What CytoTest does

CytoTest Inc. is a privately-held molecular cytogenetics company founded in 2013 and headquartered in Rockville, Maryland, near the National Institutes of Health. The company designs, manufactures, and commercializes Fluorescence In Situ Hybridization (FISH) probes and supporting instrumentation used to detect chromosomal abnormalities, gene fusions (ALK, ROS1, NTRK1/2/3, BCR-ABL, EML4-ALK), copy number variations, and structural rearrangements in solid tumors and leukemia. Its product portfolio includes locus-specific probes (LSP), chromosome counting probes (CCP), whole chromosome painting probes (WPP), subtelomere probes, custom probes, proprietary fluorophores (CytoRed, CytoOrange, CytoGold, CytoGreen, CytoAqua), microscope filter sets, and the CytoHYB CT500 automated denaturation/hybridization instrument. Products are sold in multiple regulatory formats, including Research Use Only (RUO), U.S. FDA Analyte Specific Reagents (ASR), and CE-IVD reagents.

The company operates a hybrid go-to-market model combining direct e-commerce sales through its website with an exclusive regional distributor network spanning North America (Rainbow Scientific), Europe, China, Russia, India, and Spanish/Portuguese-speaking territories. Manufacturing is dual-sited, with U.S. operations in Rockville and a wholly-owned Chinese subsidiary (Beijing Cytotest Biotechnology Co., Ltd. / 北京康宝盈生物科技有限公司) operating from a GMP Class 3 IVD facility in Beijing Yizhuang Biomedical Park. Revenue is generated primarily through one-time sales of probe kits (in 5, 10, or 20-assay packages), instrument hardware, ancillary reagents, custom probe development services, and facilitated NTRK testing services through partner Nexome Genomics Inc. End customers include clinical cytogenetics laboratories, hospital pathology labs, and academic research institutions.

The company holds ISO 13485:2016 certification and has entered strategic collaborations with CapitalBio Corporation (joint diagnostic assay development), the Uniformed Services University's Center for Prostate Disease Research (CRADA for prostate cancer diagnostics), and Henry M. Jackson Foundation. Ownership remains concentrated with founder and CEO Joseph Cheng, and the company is estimated to employ 1–10 people globally.

Name

CytoTest

Legal name

Cytotest Inc.

Website

https://cytotest.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

CytoTest is a privately-held molecular cytogenetics company that designs and manufactures Fluorescence In Situ Hybridization (FISH) probes, proprietary fluorophores, and supporting instrumentation for cancer diagnostics and genetic disorder detection, serving clinical laboratories, hospitals, and academic research institutions globally.

Ownership category

akta.pro rank

Product category

Molecular Cytogenetics Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)

Keywords

• FISH probe kits
• Molecular cytogenetics diagnostics
• Clinical diagnostic reagents
• Companion diagnostic probes
• Custom probe development

Headquarters

HQ city

Rockville

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. FISH Probes and Reagents: CytoTest generates revenue primarily through the sale of FISH (Fluorescence In Situ Hybridization) probes including locus-specific probes (LSP), chromosome counting probes (CCP), whole chromosome painting probes (WPP), subtelomere probes, centromere probes, and custom probes. Products are sold in various package sizes (5, 10, or 20 assays) and regulatory formats.
2. Instruments and Equipment: Sale of supporting instrumentation including the CytoHYB CT500 denaturation and hybridization system, microscope filter sets (CytoAqua, CytoGold, CytoGreen, CytoOrange, CytoRed, DAPI), and accessories.
3. Ancillary Reagents: Provides accessory reagents for sample pretreatment and post-hybridization wash for optimal performance of FISH probes, including FISH Reagent Kit and Paraffin Pretreatment Reagent Kit.
4. Testing Services: The company facilitates running of NTRK1, 2 and 3 testing services in partnership with Nexome Genomics Inc.

Pricing tiers

Go-to-market motion3 records

Distribution channels6 records

Marketing channels4 records

Core offering

CytoTest manufactures and sells Fluorescence In Situ Hybridization (FISH) probes and ancillary reagents for molecular cytogenetics diagnostics. Its catalog includes locus-specific (LSP), chromosome counting (CCP), whole chromosome painting (WPP), subtelomere, centromere, NOR, and telomere probes, plus disease-targeted kits for ALK, ROS1, NTRK1/2/3, EML4-ALK, BCR-ABL, and ETV6-NTRK3 rearrangements. The lineup is rounded out by the CytoHYB CT500 denaturation/hybridization instrument, microscope filter sets in a proprietary fluorophore palette, and reagent kits for sample pretreatment and post-hybridization washing. Products are supplied in RUO, U.S. FDA ASR, and CE-IVD formats, with custom probe development offered on a contract basis.

Product overview

CytoTest is a biotechnology company providing high-quality molecular cytogenetics products centered around Fluorescence In Situ Hybridization (FISH) technology. The product portfolio includes FISH probes for clinical diagnostics (Locus Specific Probes, Chromosome Counting Probes, Whole Chromosome Painting, Subtelomere Probes) and a complete accessory ecosystem. Key diagnostic kits include ALK, ROS1, NTRK1/2/3, EML4-ALK, and BCR-ABL FISH probes for oncology applications. The CytoHYB CT500 instrument automates denaturation and hybridization for slide-based FISH procedures. Supporting products include microscope filter sets (CytoOrange, CytoGreen, CytoRed, CytoAqua, CytoGold, DAPI), FISH Reagent Kits, and Paraffin Pretreatment Reagent Kits. Custom FISH probe development is offered, along with NTRK testing services. Products are manufactured for research use (RUO) and as FDA ASR or CE-IVD reagents, with distribution through Rainbow Scientific in North America.

Differentiator

Problem solved

Functional benefit

Products and services

• ALK Break Apart FISH Probe Kit FISH probe kit containing two differentially labeled Locus Specific Probes covering the 5' and 3' portions of the human ALK gene (2p23.2), designed for clinical cytogenetics laboratories performing lung-cancer rearrangement diagnostics.
• ROS1 Break Apart FISH Probe Kit FISH probe kit labeled with CytoOrange and CytoGreen fluorophores that detects rearrangements involving the human ROS1 gene at chromosome band 6q22.1, intended for clinical cytogenetics laboratories running lung-cancer companion-diagnostic workflows.
• NTRK1 Break Apart FISH Probe Kit FISH probe kit for detecting rearrangements, deletions, or amplifications of the human NTRK1 gene at chromosome band 1q23.1, used by clinical laboratories for papillary thyroid carcinoma diagnostics and pan-solid-tumor NTRK fusion testing.
• NTRK2 Break Apart FISH Probe Kit FISH probe kit for detecting rearrangements, deletions, or amplifications of the human NTRK2 gene at chromosome band 9q21.33, used in clinical cytogenetics for solid-tumor NTRK fusion testing.
• NTRK3 Break Apart FISH Probe Kit FISH probe kit for detecting rearrangements, deletions, or amplifications of the human NTRK3 gene at chromosome band 15q25.3, used by clinical laboratories for solid-tumor NTRK fusion diagnostics.
• ETV6-NTRK3 Dual Fusion/Translocation FISH Probe Kit Dual fusion/translocation FISH probe kit for detecting rearrangements between the human ETV6 and NTRK3 genes, used in clinical diagnostics of acute lymphocytic leukemia and other ETV6-NTRK3-driven malignancies.
• EML4-ALK Fusion Probe FISH probe designed to detect the EML4-ALK fusion associated with non-small-cell lung carcinoma, used by clinical laboratories performing companion-diagnostic workflows for ALK-targeted therapies such as crizotinib.
• BCR-ABL Fusion Probe FISH probe for detecting the BCR-ABL gene fusion used in the diagnosis and monitoring of chronic myeloid leukemia and acute lymphoblastic leukemia by clinical cytogenetics laboratories.
• Custom FISH Probes Custom design and manufacturing of FISH probes where customers specify the genes of interest, enabling laboratories and research groups to develop novel diagnostic reagents in collaboration with CytoTest's R&D team.
• Cytogenetics Research Probe Reagents (Centromere, Telomere, NOR, LSP, WPP, Subtelomere, Pan) A consolidated research-grade FISH probe family encompassing pan-centromeric probes (CCP), pan-telomeric probes (TTAGGG)n, NOR locus-specific probes, locus-specific probes (LSP), whole chromosome painting probes (WPP), subtelomere probes, and pan probes (centromere + NOR + telomere) for numerical and structural chromosomal analysis in research and cytogenetics workflows.
• CytoHYB CT500 Denaturation and Hybridization Instrument Programmable automated slide-based FISH denaturation and hybridization instrument with touchscreen programming, USB port, rapid heating, and four operating modes; designed for up to 12 slides simultaneously and intended for clinical and research cytogenetics laboratories standardizing FISH workflows.
• CytoTest Microscope Filter Sets (CytoRed, CytoOrange, CytoGold, CytoGreen, CytoAqua, DAPI) Matched single band-pass filter sets for fluorescence microscopy covering DAPI, CytoOrange, CytoGreen, CytoRed, CytoAqua, and CytoGold channels, with excitation and emission specifications tuned to CytoTest's proprietary fluorophore palette and industry-standard microscope filter cubes.
• FISH Reagent Kit Reagent kit containing 20X SSC Salt, DAPI counterstain, and NP-40 used as accessory reagents for sample pretreatment and post-hybridization washing to optimize performance of CytoTest FISH probes in cytogenetics workflows.
• Paraffin Pretreatment Reagent Kit Reagent kit for FFPE specimen processing prior to FISH hybridization, containing Pretreatment Solution, Protease Buffer, Protease, SSC Salt, DAPI counterstain, and NP-40 for use in clinical and research cytogenetics workflows involving paraffin-embedded tissue.
• NTRK1, 2 and 3 Testing Service Testing service that detects NTRK gene fusions, delivered by partner Nexome Genomics Inc. using CytoTest probes on FISH and NGS platforms, giving clinical customers access to NTRK1, NTRK2, and NTRK3 fusion testing without in-house assay development.

Quantifiable outcome

• ISO 13485:2016 certification with no open findings during transition audit
• +1 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core, major and supporting.

• Rainbow Scientific Inc.coreChannel Partner/ Reseller/ Distributor · 1 January 2020Exclusive distribution agreement appointing Rainbow Scientific as the exclusive North American distributor for CytoTest's extensive range of FISH probes and ancillary reagents. Rainbow Scientific has over 23 years of commercial cytogenetic experience marketing, selling, and supporting laboratory products to clinical and research labs. The partnership was reappointed in March 2021.
• CapitalBio CorporationmajorStrategic or Co-development Partner · 2 February 2016Non-exclusive strategic collaboration for joint development of molecular diagnostic assays, instrumentation, and services. Initial focus on diagnostic and prognostic test systems for oncology and prenatal applications, with plans to expand to early detection methods, non-invasive testing, and precision medicine tools. Collaboration includes manufacturing certain products in China leveraging CapitalBio's engineering and manufacturing capabilities.
• Uniformed Services University of the Health Sciences (USU) - Center for Prostate Disease ResearchmajorStrategic or Co-development Partner · 30 March 2015Cooperative Research and Development Agreement (CRADA) for development of next-generation approaches to prostate cancer diagnosis and prognosis. CytoTest provides reagents, instrumentation, manufacturing, scale-up, biomarker screening services, and assay construction capabilities. CPDR has discovered genetic and biochemical prostate cancer markers with potential for early diagnostic or prognostic indicators.
• Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF)supportingStrategic or Co-development PartnerNon-profit organization authorized by U.S. Congress that administers CPDR (Center for Prostate Disease Research) program of USU's Department of Surgery. Supports medical research and education at USU and throughout the military medical community.
• Nexome Genomics IncsupportingTechnology or IntegrationNexome Genomics Inc uses CytoTest probes on their FISH and NGS platforms for running NTRK1, 2 and 3 testing services. This partnership enables access to testing services for customers using CytoTest products.

Scale indicators3 records

Recent moves8 records

Expansion highlights7 records

Broad incumbents

• Agilent Technologies (FISH/DNA Microarray): Provides oligo-based FISH/CISH reagents, CGH/SNP microarrays, and molecular pathology tools used in cytogenetics labs. Overlaps with CytoTest in cytogenetics reagent technology, with greater resources and broader platform reach.
• NeoGenomics Laboratories: U.S. specialty clinical laboratory offering cytogenetics, FISH, and molecular oncology testing services. Adjacent rather than directly competitive, but services customers and drives FISH probe demand for vendor partners.
• Bio-Techne (ExoDx / FISH Reagents): Diversified life science tools company selling reagents and assay kits, including cytogenetics and molecular pathology products. Broader portfolio incumbent with overlapping FISH reagent and ancillary reagent offerings.
• Abbott Molecular (Vysis): Established diagnostic division of Abbott offering Vysis-brand FISH probes (ALK, ROS1, BCR-ABL, etc.) as part of a broader molecular diagnostics portfolio. Larger incumbent competing on the same oncology indications with greater commercial scale.
• PerkinElmer (Revvity): Large life science and diagnostics company offering a broad molecular cytogenetics and IVD portfolio, including FISH and related reagents. Indirect competitor with overlapping clinical lab customers and broader capital base.

Direct peers

• MetaSystems: Specialty manufacturer of FISH probes, automated FISH imaging systems, and molecular cytogenetics software for clinical and research cytogenetics labs. Direct competitor to CytoTest across the same probe portfolio and customer base (clinical cytogenetics labs).
• Empire Genomics: U.S.-based FISH probe manufacturer focused on clinical and research cytogenetics, including custom probe development and oncology-focused assays (e.g., ALK, ROS1, NTRK, BCR-ABL). Closely comparable niche competitor with overlap in products and customer segments.
• Cytocell (Oxford Gene Technology / Sysmex): Developer and manufacturer of FISH probe kits for constitutional and oncology cytogenetics, including CE-IVD marked IVD products. Direct competitor with comparable multi-format regulatory positioning (RUO/IVD) and clinical lab customers.

Regional players

• Amoy Diagnostics: China-based molecular diagnostics company specializing in oncology companion diagnostic kits including ALK, ROS1, and other FISH/NGS fusion assays. Comparable FISH-oncology portfolio competing with CytoTest primarily in the China market.

Emerging players

• Oxford Nanopore Technologies: Long-read sequencing platform used for cytogenetics and structural variant detection. Represents the NGS- and sequencing-based substitution risk to FISH probe volumes for indications where CytoTest competes.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries1 record

Funding overview

Funding rounds1 record

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 CytoTest