Wuhan HealthCare Biotechnology Co., Ltd.

What Wuhan HealthCare Biotechnology Co., Ltd. does

Wuhan HealthCare Biotechnology Co., Ltd. (武汉康录生物技术股份有限公司) is a privately held Chinese molecular diagnostics company founded in February 2013 and headquartered in Wuhan's Optics Valley Precision Medicine Industry Park. The company develops, manufactures, and commercializes rapid Fluorescence In Situ Hybridization (FISH) probe technology and automated FISH processing instrumentation for the diagnosis of cancer and cardiovascular-cerebrovascular diseases. Its proprietary core technology reduces FISH hybridization time from a conventional 16 hours to 2 hours, and total detection time from 3 days to a few hours, using non-repetitive sequence probe design (300-500 bp vs. 600+ bp conventional). The product ecosystem comprises the TL-101 automated pretreatment system, the KL-200P fully automated FISH processing system, and the S2400 FISH slides scanner with AI-assisted interpretation, collectively enabling a same-day, end-to-end automated FISH workflow. The company's portfolio spans over 500 FISH items and 100+ IVDR certified products covering blood cancer panels (BCR/ABL, AML1/ETO, PML/RARA, MLL), solid tumor panels (HER2, ALK, ROS1, RET, NTRK, MYC, BCL2, BCL6), and pharmacogenomics PCR tests.

The company's revenue model spans four streams: (1) sale of FISH probe products and reagent kits, (2) sale of automated instruments (TL-101, KL-200P), (3) recurring reagent consumables that generate pull-through revenue from the installed instrument base, and (4) third-party medical testing services via its wholly-owned subsidiary Kanglu Medical Testing Laboratory (武汉康录医学检验实验室), which provides PCR, cytogenetics (Karyotype, FISH), and NGS-based testing to hospitals nationwide. Go-to-market is sales-led, combining direct sales to hospital pathology and oncology departments with international distribution partnerships covering 30+ countries and regions (including 20+ European and American markets). The company holds multiple NMPA Class III registrations, CE marks on 43 products, ISO 13485 and ISO 9001 certifications, and operates with a venture-backed ownership structure following Series A (2017) and Series B+ (2021) financings. It has been designated a National 'Little Giant' Enterprise by MIIT and a Hubei Provincial Listed Reserve Seed Enterprise, signaling its IPO-track trajectory.

Name

Wuhan HealthCare Biotechnology Co., Ltd.

Legal name

Wuhan HealthCare Biotechnology Co., Ltd.

Website

https://healthcare-biotech.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

Wuhan HealthCare Biotechnology is a Chinese molecular diagnostics company developing proprietary rapid FISH probe technology and automated FISH processing instruments (TL-101, KL-200P, S2400) for cancer diagnosis, serving 700+ domestic hospitals and exporting to 30+ countries.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Medical Equipment and Supplies Manufacturing (3391), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826), Services-Medical Laboratories (8071)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD), Microscopy, Imaging & Flow Cytometry Instruments (HLAGAIAE)

Keywords

• Fluorescence in situ hybridization
• Molecular diagnostic reagents
• Automated FISH systems
• Cancer diagnostic products
• Cytogenetic testing services

Headquarters

HQ city

Wuhan

HQ country

China

HQ region

Asia

Offices1 record

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. FISH Probe Products: Sale of rapid FISH probes and reagents. Products include over 500 comprehensive FISH items and 100+ IVDR certified products. Revenue from direct product sales to hospitals and laboratories.
2. Automated FISH Instruments: Sale of automated FISH processing equipment including TL-101 pretreatment system and KL-200P fully automated FISH system.
3. Medical Testing Services: Third-party medical testing laboratory services (康录医学检验实验室) providing comprehensive testing services including blood oncology, solid tumor, and pharmacogenomics testing. Testing platforms include PCR, cytogenetics (Karyotype, FISH), and NGS.
4. Reagent Consumables: Recurring revenue from配套 reagents and consumables for FISH testing including pretreatment reagents, probe solutions, and supporting chemicals.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Wuhan HealthCare Biotechnology Co., Ltd. develops, manufactures, and sells a proprietary portfolio of rapid Fluorescence In Situ Hybridization (FISH) diagnostic products for clinical and pathology laboratories. Its offerings span FISH probe reagents (500+ items covering blood cancers and solid tumors), automated FISH pretreatment and processing instruments (TL-101, KL-200P), a fluorescence slide scanner with AI interpretation (S2400), and complementary PCR-based pharmacogenomics products. It also operates a subsidiary third-party medical testing laboratory (Kanglu Medical Testing Laboratory) providing blood tumor, solid tumor, and pharmacogenomics testing services to hospitals across China.

Product overview

Wuhan HealthCare Biotechnology Co., Ltd. (康录生物) offers a comprehensive FISH diagnostic portfolio centered on its proprietary Fast FISH Technology platform. The product ecosystem comprises three automated processing devices: the TL-101 (FISH Slides Automatic Pretreatment System) for automated sample preparation, the KL-200P (Fully Automatic Fluorescence In-Situ Hybridization System) for fully automated FISH testing from slides to staining completion, and the S2400 (FISH Slides Scanner System) for automated imaging and AI-assisted result interpretation. These three devices form an integrated workflow enabling rapid, automated, and intelligent FISH testing. The company also provides a broad menu of FISH probe kits covering 500+ items for blood cancers and solid tumors, along with pharmacogenomics PCR detection products for personalized medicine applications. The company reports 100+ IVDR certified products and serves customers in more than 30 countries.

Differentiator

Problem solved

Functional benefit

Products and services

• FISH Slides Automatic Pretreatment System (TL-101) Fully automates all FISH pre-processing steps in 3 hours, integrating baking, dewaxing, permeabilization (boiling), enzymatic digestion, and dehydration into a single platform with throughput of 80-100 sample slides per day for hospital pathology and clinical laboratories.
• Fully Automatic Fluorescence In-Situ Hybridization System (KL-200P) Fully automated FISH workflow from unstained tissue slides to FISH staining completion with no manual intervention required, featuring automated pre-hybridization pretreatment, micro-volume probe dispensing (10 µL/test), automated coverslip placement/removal, post-hybridization washing, and DAPI staining; achieves 5-hour report turnaround.
• FISH Slides Scanner System (S2400) Fully automated system for fluorescent scanning and AI-assisted FISH result interpretation of fluorescence-labeled tissue or cell sections, providing high-throughput testing, automated scanning, high-resolution imaging, multi-channel imaging, digital storage, remote sharing, and AI-powered automated interpretation for hospital pathology and oncology laboratories.
• Fast FISH Probe Technology Platform Proprietary rapid FISH probe technology using non-repetitive sequence design (300-500 bp probe length) that reduces hybridization time from 16 hours to 2 hours and delivers clear signals, precise localization, and low background noise, used as the reagent foundation across the company's blood cancer and solid tumor panels.
• Blood Cancer FISH Detection Panel Comprehensive FISH detection panel for hematologic malignancies covering AML, CML, ALL, CLL, MDS, MM, and CMML, including gene fusions, rearrangements, deletions, and chromosomal abnormalities such as BCR/ABL, AML1/ETO, PML/RARA, and MLL rearrangements, for hospital pathology and oncology departments.
• Solid Tumor FISH Detection Panel FISH detection panel for solid tumors including breast cancer (HER-2, TOP2A), lung cancer (ALK, ROS1, RET, NTRK), lymphoma (MYC, BCL2, BCL6), and various sarcomas, covering gene amplifications, rearrangements, fusions, and deletions for oncology diagnostics.
• Pharmacogenomics PCR Detection Products PCR-based pharmacogenomics test kits supporting drug response guidance including CYP2C19 (clopidogrel), VKORC1/CYP2C9 (warfarin), ALDH2 (alcohol/nitroglycerin), MTHFR (folate), ApoE (statin), and GP IIIa/GP1BA/PEAR1 (aspirin) gene polymorphism detection for personalized medicine.
• Third-party Medical Testing Laboratory Services (Kanglu Medical Testing Laboratory) Third-party medical testing laboratory services (武汉康录医学检验实验室有限责任公司) providing comprehensive testing including blood oncology, solid tumor, and pharmacogenomics testing across PCR, cytogenetics (Karyotype, FISH), and NGS platforms for disease warning, prevention, early diagnosis, individualized treatment selection, efficacy observation, prognosis judgment, and recurrence monitoring to hospitals nationwide.

Quantifiable outcome

• Hybridization time reduced from 16 hours to 2 hours
• +5 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature6 records

Partnerships

One partnership is on record.

• Toujing Life - Pathology Business Strategic Development PlatformcoreStrategic or Co-development Partner · 1 January 2025Wuhan HealthCare Biotechnology became the Strategic Development Platform for the Pathology Business Segment of Toujing Life in 2025, representing a significant strategic partnership in the pathology diagnostics space.

Scale indicators11 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Abbott Molecular: Abbott Molecular is the global leader in FISH probe kits for oncology (ALK, HER2, ROS1, BCR/ABL, etc.) and offers the VP 2000 automated FISH processor. Directly competes with Wuhan HealthCare's FISH probe menu and is the dominant FISH vendor in Western hospital labs.
• BioGenex: BioGenex is a US-based company offering automated FISH processing systems (e.g., Xmatrx, i6000) and ISH probe reagents. Directly competes with Wuhan HealthCare's TL-101 pretreatment and KL-200P FISH automation systems in pathology lab workflows.
• ZytoVision: ZytoVision (Germany) provides FISH probes, ZytoLight/ZytoFast reagent kits, and automated FISH processing instruments (e.g., FISHolution). It targets the same pathology and cytogenetics end-users as Wuhan HealthCare, particularly in European accounts, and competes head-to-head on probe menu breadth and IVDR/CE compliance.
• MetaSystems: MetaSystems is a German manufacturer of automated FISH scanning/imaging platforms (e.g., Metafer, Zeiss-compatible) and FISH probe software. It is the closest direct competitor to Wuhan HealthCare's S2400 scanner + KL-200P automated FISH workflow and competes for the same hospital cytogenetics and pathology customers globally.
• Empire Genomics: Empire Genomics is a US-based FISH probe manufacturer for cancer and constitutional cytogenetics. It is a smaller specialty competitor comparable to Wuhan HealthCare in product type (FISH probes) and customer base (clinical cytogenetics labs), though with more limited automation offerings.
• Cytocell (Oxford Gene Technology): Oxford Gene Technology's Cytocell line is a leading FISH probe manufacturer for hematology and solid tumors, distributed globally. Comparable to Wuhan HealthCare's blood cancer and solid tumor FISH panels and competes in both China and Western distributor channels.
• CytoTest Inc. CytoTest is a US-China FISH probe manufacturer offering IVD FISH probe kits for hematologic malignancies and solid tumors. Comparable product line to Wuhan HealthCare's blood cancer and solid tumor FISH panels and a direct competitor in China and international tendering.

Broad incumbents

• Leica Biosystems (Danaher): Leica Biosystems, part of Danaher, is a broad pathology incumbent offering FISH probes (via Kreatech heritage), automated stainers, and imaging platforms. It competes with Wuhan HealthCare across the FISH workflow and has far larger global sales/service reach, though FISH is one of many product lines rather than its focus.
• Roche Diagnostics (Ventana): Roche/Ventana is the dominant tissue-diagnostics incumbent offering ISH/FISH assays (e.g., ALK D5F3, HER2 Dual ISH) on automated platforms (BenchMark XT/Ultra). Comparable customer base in hospital pathology, but operates as a broad IHC/ISH/molecular diagnostics franchise rather than a FISH pure-play.

Regional players

• Master Diagnóstica: Master Diagnóstica (Spain) develops FISH probes and automated FISH platforms (e.g., FISH-TryOn), primarily serving European and Latin American hospital markets. Comparable to Wuhan HealthCare in FISH product scope but with a more regional, distributor-led commercial model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/wuhan-healthcare-biotechnology-co-ltd

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

Funding overview

Funding rounds

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 Wuhan HealthCare Biotechnology Co., Ltd.