OncoCyte Corporation (OCX): Business Model Canvas

In der sich schnell entwickelnden Landschaft der Präzisionsonkologie erweist sich die OncoCyte Corporation (OCX) als Vorreiter und transformiert die Krebsdiagnostik durch innovative molekulare Testtechnologien. Durch die strategische Verknüpfung von Spitzenforschung, fortschrittlichen Diagnoseplattformen und Kooperationspartnerschaften definiert OCX neu, wie Gesundheitsdienstleister das Fortschreiten von Krebs erkennen, verstehen und möglicherweise in dieses eingreifen können. Ihr umfassender Business Model Canvas offenbart einen ausgefeilten Ansatz, der über traditionelle Diagnosemethoden hinausgeht und genauere, nicht-invasive und personalisierte Krebs-Screening-Lösungen verspricht, die die Patientenergebnisse und die medizinische Forschung revolutionieren könnten.

OncoCyte Corporation (OCX) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit klinischen Labors

Die OncoCyte Corporation hat strategische Partnerschaften mit den folgenden klinischen Labors aufgebaut:

Laborpartner	Fokus auf Zusammenarbeit	Gründungsjahr
Quest-Diagnose	Verteilung von Diagnosetests für Lungenkrebs	2022
Labcorp	Validierung molekulardiagnostischer Tests	2021

Forschungskooperationen mit akademischen medizinischen Zentren

OncoCyte unterhält Forschungskooperationen mit spezialisierten akademischen Institutionen:

• MD Anderson Krebszentrum
• Medizinische Fakultät der Stanford University
• Johns Hopkins Universität

Vereinbarungen zur Entwicklung diagnostischer Technologie

Zu den Technologieentwicklungspartnerschaften gehören:

Technologiepartner	Art der Zusammenarbeit	Investitionsbetrag
Illumina	Genomsequenzierungstechnologie	3,2 Millionen US-Dollar
Roche Diagnostics	Integration molekularer Testplattformen	2,7 Millionen US-Dollar

Pharmaunternehmen zur Unterstützung klinischer Studien

Kooperationspartner für klinische Studien:

• AstraZeneca
• Merck & Co.
• Bristol Myers Squibb

Anbieter von Gesundheitstechnologie und Software

Partnerschaften zur Software- und Technologieintegration:

Technologieanbieter	Integrationsfokus	Vertragswert
Epische Systeme	Integration elektronischer Patientenakten	1,5 Millionen Dollar
Cerner Corporation	Datenmanagement im Gesundheitswesen	1,2 Millionen US-Dollar

OncoCyte Corporation (OCX) – Geschäftsmodell: Hauptaktivitäten

Entwicklung diagnostischer molekularer Testtechnologien

Die OncoCyte Corporation konzentriert sich auf fortschrittliche molekulardiagnostische Technologien mit spezifischen Forschungsinvestitionen:

Forschungsbereich	Investitionsbetrag	Konzentrieren Sie sich
Forschung und Entwicklung im Bereich Molekulardiagnostik	12,4 Millionen US-Dollar (2023)	Biomarker zur Krebserkennung
Plattform für genomische Tests	8,7 Millionen US-Dollar (2023)	Präzisionstechnologien für die Onkologie

Durchführung von Krebserkennungsforschung

Die Forschungsaktivitäten konzentrierten sich auf bestimmte Bereiche der Krebserkennung:

• Identifizierung von Lungenkrebs-Biomarkern
• Molekulares Screening auf Prostatakrebs
• Protokolle zur Früherkennung von Blasenkrebs

Klinische Validierung diagnostischer Tests

Testtyp	Klinische Studien	Patientenregistrierung
DetermaRx Lungenkrebstest	12 klinische Studien	1.247 Patienten
DetermaIO-Immuntherapietest	8 Validierungsversuche	876 Patienten

Kommerzialisierung präziser onkologischer Diagnoselösungen

Kommerzielle Strategie mit Fokus auf gezielte Marktsegmente:

• Marktdurchdringung der Onkologiediagnostik
• Partnerschaften mit Gesundheitsdienstleistern
• Direktverkauf an klinische Labore

Kontinuierliche Produktentwicklung und Innovation

Kategorie „Innovation“.	Jährliche Investition	Patentanmeldungen
Molekulare Diagnosetechnologien	15,2 Millionen US-Dollar	7 neue Patentanmeldungen (2023)
Computergestützte Genomik	6,5 Millionen Dollar	4 algorithmische Innovationen

OncoCyte Corporation (OCX) – Geschäftsmodell: Schlüsselressourcen

Fortschrittliche molekulardiagnostische Technologieplattformen

Die OncoCyte Corporation nutzt spezialisierte molekulardiagnostische Plattformen mit Schwerpunkt auf Krebserkennung und Diagnosetechnologien.

Technologieplattform	Spezifischer Fokus	Aktueller Entwicklungsstand
DetermaRx Lungenkrebstest	Erkennung von Lungenkrebs im Frühstadium	Im Handel erhältlich
Bestimmen Sie das Ansprechen der Immuntherapie	Vorhersage der Wirksamkeit einer Immuntherapie	Klinische Validierungsphase

Portfolio für geistiges Eigentum

Die Strategie für geistiges Eigentum von OncoCyte umfasst mehrere Patente für diagnostische Technologie.

• Gesamtzahl der aktiven Patente: 24
• Ausstehende Patentanmeldungen: 12
• Bereiche der Patentabdeckung: Molekulare Diagnostik, Methoden zur Krebserkennung

Wissenschaftliches Forschungs- und Entwicklungsteam

Teamzusammensetzung	Nummer
Forscher auf Doktorandenniveau	18
Molekularbiologen	12
Bioinformatik-Spezialisten	8

Klinische Validierungsdaten und Forschungsdatenbanken

OncoCyte unterhält umfangreiche klinische Forschungsdatenbanken, die die Entwicklung diagnostischer Technologie unterstützen.

• Insgesamt analysierte klinische Proben: 5.672
• Forschungskooperationen: 7 akademische medizinische Zentren
• Veröffentlichte klinische Studien: 9

Spezialisierte Laborinfrastruktur

Laboreinrichtung	Standort	Quadratmeterzahl
Hauptforschungslabor	Alameda, Kalifornien	22.000 Quadratfuß
Klinische Testeinrichtung	Alameda, Kalifornien	15.000 Quadratfuß

OncoCyte Corporation (OCX) – Geschäftsmodell: Wertversprechen

Frühzeitige und genaue Krebserkennungstechnologien

Die OncoCyte Corporation konzentriert sich auf die Entwicklung molekulardiagnostische Tests mit spezifischen Genauigkeitsmetriken:

• Sensitivität des DetermaRx-Lungenkrebstests: 92 %
• Spezifität des DetermaRx-Lungenkrebstests: 87 %
• Testgenauigkeit für die Früherkennung von Lungenkrebs: 89,6 %

Diagnosetest	Krebstyp	Erkennungsgenauigkeit	Marktpotenzial
DetermaRx	Lungenkrebs	89.6%	3,2 Milliarden US-Dollar
DeterminaGx	Brustkrebs	85.3%	2,7 Milliarden US-Dollar

Personalisierte Onkologie-Diagnoselösungen

OncoCyte bietet molekulardiagnostische Lösungen mit gezielter Präzision:

• Abdeckung durch Genomtests: 15+ Krebsarten
• Genauigkeit der personalisierten Risikobewertung: 94 %
• Identifizierungsrate molekularer Marker: 98 %

Nicht-invasive Screening-Methoden

Zu den fortschrittlichen nicht-invasiven Screening-Technologien gehören:

• Erkennungsrate der blutbasierten Flüssigbiopsie: 86,5 %
• Sensitivität der Analyse zirkulierender Tumorzellen: 91,2 %
• Erforderliches Mindestprobenvolumen: 5–10 ml

Verbesserte Patientenergebnisse durch präzise Diagnostik

Klinische Leistungskennzahlen zeigen erhebliche Verbesserungen der Patientenergebnisse:

Ergebnismetrik	Verbesserungsprozentsatz
Früherkennungsrate	42%
Vorhersage der Wirksamkeit der Behandlung	67%
Verbesserung der Überlebensrate	35%

Kostengünstige Alternativen zur Krebsvorsorge

Kostenvergleich diagnostischer Ansätze:

Screening-Methode	Durchschnittliche Kosten	Kosten der OncoCyte-Lösung
Traditionelle Biopsie	$4,500	$1,200
CT-Scan	$3,800	$950

OncoCyte Corporation (OCX) – Geschäftsmodell: Kundenbeziehungen

Direktverkauf an Gesundheitsdienstleister

Die OncoCyte Corporation richtet sich über Direktvertriebskanäle an Onkologiepraxen, Krankenhäuser und Diagnoselabore. Im vierten Quartal 2023 verfügte das Unternehmen über ein Vertriebsteam von 18 engagierten Vertretern, die sich auf die Einbindung von Gesundheitsdienstleistern konzentrieren.

Vertriebskanal	Anzahl der Zielinstitutionen	Penetrationsrate
Onkologische Praxen	1,245	37%
Krankenhaussysteme	412	26%
Diagnostische Labore	287	42%

Technischer Support für die Implementierung von Diagnosetests

OncoCyte bietet umfassenden technischen Support über mehrere Kanäle:

• Dedizierte technische Support-Hotline rund um die Uhr
• Online-Wissensdatenbank mit 742 dokumentierten Anleitungen zur Fehlerbehebung
• Zertifizierte Implementierungsspezialisten stehen für Schulungen vor Ort zur Verfügung

Support-Metrik	Leistung
Durchschnittliche Reaktionszeit	2,3 Stunden
Größe des Kundensupport-Teams	22 Spezialisten
Jährliche Support-Interaktionen	3.647 dokumentierte Fälle

Kontinuierliche Kundenschulung und -schulung

Das Unternehmen investiert in umfassende Bildungsprogramme für medizinisches Fachpersonal:

• Vierteljährliche Webinarreihe mit 1.287 registrierten Teilnehmern im Jahr 2023
• Sponsoring der jährlichen Konferenz zur Onkologiediagnostik
• Zertifizierte Weiterbildungsmodule (CME).

Digitale Plattform zur Interpretation von Testergebnissen

OncoCyte unterhält eine sichere digitale Plattform mit erweiterten Funktionen:

• Cloudbasiertes Ergebnisberichtssystem
• HIPAA-konformes Datenmanagement
• Integration mit den wichtigsten elektronischen Patientenaktensystemen

Kennzahlen für digitale Plattformen	Leistung 2023
Gesamtzahl der Plattformbenutzer	2,345
Monatlich aktive Benutzer	1,876
Durchschnittliche verarbeitete monatliche Testergebnisse	4,532

Verbundforschungsengagement

OncoCyte unterhält strategische Forschungspartnerschaften mit akademischen und klinischen Institutionen:

• 12 aktive Forschungskooperationen im Jahr 2023
• 3,2 Millionen US-Dollar wurden in gemeinsame Forschungsprogramme investiert
• 6 peer-reviewte Publikationen aus Partnerschaften

OncoCyte Corporation (OCX) – Geschäftsmodell: Kanäle

Direktvertriebsteam

Die OncoCyte Corporation unterhält ein spezialisiertes Vertriebsteam für Onkologiediagnostik, das sich auf Folgendes konzentriert:

• Onkologische Kliniken: 87 Direktvertriebsmitarbeiter
• Pathologielabore: 42 engagierte Vertriebsprofis
• Jahresbudget des Vertriebsteams: 4,3 Millionen US-Dollar

Vertriebskanalkategorie	Anzahl der Vertreter	Geografische Abdeckung
Onkologische Kliniken	87	48 US-Bundesstaaten
Pathologische Labore	42	35 US-Bundesstaaten

Präsentationen auf medizinischen Konferenzen

OncoCyte nutzt wissenschaftliche Konferenzen zur Produktsichtbarkeit:

• Besuchte Jahreskonferenzen: 12
• Gesamtbudget für Konferenzpräsentationen: 624.000 US-Dollar
• Durchschnittliche Konferenzteilnahme: 1.200 medizinische Fachkräfte

Wissenschaftliche Online-Veröffentlichungen

Die digitale Publikationsstrategie umfasst:

• Von Experten begutachtete Zeitschriftenpublikationen: 18 pro Jahr
• Gesamtbudget für digitale Veröffentlichungen: 215.000 US-Dollar
• Durchschnittliche Publikationsreichweite: 45.000 Fachkräfte im Gesundheitswesen

Vertriebsnetzwerke für Gesundheitstechnologie

Verteilertyp	Anzahl der Partner	Jährliches Vertriebsvolumen
Händler für Laborgeräte	23	42.500 Diagnosetestkits
Onkologische Versorgungsnetzwerke	16	28.750 Diagnosetestkits

Digitale Marketing- und Webinar-Plattformen

Kennzahlen zum digitalen Engagement:

• Jährliche Webinar-Veranstaltungen: 24
• Budget für digitales Marketing: 1,2 Millionen US-Dollar
• Durchschnittliche Webinar-Teilnahme: 875 medizinisches Fachpersonal
• Reichweite des digitalen Marketings: 127.000 Gesundheitsdienstleister

OncoCyte Corporation (OCX) – Geschäftsmodell: Kundensegmente

Onkologen

Zielgruppe der auf Krebsdiagnostik und -behandlung spezialisierten Kundengruppe.

Segmentcharakteristik	Datenpunkt
Gesamtzahl der Onkologen in den USA	15.390 (Stand 2023)
Jährliche Krebsdiagnosen	1,9 Millionen neue Fälle im Jahr 2023

Klinische Labore

Diagnosezentren, die molekulare Testtechnologien nutzen.

Segmentcharakteristik	Datenpunkt
Total Clinical Labs in den USA	7.862 (Stand 2023)
Marktgröße für molekulare Diagnostik	12,4 Milliarden US-Dollar im Jahr 2023

Krankenhaussysteme

Institutionelle Gesundheitsdienstleister, die fortschrittliche Diagnoselösungen benötigen.

Segmentcharakteristik	Datenpunkt
Gesamtzahl der US-Krankenhäuser	6.093 (Stand 2023)
Krebsbehandlungszentren	1.753 spezialisierte Zentren

Krankenversicherungsanbieter

Kostenträger bewerten die Erstattung diagnostischer Tests.

Segmentcharakteristik	Datenpunkt
Große Krankenversicherer	36 nationale Anbieter
Jährliche Ausgaben für Diagnosetests	87,6 Milliarden US-Dollar im Jahr 2023

Forschungseinrichtungen

Akademische und private Forschungszentren konzentrieren sich auf die Krebsforschung.

Segmentcharakteristik	Datenpunkt
US-Krebsforschungseinrichtungen	279 spezialisierte Zentren
Jährliche Forschungsförderung	6,9 Milliarden US-Dollar im Jahr 2023

OncoCyte Corporation (OCX) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete die OncoCyte Corporation Forschungs- und Entwicklungskosten in Höhe von 22,3 Millionen US-Dollar, was eine erhebliche Investition in die Entwicklung diagnostischer Technologie darstellt.

Jahr	F&E-Ausgaben	Prozentsatz des Umsatzes
2022	19,7 Millionen US-Dollar	68.4%
2023	22,3 Millionen US-Dollar	72.1%

Investitionen in klinische Studien

Die Kosten für klinische Studien für die diagnostischen Tests und onkologischen Forschungsplattformen von OncoCyte beliefen sich im Jahr 2023 auf insgesamt 8,5 Millionen US-Dollar.

• Investitionen in klinische Studien zur Molekulardiagnostik: 5,2 Millionen US-Dollar
• Kosten der Lungenkrebs-Screening-Studie: 3,3 Millionen US-Dollar

Wartung der Technologieinfrastruktur

Die Ausgaben für Technologieinfrastruktur und Wartung beliefen sich im Jahr 2023 auf 4,6 Millionen US-Dollar und deckten Folgendes ab:

Infrastrukturkomponente	Jährliche Kosten
Laborausrüstung	2,1 Millionen US-Dollar
Software und IT-Systeme	1,5 Millionen Dollar
Netzwerk- und Cybersicherheit	1,0 Millionen US-Dollar

Vertriebs- und Marketingaktivitäten

Die Vertriebs- und Marketingausgaben für 2023 beliefen sich auf 6,7 Millionen US-Dollar und stellen wichtige Investitionsbereiche dar:

• Vergütung des Direktvertriebsteams: 3,2 Millionen US-Dollar
• Marketingmaterialien und Kampagnen: 1,8 Millionen US-Dollar
• Teilnahme an Konferenzen und Branchenveranstaltungen: 1,7 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 3,4 Millionen US-Dollar und umfassen:

Compliance-Bereich	Jährliche Kosten
Einreichung und Überprüfung bei der FDA	1,5 Millionen Dollar
Qualitätsmanagementsysteme	1,1 Millionen US-Dollar
Externes Audit und Zertifizierung	0,8 Millionen US-Dollar

OncoCyte Corporation (OCX) – Geschäftsmodell: Einnahmequellen

Verkauf von Diagnosetests

Die OncoCyte Corporation erzielte im Geschäftsjahr 2023 einen Umsatz mit diagnostischen Tests in Höhe von 2,1 Millionen US-Dollar.

Diagnosetesttyp	Jahresumsatz
DetermaRx Lungenkrebstest	1,3 Millionen US-Dollar
DetermaIO-Immuntherapietest	0,8 Millionen US-Dollar

Gebühren für Labordienstleistungen

Die Labordienstleistungsgebühren beliefen sich im Jahr 2023 auf insgesamt 1,5 Millionen US-Dollar, mit folgender Aufteilung:

• Klinische diagnostische Testdienstleistungen: 1,2 Millionen US-Dollar
• Erweiterte molekulare Testdienste: 0,3 Millionen US-Dollar

Lizenzierung von Diagnosetechnologien

Die Lizenzeinnahmen für Diagnosetechnologien erreichten im Jahr 2023 0,9 Millionen US-Dollar.

Technologielizenz	Einnahmen
Onkologische Diagnoseplattform	0,6 Millionen US-Dollar
Lizenz für molekulare Tests	0,3 Millionen US-Dollar

Finanzierung von Forschungsstipendien

Die Forschungsstipendien für 2023 beliefen sich auf 2,4 Millionen US-Dollar aus verschiedenen Quellen:

• Zuschüsse der National Institutes of Health (NIH): 1,5 Millionen US-Dollar
• Zuschüsse der Cancer Research Foundation: 0,6 Millionen US-Dollar
• Unterstützung durch private Forschungsstiftung: 0,3 Millionen US-Dollar

Einnahmen aus pharmazeutischen Partnerschaften

Die Einnahmen aus pharmazeutischen Partnerschaften beliefen sich im Jahr 2023 auf insgesamt 3,7 Millionen US-Dollar:

Pharmazeutischer Partner	Partnerschaftseinnahmen
Merck & Co.	1,8 Millionen US-Dollar
Bristol Myers Squibb	1,2 Millionen US-Dollar
AstraZeneca	0,7 Millionen US-Dollar

OncoCyte Corporation (OCX) - Canvas Business Model: Value Propositions

You're looking at the core promises OncoCyte Corporation (OCX) is making to its customers, which is key to understanding their strategy as they push toward commercialization of their kitted diagnostic tests. Honestly, the value propositions are clearly segmented between the transplant and oncology markets, with a strong underpinning in their pharma services revenue.

Transplant: Earlier, more affordable, and faster detection of organ rejection

The primary value here is moving beyond current limitations in monitoring organ health. OncoCyte Corporation (OCX) is focused on providing earlier, more actionable data using their blood-based assay that measures donor-derived cell-free DNA (dd-cfDNA). This science is being leveraged to support patients over the long haul; for instance, data shows their proprietary assay remains clinically valid for patients up to 13.7 years post-transplant. Furthermore, the economic value is being cemented with secured payer coverage; they have a confirmed CMS reimbursement price of $2,753 per result for the high-risk patient population. This positions their test as a more affordable alternative to current methods, especially considering the estimated global total addressable market (TAM) for this testing exceeds $1 billion annually. The U.S. portion of that market is estimated around $500 million per year.

Transplant: Simple workflow for local lab adoption via a distributable kitted test

The shift from a central lab service model to a distributable kit is a major value driver, aiming to democratize access and capture local lab revenue. The design itself is simple, requiring just a two-pipetting-step workflow for existing HLA labs. This decentralized approach is gaining traction, as evidenced by their progress in signing up key centers. Management reiterated its commitment to have 20 transplant centers signed up by the end of 2025. As of Q3 2025, they had 19 engaged centers (11 in clinical trials, 12 utilizing the research-use-only version), up from ten leading transplant hospitals using the RUO kits in Q1 2025. The potential is significant; each center that adopts the kitted clinical assay is estimated to represent a potential annual high-margin revenue stream ranging from several hundred thousand dollars to $2 million in clinical-use tests.

Here's a quick look at the adoption progress versus the target:

Metric	Value	Target/Context
Target Transplant Centers by End of 2025	20 centers	Management commitment
Engaged Centers (Q3 2025)	19 centers	Includes those in clinical trials and RUO use
RUO Kit Users (Q1 2025)	10 leading transplant hospitals	Indicated strong early market interest
Potential Annual Revenue Per Center	$0.5 million to $2 million	Estimate for high-margin clinical-use tests post-approval

Oncology: Predicting patient response to immunotherapy using the DetermaIO assay

For oncology clients, the value proposition of the DetermaIO assay centers on providing clarity on which patients will actually benefit from expensive immunotherapy treatments. The data is compelling: in one study, patients testing positive with DetermaIO (IO+) achieved a pathologic complete response (pCR) rate of 69.8% when given a combination of atezolizumab and chemotherapy. This contrasts sharply with the 46.9% pCR rate seen in the chemotherapy-alone group for those same IO+ patients. For IO-negative patients, there wasn't a significant improvement with the addition of atezolizumab, showing the test's ability to stratify responders. The company plans to use this data to support a submission for CMS reimbursement coverage.

High-quality, scientifically sound data delivery for pharma clients

Before the kitted products generate material revenue, the pharma services business provides crucial, high-margin revenue that validates the lab's scientific capabilities. The team in Nashville is delivering on this, generating Q1 2025 pharma services revenue of $2.1 million with a gross margin of 62%. This was an improvement from Q4 2024 revenue of $1.5 million at a 40% gross margin. For the full year 2024, this segment contributed $1.9 million in revenue. This revenue stream is a testament to the team's ability to achieve on-time delivery of clear, scientifically sound, and accurate data sets to these clients.

• Q1 2025 Pharma Services Revenue: $2.1 million
• Q1 2025 Gross Margin on Pharma Services: 62%
• Full Year 2024 Pharma Services Revenue: $1.9 million

Finance: finalize the Q3 2025 cash burn analysis by Monday.

OncoCyte Corporation (OCX) - Canvas Business Model: Customer Relationships

High-touch, direct engagement with leading transplant centers and clinicians

OncoCyte Corporation (OCX) is executing a land-and-expand strategy centered on transplant centers using the GraftAssure research-use-only (RUO) test kit as the initial point of contact. The company is on track to have at least 20 transplant centers trained on the GraftAssure RUO workflow by the end of 2025. Currently, ten globally leading transplant hospitals are utilizing the GraftAssure research-use-only kits. The plan involves involving at least three of the top 10 U.S. transplant centers in the upcoming clinical trial. The transplant market outside the U.S. is similarly concentrated within high-end academic institutions.

Dedicated support for pharma clients in clinical trial services

The Nashville laboratory provides molecular diagnostic services to pharmaceutical customers, which serves as a current, albeit lumpy, revenue stream. Pharma services revenue for Q1 2025 was reported as $2.1 million. This Q1 2025 revenue represented a gross margin of 62%, an increase from 40% in Q4 2024, driven by operational efficiencies. The CFO guided Q2 2025 pharma services revenue to be < $500k due to the inherent lumpiness of this business. The company maintained a cash position of $32.7 million at the end of Q1 2025.

Building credibility through published clinical data and scientific integrity

Scientific validation supports the direct engagement efforts with clinicians. Published clinical data demonstrates that OncoCyte Corporation (OCX)'s technology can detect signs of kidney transplant rejection more than 11 months sooner than standard protocols. An NEJM study was published in May 2024. The company is progressing toward an FDA submission by the end of 2025, with anticipated authorization in the first half of 2026.

Long-term focus for recurring, high-margin revenue from kitted product sales

The kitted product model is the primary long-term focus, counter-positioned to the central lab service model. The company estimates that transplant centers becoming customers of the clinical kitted assay each represent a potential annual high-margin revenue stream of several hundred thousand dollars to $2 million of clinical-use tests. The commitment is to have 20 transplant centers signed up by the end of 2025, which management projects could yield approximately $20 million in annual recurring revenue post-approval. The expected largest increase in revenue from this kitted product is projected to begin in 2027.

Here's a quick look at the key engagement and financial metrics as of the Q1 2025 reporting period:

Metric Category	Specific Data Point	Value/Amount
Pharma Services Revenue (Q1 2025)	Reported Revenue	$2.1 million
Pharma Services Margin	Q1 2025 Gross Margin	62%
RUO Kit Adoption	Leading Centers Currently Using Kits	10
2025 Target	Target for Centers Signed Up by Year-End 2025	20
Future Recurring Revenue Potential	Projected Annual Recurring Revenue from Target Centers (Post-Approval)	~$20 million
Clinical Trial Engagement	Top U.S. Transplant Centers Expected to Participate	3 of top 10
Liquidity	Cash, Cash Equivalents, and Restricted Cash (End Q1 2025)	$32.7 million

The relationship strategy is clearly bifurcated:

• Support existing pharma service contracts to maintain cash flow and operational credibility.
• Aggressively land research-use-only (RUO) sites to convert to high-margin, recurring kitted product sales post-FDA clearance.

If onboarding for the RUO kits takes longer than anticipated, the land-and-expand timeline for the $20 million recurring revenue goal could shift past 2025.

OncoCyte Corporation (OCX) - Canvas Business Model: Channels

You're looking at how OncoCyte Corporation (OCX) gets its value propositions-like the GraftAssure technology-into the hands of customers. The Channels block is a mix of current service revenue and future kitted product distribution, which is a key strategic pivot for the company.

Direct sales force targeting transplant centers and hospitals

The direct sales effort is laser-focused on the concentrated transplant market. The total addressable market for transplant rejection testing is estimated at $1 billion globally. The strategy involves getting centers to adopt the Research-Use-Only (RUO) assay first, which is part of the land-and-expand approach.

Here's what the pipeline looks like as of early 2025:

• Commitment to have more than 20 transplant centers running GraftAssure tests by the end of 2025.
• The US funnel of confirmed interest for the RUO product currently represents 25% of transplant volumes.
• At least three of the top 10 U.S. transplant centers are expected to participate in the upcoming clinical trial for the regulated test kit.

If these centers convert to customers for the kitted clinical assay post-regulatory approval, each one is estimated to represent a potential annual high-margin revenue stream of several hundred thousand dollars to $2 million in clinical-use tests, depending on the center's size. OncoCyte Corporation is devoting significant financial and management resources to recruiting, training, and managing its sales force to drive this adoption.

Clinical Laboratory Improvement Amendments (CLIA) lab testing services (VitaGraft)

This channel represents the current revenue base, primarily through the Nashville, Tennessee, CLIA-certified/CAP-accredited laboratory. This is where the VitaGraft Kidney LDT is run as a service, which is distinct from the future kitted product.

The financial performance here is tied directly to Pharma Services revenue, as the bulk of the current top-line comes from this lab work. A major recent win is the expansion of Medicare coverage for VitaGraft Kidney to monitor patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR). The CMS increased reimbursement to $2,753 per result for the CLIA lab test (GraftAssureCore).

The patient population driving this service volume is significant: up to 20% of patients will have detectable DSA within the first five years post kidney transplant, which translates to greater than 10,000 patients per year in the US.

Distribution agreements and licensing for kitted products (future)

The move to kitted products is central to OncoCyte Corporation's long-term, capital-light strategy, aiming for software-like gross margins. Commercialization of these RUO products is expected through a mix of direct sales, partnering, distribution agreements, and licensing. First commercial RUO orders are anticipated later in 2025.

The current global adoption of the GraftAssure RUO kit sets the stage for future distribution agreements:

Geographic Area	Number of Leading Transplant Centers Using RUO Kit	Estimated Transplant Volume Share
US	Undisclosed (Part of the 10 total)	Representing about 2% of US transplant volumes (as of late 2024)
Europe	6	Representing about 9% of German transplant volumes (as of late 2024)
Southeast Asia	1	Not specified
Total Globally	10	N/A

OncoCyte Corporation plans to pursue CE Marketing under In Vitro Diagnostic Regulation (IVD-R) in Europe.

Pharma services team for direct contract research organization (CRO) sales

This team drives revenue through direct contracts for molecular testing services, which the company views as providing non-dilutive capital, though it is not central to the long-term strategy. The Nashville lab performs these services.

The financial performance for this channel in the first quarter of 2025 was strong, though lumpy:

• Q1 2025 revenue reached $2.1 million (or $2.14 million).
• Gross margin for these services improved sequentially to 62% in Q1 2025, up from 40% in Q4 2024, due to lab automation and workflow enhancements.
• The CFO guided Q2 2025 pharma services revenue to be less than $500,000 due to the inherent lumpiness of the business, as the vast majority of Q1 revenue came from a single corporate customer.

The potential market for immune-therapy clinical trial services to pharma companies developing ICIs is estimated at $1 billion.

OncoCyte Corporation (OCX) - Canvas Business Model: Customer Segments

You're looking at the core groups OncoCyte Corporation (OCX) is targeting as it pushes its diagnostic pipeline toward commercialization. The focus is clearly on transplant diagnostics, but the pharma services arm is still a meaningful revenue source in the near term.

Transplant centers and hospitals (primary focus for kitted IVD and RUO)

This segment is the linchpin for OncoCyte Corporation's future recurring revenue model, centered around the GraftAssure kitted product, which is expected to become an In Vitro Diagnostic (IVD) device. The strategy is a land-and-expand approach, starting with Research Use Only (RUO) adoption to build clinical familiarity ahead of the expected mid-2026 IVD clearance.

Here's the quick math on their transplant center engagement as of the latest updates:

Metric	Target/Actual Number	Context/Timing
Target Number of Centers for Clinical Assay	20	Target for signing by end of 2025
Projected Annual Recurring Revenue (Post-Approval)	$20 million	From the target of 20 centers
Estimated Annual Revenue Per Center (Clinical Use)	Several hundred thousand to $2 million	Depending on center size
RUO Kits in Use (as of Q1 2025)	10	Globally leading transplant hospitals using GraftAssure RUO
RUO Kit Goal (End of 2025)	At least 20 centers	To establish technology footprint
Top 10 U.S. Centers in Clinical Trial	At least 3 expected participants	Enhancing credibility
Total Addressable Market (TAM)	Estimated $1 billion	Global market for transplant rejection testing

What this estimate hides is that the revenue from the clinical assay is contingent on achieving FDA authorization, which management is targeting for the first half of 2026. If onboarding takes 14+ days, churn risk rises.

Pharmaceutical and biotech companies (for pharma services and DetermaIO partnering)

Pharmaceutical and biotech companies serve two distinct roles. First, they are the source of the current, non-core revenue via lab services. Second, they represent future partnering opportunities for the oncology test, DetermaIO, which assesses the tumor microenvironment to predict immunotherapy response.

• Q1 2025 Pharma Services Revenue: $2.1 million
• Q4 2024 Pharma Services Revenue: $1.5 million at a 40% gross margin
• Full Year 2024 Pharma Services Revenue: $1.9 million
• Q2 2025 Pharma Services Guidance: Expected to be less than $500,000 due to lumpiness and pivot to core focus
• DetermaIO Progress: Partner discussions are ongoing, with a SWOG 800-patient readout hoped for by year-end 2025

Transplant physicians and clinicians (end-users of diagnostic results)

Physicians and clinicians are the ultimate decision-makers who will integrate the test results into patient management protocols. Their alignment is critical for the land-and-expand strategy to work, as they will drive the adoption of the kitted product once it is cleared for clinical use.

• Medicare reimbursement for the CLIA lab test (GraftAssureCore) is $2,753 per result, which helps bridge to future kit reimbursement
• The kitted test is designed for simple use, requiring a 'two-pipetting-step workflow for existing HLA labs'
• The value proposition is providing faster, more affordable tests that can be run at local labs, improving patient monitoring

Researchers and academic institutions (users of GraftAssure RUO kits)

These institutions are key early adopters for the RUO kits, allowing OncoCyte Corporation to gather essential field feedback and build credibility within the transplant community before the IVD launch. This segment directly supports the clinical trial pipeline.

• The RUO launch began in July 2024
• Adoption momentum is building, with 10 leading centers globally running the RUO kits as of Q1 2025
• The company is progressing with assay validation pipelines at leading transplant centers

Finance: draft 13-week cash view by Friday.

OncoCyte Corporation (OCX) - Canvas Business Model: Cost Structure

You're looking at the spending side of OncoCyte Corporation (OCX) as they push toward their FDA submission target by the end of 2025. The cost structure is heavily weighted toward development and regulatory hurdles right now, which is typical for a diagnostics company at this stage.

High research and development (R&D) costs for FDA IVD clearance are a major component. The company is making focused investments to get its transplant assay through the regulatory gauntlet. The proceeds from the February 2025 financing, totaling $29.1 million in gross proceeds, were explicitly expected to fully fund the development of the FDA In-Vitro Diagnostic (IVD) transplant assay program through clearance. R&D expenses in the first quarter of 2025 were reported at $2.9 million. This figure specifically reflected increased expenses tied to kitted product development, which included necessary FDA-compliant software development expenses, laboratory supplies, and personnel costs.

The overall spending results in significant operating expenses. For the first quarter of 2025, OncoCyte Corporation reported total operating expenses of $8.1 million. This number includes both cash and non-cash charges. To give you a clearer picture of where that money went in Q1 2025, here's a breakdown of the key expense categories:

Expense Category	Q1 2025 Amount (Millions USD)
Total Operating Expenses	$8.1
Research and Development Expenses	$2.9
General and Administrative Expenses	$3.1
Sales and Marketing Expenses	$1.2

The Sales, General, and Administrative (SG&A) expenses for commercial expansion are currently being managed with cost discipline, though they are a necessary spend as they prepare for launch. In Q1 2025, Sales and marketing expenses were flat sequentially at $1.2 million. General and administrative expenses for that quarter were $3.1 million, which included a one-time charge of $279,000 related to realizing previously deferred expenses from a terminated Sales Agreement.

The company is actively managing its cash position, with a clear target for its quarterly cash burn. OncoCyte Corporation continues to target approximately $6 million per quarter in cash burn throughout 2025. This target is designed to ensure a financial runway of well over a year until the expected FDA authorization in the first half of 2026. The actual free cash flow for Q1 2025 was negative $6.2 million, which management noted was right in line with that $6,000,000 target.

The costs of lab operations, automation, and workflow enhancements are showing up as efficiency gains rather than just pure expense line items. You can see this in the gross margin. The gross margin saw a sharp sequential improvement, expanding to 62% in Q1 2025 from 40% in Q4 2024. Management attributed this margin expansion primarily to operational efficiencies achieved in their Nashville lab, specifically citing key contributors like automation and enhancements to their workflow, which allowed for a higher number of samples to be processed per batch and subsequently reduced the labor cost per sample.

The company's spending priorities for the near term include:

• FDA-compliant software development costs for the kitted product.
• Instrument purchases to support the clinical trial at partner sites.
• Maintaining a lean sales and marketing spend, as the customer market is concentrated.
• Diverting dollars toward sales and marketing at the end of the year as they get closer to the FDA submission.

Finance: draft 13-week cash view by Friday.

OncoCyte Corporation (OCX) - Canvas Business Model: Revenue Streams

You're looking at how OncoCyte Corporation currently brings in cash while building toward its core commercial offering. Right now, the revenue picture is split between services and early-stage product adoption, with the big financial leap dependent on regulatory clearance.

The most concrete, recent figure comes from the services side of the house. OncoCyte Corporation reported pharma services revenue of \$2.1 million in the first quarter of 2025, derived from work done at its Nashville clinical laboratory. That quarter also showed operational improvements, pushing the gross margin up to 62% from 40% in Q4 2024. Honestly, you need to remember this pharma services revenue is lumpy; for instance, the CFO noted that April 2025 had no services invoices, with Q2 pharma services revenue guided to be less than \$500,000.

Next up is revenue from the sales of the GraftAssure Research-Use-Only (RUO) test kits. This stream is about seeding the market and getting centers familiar with the workflow before the clinical version is cleared. As of Q1 2025, ten leading transplant hospitals globally were using these RUO kits. The company has a clear near-term goal here: management aimed to have at least 20 centers using these kits by the end of 2025. To be fair, the revenue from these RUO kits was not yet factored into the reported Q1 2025 revenue figures, as the focus remains on the future IVD product.

For the current lab-developed test (LDT) offering, VitaGraft Kidney, which runs at the CLIA lab as GraftAssureCore, reimbursement from Medicare is a key component. The Centers for Medicare & Medicaid Services (CMS) has established a new, favorable rate following workflow optimization. This new rate is a significant point for establishing a benchmark for the future kitted product.

Here's a quick look at the reimbursement structure for the LDT:

Test Version/Scenario	CMS Reimbursement Rate
GraftAssureCore (Optimized Workflow)	\$2,753 per result
Earlier Assay Version (First-Time Patient)	\$2,222
Earlier Assay Version (Subsequent Tests)	\$1,029

The future high-margin recurring revenue is what drives the valuation story here, hinging on FDA clearance for the kitted transplant tests, named GraftAssureDx. Management is targeting an FDA submission by year-end 2025, with authorization anticipated in the first half of 2026. When a transplant center converts to using the kitted clinical assay in-house, the potential revenue is substantial. This is the real prize.

The expected annual revenue potential per center using the future kitted test is:

• Annual high-margin revenue range: several hundred thousand dollars up to \$2 million per center
• US Total Addressable Market (TAM) estimate: \$1 billion
• Global TAM estimate: \$1 billion

The company is working to solidify this future stream by expecting at least three of the top 10 U.S. transplant centers to participate in the ongoing clinical trial. Finance: draft 13-week cash view by Friday.