Cleveland Diagnostics
Cleveland Diagnostics is a Cleveland, Ohio-based precision oncology company developing blood-based cancer diagnostics on its proprietary IsoClear protein-structure platform. Its lead product, IsoPSA, is an FDA-approved prostate cancer test that helps urologists avoid unnecessary biopsies in men with elevated PSA.
- Company typePrivate
- Founded2013
- HeadquartersCleveland, United States
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Cleveland Diagnostics does
Cleveland Diagnostics, Inc. is a Cleveland, Ohio-based precision oncology diagnostics company founded in November 2013 as a spinout of Cleveland Clinic Innovations. The company develops a novel class of simple, affordable blood tests for cancer detection and risk assessment built on its proprietary IsoClear platform, which measures structural differences in proteins to determine whether biomarkers originated in cancer cells rather than relying on protein concentration alone. Its lead commercial product, IsoPSA, is a blood-based prostate cancer diagnostic that aids biopsy decision-making for men over 50 with elevated PSA levels and has been clinically validated to reduce unnecessary prostate biopsies by up to 55% with specificity 2-3x that of traditional PSA tests.
The company operates a dual-distribution model. It runs a CLIA-certified, CAP-accredited, SOC 2 Type II audited laboratory in Cleveland, Ohio, offering the IsoPSA test as both a laboratory-developed test (LDT) since July 2020 and an FDA-approved IVD assay since December 2025. It also distributes through enterprise partnerships, most notably a channel agreement with Quest Diagnostics (announced February 2023) for nationwide patient access and a digital-pathology workflow integration with Lumea (announced December 2025). Reimbursement is enabled by Medicare Local Coverage Determination and an assigned CPT-PLA code (October 2022), with NCCN Guideline inclusion (2022) supporting standard-of-care adoption.
Cleveland Diagnostics has raised approximately $112 million across multiple financing rounds (most recently $75M in January 2024 led by Novo Holdings and a $14.42M SEC Form D filing in October 2025), with Novo Holdings, Lyfe Capital, and Cleveland Clinic Innovations represented on the board. The company holds ISO 13485:2016 certification (May 2026), FDA Breakthrough Device Designation (2019), and operates state licenses in California, Maryland, Pennsylvania, Rhode Island, and New York. Its leadership bench was substantially refreshed in 2024-2026 with the appointments of CEO Michael Iskra, Chairman Jack Kenny, and new board directors Dara Grantham Wright and Rich Ramko, all signaling a transition from clinical-validation-stage to commercial-scale-stage operations.
Cleveland Diagnostics firmographics
Firmographics- Name
- Cleveland Diagnostics
- Legal name
- Cleveland Diagnostics, Inc.
- Website
- https://clevelanddx.com
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Cleveland Diagnostics is a Cleveland, Ohio-based precision oncology company developing blood-based cancer diagnostics on its proprietary IsoClear protein-structure platform. Its lead product, IsoPSA, is an FDA-approved prostate cancer test that helps urologists avoid unnecessary biopsies in men with elevated PSA.
- Ownership category
- akta.pro rank
Cleveland Diagnostics industry classification
Industry- Product category
- Cancer Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)
- akta.pro secondary industries
- Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays (HLAAALAN), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
Keywords
Where Cleveland Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Cleveland
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Cleveland Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain, Infrastructure
Revenue model
- Laboratory Testing Services: Revenue from providing IsoPSA testing services through CLIA-certified laboratories. The test is offered as both a laboratory developed test (LDT) and FDA-approved IVD assay following December 2025 FDA approval.
- Diagnostic Assay Commercialization: Revenue from commercialization of FDA-approved IsoPSA IVD Assay for use in clinical settings, with Medicare coverage determination and CPT-PLA code assignment supporting reimbursement.
- Partnership Licensing: Strategic partnerships with Quest Diagnostics and other healthcare providers expand access to testing, generating revenue through service agreements and expanded market reach.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Medicare Reimbursement |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels5 records
Cleveland Diagnostics product offering
Product offeringCore offering
Cleveland Diagnostics develops and commercializes blood-based cancer diagnostic tests built on its proprietary IsoClear platform, which measures structural differences in proteins to determine whether biomarkers originated in cancer cells. Its flagship commercial product, IsoPSA, is a blood-based prostate cancer test offered as both a CLIA-certified laboratory developed test (LDT) and an FDA-approved IVD assay (December 2025) for biopsy decision-making in men over 50 with elevated PSA levels.
Product overview
Cleveland Diagnostics offers a novel class of simple blood tests for cancer detection and risk assessment, built on its proprietary IsoClear platform. The company's first commercial product is IsoPSA, a blood-based prostate cancer test that reduces unnecessary biopsies by measuring structural changes in protein biomarkers. The IsoClear platform serves as the foundational technology enabling the IsoPSA test and supporting expansion into additional cancer indications including thyroid, lung, and multi-cancer diagnostics. The company operates as a commercial-stage precision oncology company with both laboratory-developed test (LDT) and FDA-approved IVD versions of IsoPSA.
Differentiator
Problem solved
Functional benefit
Brands
- IsoPSA: Blood-based prostate cancer test that reduces unnecessary biopsies by up to 55%, with sensitivity and specificity 2-3 times that of traditional PSA tests.
- IsoClear
Products and services
- IsoPSA (Laboratory Developed Test) Blood-based prostate cancer test measuring structural differences in protein biomarkers to distinguish aggressive cancer from benign conditions, reducing unnecessary prostate biopsies by up to 55%. Performed in CLIA-certified high-complexity laboratories; intended for men over 50 with elevated PSA levels.
- IsoPSA IVD Assay FDA-approved (December 2025) in vitro diagnostic version of IsoPSA that aids in decision-making for prostate biopsies in men over 50 with elevated PSA levels; supports Medicare reimbursement via an assigned CPT-PLA code and inclusion in NCCN Guidelines for Prostate Cancer Early Detection.
Quantifiable outcome
- Reduces unnecessary prostate biopsies by up to 55%
- +1 more outcomes
Companies that use Cleveland Diagnostics
Customer profileNamed customers3 records
Segments3 records
Ideal customer profiles3 records
Cleveland Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Cleveland Diagnostics partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and minor.
- LumeacoreCollaboration to integrate IsoPSA prostate cancer blood test into Lumea's digital pathology platform, simplifying access for urologists and enhancing prostate cancer risk assessment. The integration aims to improve clinical workflows and diagnostic accuracy.
- Quest DiagnosticscoreStrategic agreement to expand patient access to IsoPSA prostate cancer testing through Quest Diagnostics' extensive laboratory network, enabling broader geographic reach and increased testing availability for patients and physicians.
- Genomic HealthminorStrategic collaboration announced in November 2017 to develop and commercialize new prostate cancer tests, combining Genomic Health's genomic testing expertise with Cleveland Diagnostics' IsoPSA technology platform.
Scale indicators5 records
Recent moves8 records
Expansion highlights6 records
Cleveland Diagnostics competitors and assessment
Company assessmentDirect peers
- OPKO Health: OPKO Health markets the 4Kscore test, a blood-based prostate cancer diagnostic that helps determine the need for biopsy. It directly competes with IsoPSA in the same clinical use case (pre-biopsy risk stratification for men with elevated PSA) and serves the same urology customer base.
- MDxHealth: MDxHealth commercializes SelectMDx, a urine-based molecular test for prostate cancer risk assessment prior to biopsy. It is a direct competitor in the prostate cancer diagnostics space, serving the same urologist decision-maker and addressing the same biopsy-avoidance value proposition.
Broad incumbents
- Beckman Coulter (Danaher): Beckman Coulter offers the Prostate Health Index (PHI), an established blood-based prostate cancer diagnostic with broad installed-base reimbursement. As a large diagnostics incumbent within Danaher, it competes head-to-head with IsoPSA in the same clinical workflow.
- Exact Sciences: Exact Sciences is a commercial-stage cancer diagnostics company (Cologuard, Oncotype DX) with a large sales force and proven urology/oncology channel relationships. It is comparable as a scaled cancer diagnostics commercializer pursuing similar customer segments.
- Guardant Health: Guardant Health is a leading liquid biopsy / oncology diagnostics company with FDA-approved tests and large-scale commercial operations. It is comparable as a precision oncology diagnostics peer pursuing blood-based cancer detection and monitoring.
- NeoGenomics: NeoGenomics is a specialty oncology testing laboratory offering a broad menu of cancer diagnostics. It is comparable as a clinical laboratory operator serving oncologists and urologists with proprietary and third-party cancer tests.
- Bio-Techne: Bio-Techne is a life sciences tools and diagnostics company with proprietary protein-based assay technologies. It is comparable as a diagnostics player leveraging protein biomarker science, with overlapping R&D capabilities in protein analytics.
- Hologic: Hologic is a large diagnostics and medical device company with established women's health and emerging oncology diagnostics portfolios. It is comparable as a scaled diagnostics commercializer with regulatory, manufacturing, and sales infrastructure relevant to commercial-stage oncology diagnostics.
Emerging players
- Veracyte: Veracyte is a genomic diagnostics company with urology and oncology franchises (including the Decipher Prostate genomic classifier). It is comparable as a cancer diagnostics peer with overlapping urology customer targets and a portfolio expansion strategy.
- GRAIL: GRAIL developed the Galleri multi-cancer early-detection blood test, pursuing a blood-based oncology diagnostics model at larger scale. It is comparable as a blood-based cancer detection peer, although operating in a broader (multi-cancer) indication space than IsoPSA.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Cleveland Diagnostics social profiles
Digital presenceCleveland Diagnostics compliance and trust
Trust signalCompliance4 records
Cleveland Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cleveland Diagnostics leadership team
Management profileNumber of profiles
Profiles12 records
Cleveland Diagnostics funding detail
Funding detailFunding overview
Funding rounds9 records
Investors5 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cleveland Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Cleveland Diagnostics
What does Cleveland Diagnostics do?
Cleveland Diagnostics develops and commercializes blood-based cancer diagnostic tests built on its proprietary IsoClear platform, which measures structural differences in proteins to determine whether biomarkers originated in cancer cells. Its flagship commercial product, IsoPSA, is a blood-based prostate cancer test offered as both a CLIA-certified laboratory developed test (LDT) and an FDA-approved IVD assay (December 2025) for biopsy decision-making in men over 50 with elevated PSA levels.
Is Cleveland Diagnostics a public or private company?
Cleveland Diagnostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Cleveland Diagnostics founded?
Cleveland Diagnostics was founded in 2013. It employs 51 to 100 people.
Where is Cleveland Diagnostics based?
Cleveland Diagnostics is headquartered in Cleveland, United States, in the North America region.
How does Cleveland Diagnostics make money?
Three revenue lines are on record. Laboratory Testing Services are the primary driver. The others are diagnostic Assay Commercialization and partnership Licensing.
Who are Cleveland Diagnostics's main competitors?
Direct peers on record are OPKO Health and MDxHealth. Broad incumbents are Beckman Coulter (Danaher), Exact Sciences, Guardant Health, NeoGenomics, Bio-Techne and Hologic. Emerging players are Veracyte and GRAIL.
Does Cleveland Diagnostics have an API?
No public API is recorded for Cleveland Diagnostics.
What industry is Cleveland Diagnostics in?
Cleveland Diagnostics's product category is Cancer Diagnostics. Its primary akta.pro industry code is HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy), with a secondary code of HLAAALAN, Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays. Its NAICS code is 325413 and its SIC code is 2835.