CirculoGene Theranostics

What CirculoGene Theranostics does

Circulogene Theranostics, Inc. is a privately held molecular diagnostics company founded in 2015 by Mike Mullen and headquartered in Birmingham, Alabama. The company operates CLIA-certified and CAP-accredited clinical laboratories in Birmingham, Pensacola (Florida), and West Palm Beach (Florida), and serves U.S. oncologists, hematologists, and cancer treatment centers with comprehensive genomic profiling (CGP) for solid tumors. Circulogene's core commercial offering combines next-generation sequencing (NGS) and polymerase chain reaction (PCR) on circulating cell-free DNA (cfDNA) and cell-free RNA (cfRNA) extracted from a single blood draw, using its proprietary LISA (Liquid Intelligent Solid Analysis) cfNA preparation method protected by U.S. Patent No. 11,015,213. The portfolio includes OncoGenLDx (486 DNA + 72 RNA biomarkers from plasma), the only commercially available plasma cfRNA PD-L1 test, the tissue-based OncoGenDx CGP assay (335 DNA + 72 RNA genes, launched nationally in October 2025 on the Roche AVENIO NGS platform with FoundationOne bioinformatics), and LungLifeAI, an AI-driven blood test for indeterminate pulmonary nodule risk stratification launched exclusively in June 2025.

The company generates revenue by billing clinical laboratory testing services to insurance (including Medicare) and self-pay patients, supported by the CIRCULOGENE Access Program for financial assistance. Its go-to-market is enterprise field sales targeting oncologists and cancer centers, supplemented by an online provider portal (portal.labtests.io), physician education programs, and participation in oncology conferences (AACR, ASCO, ASTRO). Per the company, over 25,000 cancer patients have been tested with its liquid biopsy genomic profiling to date. The company is led by CEO Mike Mullen (formerly President/CEO of Atherotech Diagnostics, which he scaled above $120M in revenue prior to its private-equity sale) and is governed by a board with senior diagnostics-industry veterans including former NeoGenomics President/CSO Bob Gasparini and former Guardant Health Global CMO Dr. Richard Lanman. Circulogene has raised approximately $24.3 million across disclosed funding rounds from 2015 through 2023, holds SAM.gov verified-vendor status for federal engagement, and remains a privately held Delaware corporation.

Name

CirculoGene Theranostics

Legal name

Circulogene Theranostics, Inc.

Website

https://circulogene.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

51–100 employees

Short description

Circulogene Theranostics is a CLIA-certified, CAP-accredited molecular diagnostics company that provides liquid-biopsy and tissue-based comprehensive genomic profiling — including cfDNA/cfRNA NGS panels, plasma PD-L1, and an AI-driven lung nodule test — to U.S. oncologists and cancer treatment centers.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics / Precision Oncology Laboratory Services

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG)

akta.pro secondary industries

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Molecular Tumor Boards & Clinical Interpretation Services (HLAAANAD)

Keywords

• Liquid biopsy testing
• Molecular diagnostics services
• Comprehensive genomic profiling
• Circulating tumor DNA analysis
• Precision oncology diagnostics

Headquarters

HQ city

Birmingham

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Laboratory Testing Services: Circulogene generates revenue through clinical laboratory testing services for cancer genomic profiling. Tests are billed to insurance (including Medicare) and self-pay patients. The company offers the CIRCULOGENE Access Program (CAP) for financial assistance to eligible patients.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Circulogene Theranostics is a clinical laboratory services company that delivers precision oncology diagnostics, including comprehensive genomic profiling of solid tumors from both liquid biopsy (blood) and tissue specimens. Its portfolio includes OncoGenLDx (large-panel cfDNA/cfRNA liquid biopsy NGS), OncoGenDx (tissue-based comprehensive genomic profiling on Roche AVENIO NGS), Plasma cfRNA PD-L1 testing, and LungLifeAI (AI-driven blood test for indeterminate pulmonary nodule risk stratification), all built on its proprietary LISA cfNA enrichment technology.

Product overview

Circulogene offers a portfolio of four distinct molecular diagnostic products for precision oncology: OncoGenLDx (liquid biopsy NGS panel with 486 DNA and 72 RNA biomarkers), Plasma cfRNA PD-L1 (the only liquid biopsy PD-L1 test), OncoGenDx (tissue-based CGP for solid tumors), and LungLifeAI (AI-driven blood test for indeterminate pulmonary nodule assessment). The portfolio combines liquid and tissue biopsy approaches, using both NGS and PCR technologies, with a single-tube blood draw providing cfDNA, cfRNA, MSI, PD-L1, and TMB results within approximately one week. OncoGenLDx and Plasma cfRNA PD-L1 complement tissue biopsy as recommended by IASLC; OncoGenDx extends the portfolio to tissue-based CGP; and LungLifeAI enables earlier lung cancer risk assessment independent of tissue sampling.

Differentiator

Problem solved

Functional benefit

Products and services

• OncoGenLDx A large-panel liquid biopsy next-generation sequencing (NGS) molecular assay that analyzes 486 DNA biomarkers and 72 RNA biomarkers from plasma cfDNA and cfRNA, detecting somatic mutations, RNA fusions, MSI, PD-L1 expression, and TMB for targeted therapy selection and cancer monitoring. It is intended for oncologists and cancer treatment centers managing solid tumor patients who need comprehensive molecular profiling from a single blood draw.
• Plasma cfRNA PD-L1 The only commercially available liquid biopsy cfRNA PD-L1 test, using real-time exosome-free PCR with PD-L1 specific primers to detect plasma PD-L1 expression for predicting immunotherapy response in cancer patients, particularly in advanced NSCLC. It is offered to oncologists as a stand-alone PD-L1 expression assessment from a blood draw.
• OncoGenDx A tissue-based comprehensive genomic profiling (CGP) assay built on Roche's AVENIO NGS platform and FoundationOne bioinformatics pipeline, interrogating 335 DNA genes and 72 RNA genes from FFPE tumor tissue across all solid tumors and reporting TMB, MSI, HRD, and PD-L1 IHC (22C3 clone with CPS scoring) in a unified report. It is intended for oncologists needing comprehensive tissue-based molecular profiling for precision oncology treatment decisions.
• LungLifeAI A non-invasive, AI-driven blood test that uses a proprietary 4-color fluorescence in situ hybridization (FISH) assay combined with machine learning image analysis to detect Circulating Genetically Abnormal Cells (CGACs) for risk stratification of indeterminate pulmonary nodules. It is intended to improve early lung cancer detection and reduce unnecessary invasive biopsies, and is positioned for pulmonologists, oncologists, and lung cancer screening programs.

Quantifiable outcome

• Comprehensive genomic profiling from a single blood draw (vs. invasive tissue biopsy)
• +2 more outcomes

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability7 records

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• Roche Diagnostics (AVENIO NGS Platform)coreTechnology or IntegrationCirculogene utilizes Roche's AVENIO NGS (Next-Generation Sequencing) platform for comprehensive genomic profiling. This technology partnership provides the sequencing infrastructure for the company's liquid biopsy tests including OncoGenDx and OncoGenLDx panels.
• FoundationOne (Bioinformatics Pipeline)coreTechnology or IntegrationCirculogene integrates FoundationOne's bioinformatics pipeline for data analysis and interpretation of genomic test results. This partnership enables validated bioinformatics workflows for cancer genomic profiling.

Scale indicators3 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Personalis: Genomics company offering tumor profiling (NeXT Personal) and MRD detection using whole-genome and exome NGS approaches. Comparable in NGS-based liquid biopsy and oncology CGP, with similar target customer (oncologists) and reimbursement-driven economics.
• Natera: Competitor in oncology liquid biopsy and molecular residual disease (MRD) testing (Signatera), as well as broader cell-free DNA applications. Comparable in cfDNA workflow, oncologist customer segment, and reimbursement/payer-driven business model.
• Veracyte: Genomic diagnostics company with a growing oncology franchise (Decipher Prostate, Afirma thyroid, Percepta lung). Comparable in molecular diagnostics for cancer treatment decisions and urologic/thoracic oncology customer overlap — and Circulogene board member Dr. Richard Lanman previously served as Veracyte CMO.
• Foundation Medicine: Direct tissue-based and liquid CGP competitor (FoundationOne CDx, FoundationOne Liquid CDx). Comparable in assay architecture and oncology customer base; Circulogene's OncoGenDx explicitly uses FoundationOne bioinformatics, making Foundation Medicine simultaneously a partner dependency and direct competitor.
• Guardant Health: Direct liquid biopsy competitor offering Guardant360 CDx for comprehensive genomic profiling in advanced cancer. Highly comparable in product category, target customers (oncologists), and NGS-based cfDNA workflow — and notably, Circulogene board member Dr. Richard Lanman was Guardant's former Global CMO.
• Tempus: AI-enabled precision medicine company offering NGS-based tumor profiling (xT), liquid biopsy (xF), and immunomics to oncologists. Comparable across multimodal molecular profiling, oncology customer base, and integration of AI/computational pipelines into diagnostic workflows.
• NeoGenomics: Specialized oncology testing services company offering solid tumor CGP, liquid biopsy, and hematology testing. Highly comparable in customer base (oncologists, hospitals) and CLIA/CAP lab services model — and Circulogene board member Bob Gasparini was NeoGenomics' former President and Chief Science Officer.
• Caris Life Sciences: Molecular profiling company offering tissue CGP (MI Profile) and liquid biopsy (MI Cancer Seek) with AI-driven interpretation. Directly comparable across comprehensive genomic profiling, immunotherapy biomarker reporting (MSI, TMB, PD-L1), and oncologist customer base.

Broad incumbents

• Exact Sciences: Larger diagnostics incumbent (Cologuard, Oncotype DX, Precision Oncology) with growing presence in liquid biopsy and multi-cancer detection. Comparable in cancer diagnostics and payor/clinical evidence-driven model, but operates at materially greater scale and broader indication coverage.

Emerging players

• Burning Rock Biotech: NGS-based cancer genomics company offering tumor profiling and liquid biopsy assays (e.g., OncoCompass) primarily in China with U.S. footprint. Comparable in NGS-based comprehensive genomic profiling technology and oncology customer focus, though predominantly serving a different geographic market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/_circulogene
• YouTubeyoutube.com/@circulogene7322/videos
• Facebookfacebook.com/circulogene
• LinkedInlinkedin.com/company/circulogene-diagnostics

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds7 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CirculoGene Theranostics