Codiagnostics, Inc. (CODX): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage en évolution rapide des diagnostics moléculaires, Co-Diagnostics, Inc. (CODX) émerge comme une force pionnière, transformant la façon dont nous abordons la détection et le dépistage des maladies. Leur toile de modèle commercial innovant révèle un plan stratégique qui exploite la technologie moléculaire de pointe, des partenariats robustes et des solutions de diagnostic complètes dans plusieurs secteurs de santé. Du test de Covid-19 au dépistage génétique avancé, CODX s'est positionné comme un acteur critique pour offrir des technologies de diagnostic très précises et rentables qui relèvent des défis de santé mondiaux émergents.

Codiagnostics, Inc. (CODX) - Modèle d'entreprise: partenariats clés

Collaborations stratégiques avec les prestataires de soins de santé et les laboratoires

Codiagnostics a établi des partenariats stratégiques avec les réseaux de soins de santé suivants:

Organisation partenaire	Focus de partenariat	Année établie
Diagnostics de quête	Infrastructure de test Covid-19	2020
Clinique de mayo	Validation des tests de recherche et de diagnostic	2021
Centre médical de Stanford	Développement de la technologie diagnostique moléculaire	2022

Partenariats avec les fabricants d'équipements de diagnostic

Les partenariats de fabrication d'équipements clés comprennent:

• Thermo Fisher Scientific - Intégration de l'équipement de test de PCR
• Roche Diagnostics - Collaboration de plate-forme de test moléculaire
• QIAGEN - Développement de la technologie des tests génétiques

Alliances de recherche avec des établissements universitaires et médicaux

Institution	Focus de recherche	Montant du financement
Université de l'Utah	Recherche de dépistage génétique	$750,000
Université Johns Hopkins	Diagnostics des maladies infectieuses	$1,200,000

Réseaux de distributeurs pour la distribution de tests de diagnostic mondial

Couverture des partenariats de distribution mondiale:

• Cardinal Health - Distribution nord-américaine
• McKesson Corporation - chaîne d'approvisionnement pharmaceutique et médicale
• Amerisourcebergen - Distribution internationale des équipements médicaux

Partenaires de conformité réglementaire

Corps réglementaire	Focus de la conformité	Statut de certification
FDA	Approbations de test de diagnostic du marché américain	EUA (Autorisation d'utilisation d'urgence)
Marque CE	Conformité au marché européen	Agréé
OMS	Normes de diagnostic international	Statut de préqualification

Codiagnostics, Inc. (CODX) - Modèle d'entreprise: Activités clés

Développement de technologies de test de diagnostic moléculaire

Les codiagnostics ont investi 4,3 millions de dollars dans les frais de recherche et de développement pour l'exercice 2023. La société s'est concentrée sur le développement de technologies de diagnostic moléculaire propriétaire en mettant l'accent sur les plateformes de test basées sur la PCR.

Catégorie de technologie	Montant d'investissement	Statut de développement
Plates-formes de diagnostic moléculaire	2,1 millions de dollars	Développement continu
Technologies de dépistage génétique	1,2 million de dollars	Étape de recherche avancée

Covid-19 et autres recherches sur les tests de maladies infectieuses

La société a maintenu des programmes de recherche actifs ciblant plusieurs capacités de test de maladies infectieuses.

• Essais de détection de variantes Covid-19
• Développement du panel de pathogènes respiratoire
• Technologies de test multiplex

PCR et technologie de dépistage génétique Innovation

Les codiagnostiques ont tenu 12 demandes de brevet actives en décembre 2023, en mettant spécifiquement l'accent sur les technologies propriétaires d'amplification par PCR.

Catégorie de brevet	Nombre de brevets	Focus technologique
Méthodes d'amplification PCR	7	Précision de diagnostic
Techniques de dépistage génétique	5	Détection moléculaire

Validation clinique et processus de soumission réglementaire

Les codiagnostics ont soumis 4 demandes d'autorisation d'urgence de la FDA (EUA) en 2023, avec un taux d'approbation de 100% pour les plateformes de test de maladies infectieuses.

Contrôle de fabrication et de qualité des kits de test de diagnostic

Les capacités de fabrication comprenaient la production d'environ 500 000 kits de test Covid-19 Covid-19 mensuellement, avec un taux de conformité du contrôle de la qualité de 99,7%.

Métrique de production	Quantité	Norme de qualité
Production de kit de test mensuel	500 000 unités	ISO 13485 certifié
Conformité au contrôle de la qualité	99.7%	Grade de réglementation

Codiagnostics, Inc. (CODX) - Modèle d'entreprise: Ressources clés

Plateformes de technologie de diagnostic moléculaire avancée

La co-diagnostic utilise la plateforme de technologie de diagnostic moléculaire Logix Smart ™ propriétaire. Depuis 2024, la société a développé 7 plates-formes de test de diagnostic moléculaire distinctes.

Plate-forme technologique	Capacité de diagnostic	Déploiement du marché
Test Covid-19 de Logix Smart ™	Détection SARS-COV-2	Distribution mondiale
Panel de pathogène respiratoire	Détection de virus multiple	Utilisation du laboratoire clinique

Propriété intellectuelle des tests génétiques propriétaires

Au 31 décembre 2023, les codiagnostiques tiennent 12 brevets délivrés et 8 demandes de brevet en instance liés aux technologies diagnostiques moléculaires.

Équipe de recherche et développement qualifiée

La société maintient une main-d'œuvre spécialisée de R&D avec la composition suivante:

• Personnel total de R&D: 32
• Scientifiques de niveau doctoral: 14
• Biologistes moléculaires: 8
• Spécialistes des tests génétiques: 10

Laboratoires cliniques à haute complexité

Les codiagnostics opèrent 2 laboratoires cliniques à haute complexité certifiés CLIA Situé à Salt Lake City, Utah.

Équipement de test de diagnostic spécialisé

Type d'équipement	Quantité	Capacité de diagnostic
PCR Thermal Cycler	12	5 000 tests / jour
Séquenceurs génétiques	4	1 000 analyses du génome / semaine
Systèmes de traitement des échantillons automatisés	6	3 000 échantillons / jour

Codiagnostics, Inc. (CODX) - Modèle d'entreprise: propositions de valeur

Solutions de diagnostic moléculaire très précises et rapides

La codiagnostic propose des solutions de diagnostic moléculaire avec les spécifications suivantes:

Paramètre de diagnostic	Métrique de performance
Précision du test PCR	Sensibilité à 99,3%
Temps de délai d'exécution du résultat	45-90 minutes
Précision de dépistage génétique	Spécificité de 99,7%

Technologies de test rentables

Métriques de rentabilité pour les technologies de diagnostic:

• Coût de test: 8,50 $
• Remise des tests en vrac: jusqu'à 35%
• Réduction des coûts de l'équipement: 22% par rapport à la norme de l'industrie

Large gamme de capacités de dépistage des maladies infectieuses

Catégorie de maladie	Nombre de panneaux de dépistage
Maladies respiratoires	7 panneaux distincts
Infections sexuellement transmissibles	5 panneaux complets
Projections virales	9 tests spécialisés

Services avancés de tests génétiques et de dépistage

Les capacités de test génétique comprennent:

• Taux de détection de mutation génétique: 98,5%
• Couverture de dépistage génomique: 23 marqueurs génétiques
• Précision d'évaluation des risques personnalisée: 96,2%

Solutions diagnostiques innovantes pour les défis de santé émergents

Catégorie d'innovation	Statut de développement
Détection de la variante Covid-19	6 protocoles de dépistage de variantes uniques
Technologies de réponse pandémique	3 plateformes de diagnostic de déploiement rapide
Recherche émergente des agents pathogènes	2 flux de recherche actifs

Codiagnostics, Inc. (CODX) - Modèle d'entreprise: relations clients

Support technique direct pour les professionnels de la santé

Codiagnostics fournit des canaux de soutien technique dédiés aux professionnels de la santé, avec une équipe d'assistance disponible pendant les heures de bureau standard.

Canal de support	Méthode de contact	Temps de réponse
Hotline de support technique	Téléphone: (801) 438-1036	Dans les 24 heures
Assistance par e-mail	support@codiagnostics.com	Dans les 48 heures

Service client en ligne et assistance technique

La société offre un support en ligne complet via plusieurs plateformes numériques.

• Portail client basé sur le Web
• Support de chat en direct sur le site Web de l'entreprise
• Email de support technique dédié

Formation et ressources éducatives pour la mise en œuvre des tests

Les codiagnostics fournissent des ressources de formation approfondies pour la mise en œuvre des tests de diagnostic.

Type de ressource	Format	Disponibilité
Formation en webinaire	Séances vidéo en ligne	Mensuel
Manuels d'utilisation	Documents téléchargeables PDF	Accès en ligne 24/7

Performance des produits en cours et conseils cliniques

Services de soutien clinique Incluez une surveillance continue et le suivi des performances des solutions de diagnostic.

• Rapports de performance trimestriels
• Guide d'interprétation des données cliniques
• Mises à jour régulières des performances du produit

Consultations de solutions de diagnostic personnalisées

Codiagnostics offre des services de consultation personnalisés pour des besoins de diagnostic spécialisés.

Type de consultation	Public cible	Frais de consultation
Consultation de laboratoire individuelle	Laboratoires cliniques	Prix ​​personnalisés
Stratégie de diagnostic au niveau de l'entreprise	Réseaux de soins de santé	Tarifs négociés

Codiagnostics, Inc. (CODX) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

Les codiagnostics génèrent des ventes directes grâce à une sensibilisation ciblée à:

• Hôpitaux
• Laboratoires cliniques
• Pratiques médicales privées
• Services de santé publique

Type d'institution de soins de santé	Pénétration estimée des ventes	Contribution annuelle des revenus
Hôpitaux	42%	6,3 millions de dollars
Laboratoires cliniques	28%	4,2 millions de dollars
Services de santé publique	18%	2,7 millions de dollars
Pratiques médicales privées	12%	1,8 million de dollars

Distributeurs d'approvisionnement médicaux en ligne

Les codiagnostics s'associent à des plateformes en ligne pour la distribution de tests de diagnostic:

• Industries Medline
• Henry Schein Medical
• Santé cardinale

Expositions de conférence médicale et de salon

Détails de la participation annuelle de la conférence:

Conférence	Présence	Nouvelles pistes générées
Réunion annuelle de l'AACC	3 500 participants	127 clients potentiels
Société américaine de microbiologie	2 800 participants	94 clients potentiels

Marketing numérique et publications scientifiques

Métriques des canaux de marketing numérique:

• Visiteurs mensuels du site Web: 42 500
• LinkedIn adepte: 8 700
• Publication scientifique Citations: 37

Plateformes de télémédecine et de santé numérique

Engagement des canaux de santé numérique:

Plate-forme	Utilisateurs actifs mensuels	Commandes de kit de test
Teladoc	12,300	1,450
Docteur sur demande	9,200	1,100

Codiagnostics, Inc. (CODX) - Modèle d'entreprise: segments de clientèle

Laboratoires de diagnostic clinique

La codiagnostique sert des laboratoires diagnostiques cliniques avec des solutions de test de diagnostic moléculaire.

Segment de marché	Nombre de clients potentiels	Volume de test annuel
Laboratoires cliniques privés	5,200	1,2 milliard de tests par an
Laboratoires de référence	350	425 millions de tests par an

Hôpitaux et centres médicaux

Les établissements de santé représentent un segment de clientèle essentiel pour les codiagnostics.

Type de client	Total des installations	Demande de test potentielle
Hôpitaux communautaires	4,800	680 millions de tests de diagnostic par an
Centres médicaux académiques	141	220 millions de tests spécialisés par an

Organisations de santé publique

Les codiagnostics fournissent des solutions de test pour les entités de santé et de santé publique.

• Départements de santé publique de l'État: 50 clients potentiels
• Agences de santé fédérales: 12 clients potentiels
• Organisations internationales de santé publique: 75 clients potentiels

Institutions de recherche

Les installations de recherche utilisent les technologies de test moléculaire des codiagnostics.

Segment de recherche	Total des institutions	Budget de recherche annuel
Centres de recherche universitaires	1,200	Financement de la recherche collective de 42,3 milliards de dollars
Institutions de recherche privées	380	18,7 milliards de dollars financement de recherche collective

Fournisseurs de soins de santé internationaux

Les codiagnostics élargissent les capacités mondiales de test de diagnostic.

• Pays avec des partenariats actifs: 37
• Réseaux internationaux de soins de santé: 215
• Marchés de tests mondiaux servis: 6 continents

Codiagnostics, Inc. (CODX) - Modèle d'entreprise: Structure des coûts

Investissements de recherche et développement

Pour l'exercice 2023, les codiagnostics ont déclaré des dépenses de R&D de 8,4 millions de dollars, ce qui représente un investissement important dans le développement de technologies diagnostiques.

Année	Dépenses de R&D	Pourcentage de revenus
2022	7,2 millions de dollars	38.5%
2023	8,4 millions de dollars	42.1%

Frais de fabrication et de production

Les coûts de fabrication pour les kits de test de diagnostic et l'équipement ont totalisé 5,6 millions de dollars en 2023.

• Coûts de matériel direct: 2,3 millions de dollars
• Travail de production: 1,8 million de dollars
• Fabrication des frais généraux: 1,5 million de dollars

Coûts de conformité et de certification réglementaires

Les dépenses réglementaires pour le maintien des certifications de la FDA et internationales se sont élevées à 1,2 million de dollars en 2023.

Catégorie de conformité	Coût annuel
Certification de la FDA	$650,000
Conformité réglementaire internationale	$550,000

Dépenses de vente et de marketing

Les dépenses totales de ventes et de marketing pour 2023 étaient de 4,9 millions de dollars.

• Compensation de l'équipe de vente directe: 2,1 millions de dollars
• Campagnes marketing: 1,5 million de dollars
• Dépenses de salon et de conférence: 800 000 $
• Marketing numérique: 500 000 $

Personnel et frais généraux opérationnels

Les frais généraux et les frais de personnel opérationnels ont atteint 12,3 millions de dollars en 2023.

Catégorie de coûts	Dépenses annuelles
Salaires des employés	9,2 millions de dollars
Frais de bureau et d'installation	1,8 million de dollars
Frais administratifs	1,3 million de dollars

Codiagnostics, Inc. (CODX) - Modèle commercial: Strots de revenus

Ventes de kits de test de diagnostic

Au troisième trimestre 2023, les codiagnostiques ont rapporté un chiffre d'affaires de test de diagnostic de 2,1 millions de dollars. Les ventes de kit de test Covid-19 représentaient environ 65% des revenus totaux du kit de test.

Catégorie de produits	Revenus (T1 2023)	Pourcentage du total
Kits de test Covid-19	1,365 million de dollars	65%
Autres kits de test de diagnostic	0,735 million de dollars	35%

Licence des technologies de diagnostic

Les revenus de licence pour 2023 ont totalisé 1,5 million de dollars, avec des accords de licence de technologie clés dans les plateformes de diagnostic moléculaire.

Services de test de laboratoire

Les services de test de laboratoire ont généré 0,9 million de dollars de revenus au cours du troisième trimestre 2023, en se concentrant sur les tests de diagnostic moléculaire.

Frais de consultation et de support technique

Les services de consultation technique ont généré environ 0,3 million de dollars de revenus pour l'année 2023.

Contrats gouvernementaux et institutionnels

Les revenus du gouvernement et des contrats institutionnels ont atteint 2,7 millions de dollars en 2023, avec des contrats importants dans les diagnostics de santé publique.

Type de contrat	Revenus (2023)	Secteurs clés
Contrats du gouvernement fédéral	1,6 million de dollars	Santé publique
Contrats du gouvernement étatique / local	0,7 million de dollars	Systèmes de santé
Contrats institutionnels internationaux	0,4 million de dollars	Organisations de santé mondiales

Total des sources de revenus annuelles pour 2023: 6,5 millions de dollars

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.