What IncellDx does

IncellDx, Inc. is a privately held, Delaware-incorporated molecular diagnostics company founded in 2009 and headquartered in Hayward, California, with a secondary office in Traverse City, Michigan. The company develops single-cell diagnostic products based on a proprietary platform that combines multiplex RNA in situ hybridization, multiplex protein detection, and DNA/cell cycle analysis to enable simultaneous classification and biomarker profiling at the individual cell level. The catalog spans HPV E6/E7 mRNA probes and the CE-IVD HPV OncoTect 3Dx cervical cancer screening kit, CMV mRNA probes, the incellPREP tissue single-cell suspension system (IVD/CE-IVD), the BioINK PD-L1 CTC circulating tumor cell research kit, and a line of general laboratory reagents and antibodies (incellMAX, CytoStat triCHROME, anti-PD-L1, anti-CD45, anti-pan cytokeratin) distributed across RUO, GPR, ASR, CE-IVD, and US-IVD regulatory designations.

The company sells primarily on a B2B basis to clinical laboratories, physicians, and research institutions via direct sales and the HealthBio e-commerce platform, with electronic instruction-for-use delivery through a key-code system at eifu.incelldx.com. ISO 13485:2016 certification (SGS) underpins manufacturing quality, and disclosed funding to date totals approximately $9.5 million across 2010 and 2012 rounds plus an in-progress $13.5 million exempt offering filed in July 2024. Leadership comprises CEO Bruce Patterson, founder and VP of Marketing Carol Penfold-Patterson, Chief Business Officer Chris Meda, and Chief Operating Officer Todd Pollard. The company is too small to have disclosed revenue, named anchor customers, or M&A activity, and AI/ML capabilities are not part of its stated technology stack.

Name

IncellDx

Legal name

IncellDx, Inc.

Website

https://incelldx.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

IncellDx is a private molecular diagnostics company developing single-cell IVD and research-use products—including the CE-IVD HPV OncoTect 3Dx kit and the incellPREP sample-prep system—sold B2B to clinical laboratories, physicians, and research institutions.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Surgical and Medical Instrument Manufacturing (339112)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Companion Diagnostics (CDx) & Precision Medicine IVD (HLAHAAAJ)

Keywords

• Single cell diagnostics
• Molecular diagnostics reagents
• In vitro diagnostics
• HPV E6 E7 mRNA
• Circulating tumor cell analysis

Headquarters

HQ city

Menlo Park

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Products and Reagents: Sale of IVD/CE-IVD diagnostic products including HPV OncoTect 3Dx, incellPREP sample preparation systems, and various reagents. Products are sold to medical laboratories and healthcare providers with regulatory clearances (CE-IVD, US-IVD) for clinical use.
2. Research Use Only (RUO) Products: Sale of research reagents including HPV Control Cells, CMV mRNA Probe, and BioINK products for laboratory research applications.
3. General Purpose Reagents (GPR) and ASR Products: Sale of hybridization core reagents, cell cycle dyes, fixatives, and antibodies to clinical and research laboratories.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

IncellDx manufactures and sells single cell diagnostic products and reagents, including IVD/CE-IVD kits (HPV OncoTect 3Dx, incellPREP tissue single cell suspension system), probes (HPV E6/E7 mRNA, CMV mRNA), general laboratory reagents (incellMAX fixatives, Hybridization Core Reagents, Cell Cycle Dye, CytoStat triCHROME), and antibodies (Anti PD-L1, Anti CD45, Anti Pan Cytokeratin). Products serve clinical laboratories, research institutions, and physicians with regulatory designations spanning RUO, GPR, ASR, CE-IVD, and US-IVD, enabling precision medicine diagnostics in oncology (HPV, CTCs) and infectious disease (CMV).

Product overview

IncellDx is a single cell diagnostic company offering a comprehensive portfolio of diagnostic products and reagents based on its proprietary multiplex RNA in situ hybridization and multiplex protein detection technology platform. The product portfolio includes: (1) Probes and assays including HPV E6, E7 mRNA Probe, CMV mRNA Probe, and HPV OncoTect 3Dx for cervical cancer diagnostics; (2) Laboratory reagents including Hybridization Core Reagents, incellMAX fixatives, Cell Cycle Dye, and CytoStat triCHROME for cell analysis; (3) Antibodies including Anti PD-L1, Anti CD45, and Anti Pan Cytokeratin; (4) The incellPREP sample preparation system comprising homogenizers, sample racks, and battery packs for tissue processing; and (5) BioINK PD-L1 CTC Core Kit for circulating tumor cell research. Products carry various regulatory designations including RUO (Research Use Only), GPR (General Purpose Reagent), ASR (Analyte Specific Reagent), IVD/CE-IVD, and US-IVD. The company positions itself in the precision medicine space enabling simultaneous cell classification and single cell analysis of proteomic and genomic biomarkers.

Differentiator

Problem solved

Functional benefit

Brands

• incellPREP: Sample preparation system for tissue single cell suspension, including homogenizers, sample racks, and battery packs
• incellMAX
• BioINK
• HPV OncoTect 3Dx
• CytoStat triCHROME

Products and services

• HPV OncoTect 3Dx CE-IVD certified kit for HPV E6, E7 mRNA detection using the OncoTect platform, used for cervical cancer screening. Available in limited geographies, not available in US and China.
• HPV E6, E7 mRNA Probe Ready-to-Use probe for detecting HPV E6 and E7 mRNA expression, used in cervical cancer screening and diagnostics. Regulated as Analyte Specific Reagent (ASR).
• CMV mRNA Probe CMV mRNA Probe for detection of Cytomegalovirus mRNA expression in cells. Regulated for Research Use Only (RUO).
• incellPREP Tissue Single Cell Suspension System IVD/CE-IVD certified homogenizer system for preparing single cell suspensions from tissue samples for downstream analysis, including sample rack and battery pack components.
• BioINK PD-L1 CTC Core Kit Research use only kit for detecting PD-L1 expression on circulating tumor cells (CTCs) for cancer research applications.
• Hybridization Core Reagents Core reagents for in situ hybridization procedures, sold as bulk format for general laboratory use. Regulated as General Purpose Reagent (GPR).
• HPV Control Cells Control cells for HPV testing validation and quality control in laboratory settings. Regulated for Research Use Only (RUO).
• incellMAX Fix/Permeabilizer reagent for cell fixation and permeabilization, enabling intracellular staining for single cell analysis. Regulated as General Purpose Reagent (GPR).
• incellMAX C Fixative reagent for preserving cell samples prior to analysis. Regulated as General Purpose Reagent (GPR).
• Cell Cycle Dye Reagent for cell cycle analysis and DNA content measurement. Regulated as General Purpose Reagent (GPR).
• CytoStat triCHROME CE-IVD certified reagent kit for multi-color cell analysis and diagnostics.
• Anti PD-L1 Antibody Antibody for PD-L1 detection, used in cancer immunotherapy assessment and diagnostics. Regulated as Analyte Specific Reagent (ASR).
• Anti CD45 Antibody Antibody for CD45 (leukocyte common antigen) detection used in cell identification and hematological diagnostics. Regulated as Analyte Specific Reagent (ASR).
• Anti Pan Cytokeratin Antibody for pan-cytokeratin detection used in epithelial cell identification and cancer diagnostics. Regulated as Analyte Specific Reagent (ASR).

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• NanoString Technologies: Spatial biology and single cell analysis company (GeoMx, CosMx, nCounter). Comparable to IncellDx in multiplexed RNA in situ hybridization and oncology biomarker profiling, with overlapping research customer base.
• 10x Genomics: Single cell genomics and multi-omics platform company offering Chromium single cell assays and Visium spatial products. Closely comparable to IncellDx because both sell single cell analysis solutions to research and clinical lab customers, though 10x is instrument-platform-led.
• Bio-Techne: Life science reagents and diagnostics company with RNAscope in situ hybridization products and protein biology reagents. Directly comparable to IncellDx because of overlapping multiplex RNA ISH technology and shared research and clinical lab customers.

Broad incumbents

• Hologic: Major women's health diagnostics company with a leading HPV testing portfolio (Aptima). Comparable to IncellDx because it operates in the HPV molecular diagnostics and cervical cancer screening market, the same clinical use case targeted by HPV OncoTect 3Dx.
• Roche Diagnostics: Global IVD and HPV diagnostics leader (cobas HPV test) and a major player in tissue-based companion diagnostics. Directly comparable to IncellDx in HPV cervical cancer screening and oncology IVD, with substantially broader scale and regulatory footprint.
• Qiagen: Global molecular diagnostics and sample preparation company with HPV tests and the QIAsymphony automation platform. Comparable to IncellDx because of its HPV testing franchise and its sample-prep consumables business, which overlaps with incellPREP.
• Becton Dickinson (BD): Large diagnostics and life sciences company with BD Onclarity HPV assay and significant flow cytometry and single cell analysis capabilities. Comparable to IncellDx in HPV diagnostics and in multiplexed single cell analysis workflows.
• Abbott Diagnostics: Major IVD player with HPV and infectious disease molecular tests. Comparable to IncellDx in the HPV and infectious disease molecular diagnostics market, particularly for HPV cervical screening and CMV testing.
• Cepheid (Danaher): Molecular diagnostics company with the GeneXpert platform offering HPV, CMV, and other infectious disease tests. Comparable to IncellDx in clinical molecular diagnostics for HPV and CMV, with much broader installed instrument base.

Emerging players

• RareCyte: Specialized single cell and circulating tumor cell analysis company. Comparable to IncellDx because both focus on single cell and CTC workflows, with overlapping oncology research and translational customer segments.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/incelldx
• Facebookfacebook.com/194410977270675
• LinkedInlinkedin.com/company/incelldx

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds3 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 IncellDx