatest need	Target for clinical evaluations to support SAHPRA submissions

National pharmacy and retail chains for PoC/at-home sales

Co-Diagnostics, Inc. anticipates developing a presence in the US pharmacy market, noting that there are tens of thousands of pharmacies equipped to conduct testing. The company is working toward commercialization of its platform, which is designed for point-of-care use.

Diagnostic laboratories and reference labs

While not explicitly detailed with specific 2025 financial breakdowns, the company's core technology is based on a PCR platform designed for molecular diagnostics. The cloud-based analysis feature of the Co-Dx PCR Pro platform allows for de-identified epidemiological data to be made available to health departments at local, regional, national, or international levels.

Individual consumers for future at-home testing (PCR Home)

The company is actively seeking clearance for home use testing in the United States. The Co-Dx PCR Home™ is a component of the Co-Dx PCR platform that received recognition at the Utah Business 2025 Innovation Awards Summit in September 2025. Commercialization for the platform, which includes the home testing component, is currently expected in 2026, pending regulatory review by the FDA and other bodies.

The planned customer base for at-home sales includes:

• Individual consumers seeking accessible PCR testing.
• The platform is expected to be commercialized in 2026.
• Test cups for developed markets are priced between $15-$20.
• The platform includes the Co-Dx PCR Home™ and a mobile app.

Finance: review Q4 2025 cash burn projections against the $13.4 million cash position as of June 30, 2025.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Cost Structure

You're looking at the core spending that keeps Co-Diagnostics, Inc. running as it pushes its platform toward broader commercialization. The cost structure is heavily weighted toward getting the technology validated and approved.

Heavy investment in Research and Development (R&D) represents a significant portion of the cash burn. This spending fuels the development of the Co-Dx PCR platform and the various assays in the pipeline. For the third quarter of fiscal 2025, Research and development expense was reported at $4.5 million. That compares to $4.9 million in the same quarter of fiscal 2024, showing a slight reduction in R&D spend year-over-year, though it still consumes the majority of the operating budget.

Here's a quick look at how the major expense categories stacked up in Q3 2025 compared to the prior year:

Expense Category	Q3 2025 Amount	Q3 2024 Amount
Total Operating Expenses	$7.1 million	$10.6 million
Research and Development Expense	$4.5 million	$4.9 million

Operating expenses of approximately $7.1 million in Q3 2025 reflects a conscious effort toward operational efficiency, coming down from $10.6 million in Q3 2024. Honestly, managing this burn rate is key while the company is still pre-commercial for its core tests.

Costs associated with clinical trials and regulatory submissions are an immediate, forward-looking cost driver. Management indicated they anticipate beginning clinical evaluations for all four main tests-COVID-19, ABCR, tuberculosis, and HPV-during the remainder of the 2025 calendar year. Preparing for and executing these trials, plus the subsequent 510(k) applications for the COVID-19 and multiplex ABCR tests, demands significant financial outlay for site management, patient enrollment, and data processing.

For manufacturing and assembly costs for instruments and test kits, the structure is evolving through strategic partnerships. The formation of the CoMira Diagnostics joint venture with Arabian Eagle Manufacturing is intended to localize manufacturing, assembly, distribution, and commercialization across the KSA and 18 MENA nations. Principal manufacturing for tests and instruments is planned to occur at the domestic facility before completion at the upgraded CoSara manufacturing campus in India for that region's distribution.

General and administrative expenses for corporate overhead and legal make up the remainder of the total operating expenses after R&D is accounted for. If total OpEx was $7.1 million and R&D was $4.5 million in Q3 2025, the G&A and other operating costs were approximately $2.6 million for that quarter. This covers everything from executive salaries to legal fees associated with corporate structuring and intellectual property defense.

• R&D expense in Q3 2025 was $4.5 million.
• Total Operating Expenses in Q3 2025 were $7.1 million.
• Cash, cash equivalents, and marketable securities stood at $11.4 million as of September 30, 2025.
• Subsequent to the quarter end, gross proceeds of approximately $7.0 million were raised from a Registered Direct Offering.

Finance: draft 13-week cash view by Friday.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Co-Diagnostics, Inc. (CODX) as of late 2025, and it's clear the company is navigating a transition away from grant dependency toward product sales and capital raises to fund growth. Honestly, the numbers reflect a pivot point.

Product sales of diagnostic test kits and reagents formed the entirety of the recognized revenue for the third quarter of 2025. For the three months ending September 30, 2025, total revenue was reported at \$0.1 million. This compares to the prior year's Q3 2024 revenue of \$0.6 million, which included approximately \$0.4 million from grant revenue. So, in Q3 2025, all recognized revenue, that \$0.1 million, came directly from product sales.

Here's a quick look at the key financial data points relevant to revenue and capital generation around that time:

Revenue/Financing Stream	Q3 2025 Amount (USD)	Context/Period
Total Revenue	\$0.1 million	Period ended September 30, 2025
Grant Revenue	\$0	Q3 2025
Product Sales Revenue	\$0.1 million	Q3 2025, representing 100% of total revenue
Proceeds from Direct Offering (Sept 2025)	\$3.8 million (Gross)	Closed September 18, 2025
Proceeds from Direct Offering (Late Oct 2025)	\$7.0 million (Approximate)	Entered into around October 28, 2025
Total Strategic Offering Proceeds	\$10.8 million	Raised across two offerings in the last two months (prior to Nov 2025 earnings)
Cash, Cash Equivalents, & Marketable Securities	\$11.4 million	As of September 30, 2025

Sales of the Co-Dx PCR Pro and Co-Dx Home instruments are a key part of the product sales stream, though specific instrument sales revenue isn't broken out from the total \$0.1 million. The company is focused on market access through affordability for the PCR Pro device, aiming for a price point potentially as low as about \$300 to \$500. This pricing strategy is defintely important for driving adoption of the platform.

Potential grant funding was negligible in the third quarter. The company recognized \$0 in grant revenue for Q3 2025, a notable drop from the prior year period which included approximately \$0.4 million in grant revenue. Management indicated plans for seeking additional grant funding to support future capital requirements.

Licensing fees and royalties from international joint ventures, specifically CoSara Diagnostics in India and CoMira Diagnostics in the MENA region, are strategic, long-term revenue drivers. While the company is actively pursuing a SPAC transaction for CoSara and expanding commercial footprint with CoMira, the search results do not provide a specific revenue figure for licensing fees or royalties recognized from these ventures during Q3 2025.

The balance sheet was bolstered by proceeds from strategic direct offerings. Co-Diagnostics raised a total of \$10.8 million across two strategic direct offerings in the last two months leading up to the Q3 2025 report. This total is comprised of a registered direct offering that closed on September 18, 2025, for gross proceeds of approximately \$3.8 million at \$0.40 per share, and a subsequent offering announced around late October 2025 for approximately \$7 million at \$0.55 per share. These proceeds are earmarked for working capital and general corporate purposes.

The strategic focus areas tied to these revenue streams include:

• Advancing clinical evaluations for the upper respiratory multiplex test.
• Pursuing a SPAC transaction for the CoSara joint venture in India.
• Expanding commercial presence via the CoMira joint venture in 19 MENA nations.
• Integrating AI applications into the Co-Dx Primer Ai platform.
• Positioning the Co-Dx PCR Pro device for scale with target pricing of \$300-\$500.

Finance: draft 13-week cash view by Friday.