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- Cleveland Diagnostics
Cleveland Diagnostics Valuation, Funding & Investors
Cleveland Diagnostics is valued at $330M as of October 2025.
Last Cleveland Diagnostics valuation
$330M
Series A · Oct 2025
Last Cleveland Diagnostics funding round
$14M
Series A · Oct 2025
Cumulative funding Cleveland Diagnostics raised
$125M
across 8 funding rounds
Key investors in Cleveland Diagnostics
Novo Holdings
LYFE Capital
Cleveland Clinic
Genomic Health
About Cleveland Diagnostics
Cleveland Diagnostics is a Cleveland, Ohio-based diagnostics company founded in 2009. It employs solvent interaction analysis to develop protein biomarker tests for prostate, breast, and lung cancers. Lead product IsoPSA outperforms PSA screening with 94 percent sensitivity, while Aptly tests advance for breast cancer density assessment. The firm partners with Mayo Clinic for validation studies.
Founded
2013
HQ
Website
Status
Privately held
Customer focus
B2B
Revenue model
Services
Valuation
$330M (Oct 2025)
Cleveland Diagnostics Valuation
Cleveland Diagnostics is currently valued at $330M, based on its Series A in October 2025.
Cleveland Diagnostics valuation by funding round
| Date | Stage | Valuation |
|---|---|---|
| Oct 2025 | Series A | $330M |
Cleveland Diagnostics Funding History
Cleveland Diagnostics has raised a total of $125M across 8 funding rounds.
Cleveland Diagnostics' first fundraising round was a $2M seed round in March 2015. The most recent completed round was a $14M Series A in October 2025.
Cleveland Diagnostics funding rounds
| Date | Stage | Investors | Raised | Valuation | Deal Summary |
|---|---|---|---|---|---|
| Oct 2025 | Series A | - | $14M | $330M | Cleveland Diagnostics is a clinical-stage biotechnology company developing next-generation diagnostic tests for early cancer detection, with initial focus on prostate cancer. The company's flagship product is IsoPSA, a blood test that helps stratify prostate cancer risk and aids in biopsy decisions for men with elevated PSA levels. IsoPSA received FDA breakthrough designation in 2019, was launched as a laboratory developed test (LDT) in 2020, and secured FDA approval of its IsoPSA in vitro diagnostic (IVD) kit in December 2025, enabling distribution as a kit to clinical laboratories nationwide. In January 2024, Cleveland Diagnostics closed a $75 million growth capital financing round led by life sciences investment firm Novo Holdings, with participation from existing investors and a credit facility from Symbiotic Capital. The funds were designated to accelerate IsoPSA's commercial strategy, expand infrastructure and R&D pipeline development, and broaden geographic reach. By October 2025, the company achieved a Series E-2 valuation of $330.17 million. The company has established a national distribution agreement with Quest Diagnostics (2023) and expanded its pipeline beyond prostate cancer into additional oncology indications. In January 2026, Michael Iskra was appointed CEO to lead commercial scaling following FDA approval, with prior leadership transitioning to innovation-focused roles. |
| Jan 2024 | Undisclosed stage | Novo Holdings (lead) | $75M | - | Cleveland Diagnostics is a clinical-stage biotechnology company developing next-generation blood-based diagnostic tests for early cancer detection, focusing on protein structure changes rather than concentration. Its lead product, IsoPSA, stratifies prostate cancer risk to aid biopsy decisions and reduce overdiagnosis. The company announced the closing of over $75 million in growth capital financing on January 17, 2024, led by Novo Holdings with participation from existing investors and a credit facility from Symbiotic Capital. Proceeds from the financing support acceleration of IsoPSA's commercial strategy, expanded infrastructure, R&D pipeline development, and geographic expansion of the prostate cancer test. Cleveland Diagnostics plans to broaden its oncology portfolio beyond prostate cancer into indications like breast and lung cancer in 2024. Novo Holdings' investment aligns with its focus on life sciences growth opportunities to improve patient outcomes and clinician processes. The financing provides capital flexibility amid rising demand for IsoPSA. |
| Feb 2021 | Series D | LYFE Capital (lead); Cleveland Clinic | $17M | - | - |
| Feb 2021 | Seed | - | $2M | - | - |
| Nov 2017 | Seed | Genomic Health (lead) | $2M | - | - |
| Dec 2016 | Series B | - | $5M | - | - |
| Jan 2016 | Series C | - | $8M | - | - |
| Mar 2015 | Seed | - | $2M | - | - |
Who has invested in Cleveland Diagnostics?
4 investors have backed Cleveland Diagnostics across its funding rounds, including Novo Holdings, LYFE Capital, Cleveland Clinic and Genomic Health.
Lead investors include Novo Holdings, LYFE Capital and Genomic Health.
Cleveland Diagnostics Investors
| Investor | HQ | Rounds | Role | First check |
|---|---|---|---|---|
| 1 | Lead | Jan 2024 | ||
| 1 | Participant | Feb 2021 | ||
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Benchmark 350K+ Funding Rounds and Disclosed VC Valuation Multiples
Sign up to see data on 350K+ funding rounds and disclosed revenue and EBITDA valuation multiples, from seed, through growth stage, to pre-IPO.
Start Free TrialCleveland Diagnostics Competitors
Cleveland Diagnostics competitors include listed companies like Myriad Genetics and Pacific Biosciences, and private ones like Vanqua Bio, Koniku, CureGenetics and Character Biosciences.
| Company | HQ | Status | Revenue | EBITDA | Valuation | Revenue Multiple |
|---|---|---|---|---|---|---|
| Private | - | - | $333M | - | ||
| Private | - | - | $337M | - | ||
| Private | - | - | $311M | - | ||
| Private | - | - | $356M | - | ||
| Publicly listed | $825M | ($332M) | $396M | 0.6x | ||
| Publicly listed | $160M | ($153M) | $429M | 5.6x |
Cleveland Diagnostics Public Comps
Cleveland Diagnostics is still privately-owned, but its public comps include Tauns Laboratories, Abclon, Myriad Genetics, Prenetics Global, Atrys Health, Pacific Biosciences, ToolGen, Veraxa Biotech, Korro Bio and Cibus.
| Last FY | EV/Revenue | EV/EBITDA | ||||||
|---|---|---|---|---|---|---|---|---|
| Revenue | EBITDA | Last FY | LTM | 2027E | Last FY | LTM | 2027E | |
| $120M | $58M | 3.9x | 5.0x | 8.1x | 12.9x | |||
| $3M | ($12M) | 79.2x | - | (22.2x) | - | |||
| $825M | ($332M) | 0.6x | 0.6x | (1.5x) | (16.8x) | |||
| $92M | ($33M) | 3.2x | 1.6x | (9.0x) | (8.3x) | |||
| $162M | ($12M) | 2.3x | 2.1x | (30.2x) | 14.9x | |||
| $160M | ($153M) | 5.6x | 5.6x | (5.9x) | (6.9x) | |||
| $951K | ($26M) | 211.6x | - | (7.8x) | - | |||
| $29K | ($79M) | 7313.2x | - | (2.6x) | - | |||
This data is available for Pro users. Sign up to see all Cleveland Diagnostics competitors and their valuation data. Start Free Trial | ||||||||
Common questions about Cleveland Diagnostics
| When was Cleveland Diagnostics founded? | Cleveland Diagnostics was founded in 2013. |
| Where is Cleveland Diagnostics headquartered? | Cleveland Diagnostics is headquartered in Cleveland, OH, United States. |
| Is Cleveland Diagnostics publicly listed? | No, Cleveland Diagnostics is a private, VC-backed company. |
| What is Cleveland Diagnostics' valuation? | Cleveland Diagnostics was last valued at $330M in its Series A in October 2025. |
| How much funding has Cleveland Diagnostics raised? | Cleveland Diagnostics has raised $125M across 8 funding rounds. |
| What was Cleveland Diagnostics' last funding round? | Cleveland Diagnostics' last funding round was a $14M Series A in October 2025. |
| Who are Cleveland Diagnostics' investors? | Cleveland Diagnostics' investors include Novo Holdings, Cleveland Clinic, LYFE Capital and Genomic Health. |
| Which companies are comparable to Cleveland Diagnostics? | Companies comparable to Cleveland Diagnostics include Vanqua Bio, Koniku, CureGenetics, Character Biosciences, Myriad Genetics and Pacific Biosciences. |
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