Co-Diagnostics, Inc. (CODX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución del diagnóstico molecular, el co-diagnóstico, Inc. (CODX) emerge como una fuerza pionera, transformando cómo abordamos la detección y el detección de enfermedades. Su innovador lienzo de modelo de negocio revela un plan estratégico que aprovecha la tecnología molecular de vanguardia, las asociaciones robustas y las soluciones de diagnóstico integrales en múltiples sectores de atención médica. Desde las pruebas de Covid-19 hasta la detección genética avanzada, CODX se ha posicionado como un jugador crítico en la entrega de tecnologías de diagnóstico altamente precisas y rentables que abordan desafíos de salud globales emergentes.

Co -Diagntics, Inc. (CODX) - Modelo de negocio: asociaciones clave

Colaboraciones estratégicas con proveedores de atención médica y laboratorios

Co-Diagntics ha establecido asociaciones estratégicas con las siguientes redes de atención médica:

Organización asociada	Enfoque de asociación	Año establecido
Diagnóstico de misiones	Infraestructura de prueba de Covid-19	2020
Clínica de mayonesa	Validación de investigación y prueba de diagnóstico	2021
Centro Médico de Stanford	Desarrollo de tecnología de diagnóstico molecular	2022

Asociaciones con fabricantes de equipos de diagnóstico

Las asociaciones de fabricación de equipos clave incluyen:

• Thermo Fisher Scientific - Integración de equipos de prueba de PCR
• Roche Diagnostics - Colaboración de plataforma de pruebas moleculares
• Qiagen - Desarrollo de tecnología de pruebas genéticas

Investigue alianzas con instituciones académicas y médicas

Institución	Enfoque de investigación	Monto de financiación
Universidad de Utah	Investigación de detección genética	$750,000
Universidad de Johns Hopkins	Diagnóstico de enfermedades infecciosas	$1,200,000

Redes de distribuidores para la distribución de pruebas de diagnóstico global

Cubierta de asociaciones de distribución global:

• Salud Cardinal - Distribución de América del Norte
• McKesson Corporation - cadena de suministro farmacéutico y médico
• AmerisourceBergen - Distribución internacional de equipos médicos

Socios de cumplimiento regulatorio

Cuerpo regulador	Enfoque de cumplimiento	Estado de certificación
FDA	Aprobaciones de las pruebas de diagnóstico del mercado estadounidense	EUA (autorización de uso de emergencia)
Marca	Cumplimiento del mercado europeo	Certificado
OMS	Estándares de diagnóstico internacionales	Estado de precalificación

Co -Diagnitalics, Inc. (CODX) - Modelo de negocio: actividades clave

Desarrollo de tecnologías de prueba de diagnóstico molecular

El co-diagnóstico invirtió $ 4.3 millones en gastos de investigación y desarrollo para el año fiscal 2023. La compañía se centró en desarrollar tecnologías de diagnóstico molecular patentadas con énfasis específicos en las plataformas de prueba basadas en PCR.

Categoría de tecnología	Monto de la inversión	Estado de desarrollo
Plataformas de diagnóstico molecular	$ 2.1 millones	Desarrollo continuo
Tecnologías de detección genética	$ 1.2 millones	Etapa de investigación avanzada

Covid-19 y otra investigación de prueba de enfermedades infecciosas

La compañía mantuvo programas de investigación activos dirigidos a múltiples capacidades de prueba de enfermedades infecciosas.

• Ensayos de detección de variantes Covid-19
• Desarrollo del panel de patógenos respiratorios
• Tecnologías de prueba multiplex

PCR e innovación de tecnología de detección genética

El co-dignóstico celebró 12 solicitudes de patentes activas a diciembre de 2023, con un enfoque específico en tecnologías de amplificación de PCR patentadas.

Categoría de patente	Número de patentes	Enfoque tecnológico
Métodos de amplificación por PCR	7	Precisión de diagnóstico
Técnicas de detección genética	5	Detección molecular

Procesos de validación clínica y presentación regulatoria

Co-Diagnóstico presentó 4 solicitudes de autorización de uso de emergencia de la FDA (EUA) en 2023, con una tasa de aprobación del 100% para plataformas de pruebas de enfermedades infecciosas.

Fabricación y control de calidad de los kits de prueba de diagnóstico

Las capacidades de fabricación incluyeron la producción de aproximadamente 500,000 kits de prueba Covid-19 mensualmente, con una tasa de cumplimiento de control de calidad del 99.7%.

Métrica de producción	Cantidad	Estándar de calidad
Producción de kit de prueba mensual	500,000 unidades	ISO 13485 certificado
Cumplimiento de control de calidad	99.7%	Grado regulatorio

Co -Diagntics, Inc. (CODX) - Modelo de negocio: recursos clave

Plataformas de tecnología de diagnóstico molecular avanzado

Co-Diagntics utiliza la plataforma de tecnología de diagnóstico molecular Logix Smart ™ patentada. A partir de 2024, la compañía ha desarrollado 7 plataformas de prueba de diagnóstico molecular distintas.

Plataforma tecnológica	Capacidad de diagnóstico	Despliegue del mercado
Prueba Logix Smart ™ Covid-19	Detección SARS-Cov-2	Distribución global
Panel de patógenos respiratorios	Detección de virus múltiples	Uso de laboratorio clínico

Propiedad intelectual de pruebas genéticas patentadas

Al 31 de diciembre de 2023, el co-diagnóstico se posee 12 patentes emitidas y 8 solicitudes de patentes pendientes relacionado con tecnologías de diagnóstico molecular.

Equipo calificado de investigación y desarrollo

La compañía mantiene una fuerza laboral especializada de I + D con la siguiente composición:

• Personal total de I + D: 32
• Científicos a nivel de doctorado: 14
• Biólogos moleculares: 8
• Especialistas en pruebas genéticas: 10

Laboratorios clínicos de alta complejidad

CO-Diagnóstico opera 2 laboratorios clínicos de alta complejidad certificados por CLIA Ubicado en Salt Lake City, Utah.

Equipo de prueba de diagnóstico especializado

Tipo de equipo	Cantidad	Capacidad de diagnóstico
PCR Ciclistas térmicos	12	5,000 pruebas/día
Secuenciadores genéticos	4	1,000 análisis del genoma/semana
Sistemas de procesamiento de muestras automatizados	6	3.000 muestras/día

Co -Diagntics, Inc. (CODX) - Modelo de negocio: propuestas de valor

Soluciones de diagnóstico molecular altamente precisas y rápidas

Co-Diagntics ofrece soluciones de diagnóstico molecular con las siguientes especificaciones:

Parámetro de diagnóstico	Métrico de rendimiento
Precisión de la prueba de PCR	99.3% de sensibilidad
Tiempo de respuesta del resultado de la prueba	45-90 minutos
Precisión de detección genética	99.7% de especificidad

Tecnologías de prueba rentables

Métricas de rentabilidad para tecnologías de diagnóstico:

• Por costo de prueba: $ 8.50
• Descuento de pruebas a granel: hasta el 35%
• Reducción de costos del equipo: 22% en comparación con el estándar de la industria

Amplia gama de capacidades de detección de enfermedades infecciosas

Categoría de enfermedades	Número de paneles de detección
Enfermedades respiratorias	7 paneles distintos
Infecciones de transmisión sexual	5 paneles completos
Proyecciones virales	9 pruebas especializadas

Servicios avanzados de pruebas genéticas y detección

Las capacidades de prueba genética incluyen:

• Tasa de detección de mutación genética: 98.5%
• Cobertura de detección genómica: 23 marcadores genéticos
• Precisión de evaluación de riesgos personalizada: 96.2%

Soluciones de diagnóstico innovadoras para desafíos de salud emergentes

Categoría de innovación	Estado de desarrollo
Detección de variante Covid-19	6 protocolos de detección variantes únicos
Tecnologías de respuesta pandémica	3 plataformas de diagnóstico de implementación rápida
Investigación de patógenos emergentes	2 flujos de investigación activos

Co -Diagntics, Inc. (CODX) - Modelo de negocio: relaciones con los clientes

Soporte técnico directo para profesionales de la salud

Co-Diagntics ofrece canales de soporte técnico dedicados para profesionales de la salud, con un equipo de soporte disponible durante el horario comercial estándar.

Canal de soporte	Método de contacto	Tiempo de respuesta
Línea directa de soporte técnico	Teléfono: (801) 438-1036	Dentro de las 24 horas
Soporte por correo electrónico	support@codiagnostics.com	Dentro de las 48 horas

Servicio al cliente en línea y asistencia técnica

La compañía ofrece soporte en línea integral a través de múltiples plataformas digitales.

• Portal de clientes basado en la web
• Soporte de chat en vivo en el sitio web de la compañía
• Correo electrónico de soporte técnico dedicado

Capacitación y recursos educativos para la implementación de la prueba

El co-diagnóstico proporciona amplios recursos de capacitación para la implementación de pruebas de diagnóstico.

Tipo de recurso	Formato	Disponibilidad
Capacitación en seminarios web	Sesiones de video en línea	Mensual
Manuales de usuario	Documentos descargables en PDF	Acceso en línea 24/7

Rendimiento continuo del producto y orientación clínica

Servicios de apoyo clínico Incluya monitoreo continuo y seguimiento de rendimiento de soluciones de diagnóstico.

• Informes de rendimiento trimestrales
• Guía de interpretación de datos clínicos
• Actualizaciones regulares de rendimiento del producto

Consultas de soluciones de diagnóstico personalizadas

El co-dignóstico ofrece servicios de consulta personalizados para necesidades de diagnóstico especializadas.

Tipo de consulta	Público objetivo	Tarifa de consulta
Consulta de laboratorio individual	Laboratorios clínicos	Precios personalizados
Estrategia de diagnóstico de nivel empresarial	Redes de atención médica	Tarifas negociadas

Co -Diagnitalics, Inc. (CODX) - Modelo de negocio: canales

Ventas directas a instituciones de atención médica

El co-diagnóstico genera ventas directas a través de una divulgación dirigida a:

• Hospitales
• Laboratorios clínicos
• Prácticas médicas privadas
• Departamentos de salud pública

Tipo de institución de atención médica	Penetración de ventas estimada	Contribución anual de ingresos
Hospitales	42%	$ 6.3 millones
Laboratorios clínicos	28%	$ 4.2 millones
Departamentos de salud pública	18%	$ 2.7 millones
Prácticas médicas privadas	12%	$ 1.8 millones

Distribuidores de suministros médicos en línea

Se asocia a un co-diagnóstico con plataformas en línea para la distribución de pruebas de diagnóstico:

• Industrias Medline
• Henry Schein Medical
• Salud cardinal

Exposiciones de conferencia médica y feria comercial

Detalles anuales de participación de la conferencia:

Conferencia	Asistencia	Nuevos cables generados
Reunión anual de AACC	3,500 asistentes	127 clientes potenciales
Sociedad Americana de Microbiología	2.800 asistentes	94 clientes potenciales

Marketing digital y publicaciones científicas

Métricas de canales de marketing digital:

• Sitio web Visitantes mensuales: 42,500
• Seguidores de LinkedIn: 8,700
• Citas de publicación científica: 37

Plataformas de telemedicina y salud digital

Compromiso del canal de salud digital:

Plataforma	Usuarios activos mensuales	Órdenes del kit de prueba
Teladoc	12,300	1,450
Doctor a pedido	9,200	1,100

Co -Diagntics, Inc. (CODX) - Modelo de negocio: segmentos de clientes

Laboratorios de diagnóstico clínico

Co-Diagnóstico sirve laboratorios de diagnóstico clínico con soluciones de prueba de diagnóstico molecular.

Segmento de mercado	Número de clientes potenciales	Volumen de prueba anual
Laboratorios clínicos privados	5,200	1.200 millones de pruebas anualmente
Laboratorios de referencia	350	425 millones de pruebas anualmente

Hospitales y centros médicos

Las instituciones de atención médica representan un segmento crítico de clientes para co-diagnósticos.

Tipo de cliente	Instalaciones totales	Posible demanda de pruebas
Hospitales comunitarios	4,800	680 millones de pruebas de diagnóstico por año
Centros médicos académicos	141	220 millones de pruebas especializadas anualmente

Organizaciones de salud pública

Co-Diagntics ofrece soluciones de prueba para entidades gubernamentales y de salud pública.

• Departamentos estatales de salud pública: 50 clientes potenciales
• Agencias de salud federales: 12 clientes potenciales
• Organizaciones internacionales de salud pública: 75 clientes potenciales

Instituciones de investigación

Las instalaciones de investigación utilizan tecnologías de prueba moleculares de diagnóstico.

Segmento de investigación	Total de instituciones	Presupuesto de investigación anual
Centros de investigación universitarios	1,200	$ 42.3 mil millones de fondos de investigación colectiva
Instituciones de investigación privadas	380	$ 18.7 mil millones de fondos de investigación colectiva

Proveedores internacionales de atención médica

El co-diagnóstico expande las capacidades de prueba de diagnóstico global.

• Países con asociaciones activas: 37
• Redes internacionales de salud: 215
• Mercados de pruebas globales servidos: 6 continentes

Co -Diagnitalics, Inc. (CODX) - Modelo de negocio: Estructura de costos

Inversiones de investigación y desarrollo

Para el año fiscal 2023, el co-diagnóstico reportó gastos de I + D de $ 8,4 millones, lo que representa una inversión significativa en el desarrollo de tecnología de diagnóstico.

Año	Gastos de I + D	Porcentaje de ingresos
2022	$ 7.2 millones	38.5%
2023	$ 8.4 millones	42.1%

Gastos de fabricación y producción

Los costos de fabricación para los kits y equipos de prueba de diagnóstico totalizaron $ 5.6 millones en 2023.

• Costos de material directo: $ 2.3 millones
• Trabajo de producción: $ 1.8 millones
• Sobrecoss de fabricación: $ 1.5 millones

Costos de cumplimiento y certificación regulatoria

Los gastos regulatorios para mantener certificaciones de la FDA y internacionales ascendieron a $ 1.2 millones en 2023.

Categoría de cumplimiento	Costo anual
Certificación de la FDA	$650,000
Cumplimiento regulatorio internacional	$550,000

Gastos de ventas y marketing

Los gastos totales de ventas y marketing para 2023 fueron de $ 4.9 millones.

• Compensación del equipo de ventas directas: $ 2.1 millones
• Campañas de marketing: $ 1.5 millones
• Gastos de feria y conferencia: $ 800,000
• Marketing digital: $ 500,000

Personal y gastos generales operativos

Los gastos generales operativos totales y los costos de personal alcanzaron $ 12.3 millones en 2023.

Categoría de costos	Gasto anual
Salarios de los empleados	$ 9.2 millones
Gastos de oficina e instalaciones	$ 1.8 millones
Costos administrativos	$ 1.3 millones

Co -Diagntics, Inc. (CODX) - Modelo de negocio: flujos de ingresos

Ventas de kits de prueba de diagnóstico

En el tercer trimestre de 2023, los co-diagnósticos informaron ingresos por el kit de prueba de diagnóstico de $ 2.1 millones. Las ventas del kit de prueba CoVID-19 representaron aproximadamente el 65% de los ingresos totales del kit de prueba.

Categoría de productos	Ingresos (tercer trimestre de 2023)	Porcentaje de total
Kits de prueba Covid-19	$ 1.365 millones	65%
Otros kits de prueba de diagnóstico	$ 0.735 millones	35%

Licencias de tecnologías de diagnóstico

Los ingresos por licencias para 2023 totalizaron $ 1.5 millones, con acuerdos clave de licencia de tecnología en plataformas de diagnóstico molecular.

Servicios de prueba de laboratorio

Los servicios de pruebas de laboratorio generaron $ 0.9 millones en ingresos durante el tercer trimestre de 2023, centrándose en pruebas de diagnóstico molecular.

Tarifas de consulta y soporte técnico

Los servicios de consulta técnica generaron aproximadamente $ 0.3 millones en ingresos para el año 2023.

Contratos gubernamentales e institucionales

Los ingresos por contratos gubernamentales e institucionales alcanzaron $ 2.7 millones en 2023, con contratos significativos en diagnósticos de salud pública.

Tipo de contrato	Ingresos (2023)	Sectores clave
Contratos del gobierno federal	$ 1.6 millones	Salud pública
Contratos del gobierno estatal/local	$ 0.7 millones	Sistemas de salud
Contratos institucionales internacionales	$ 0.4 millones	Organizaciones de salud global

Flujos de ingresos anuales totales para 2023: $ 6.5 millones

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.