What Biosan does

Biosan (浙江博圣生物技术股份有限公司, founded 2003, headquartered in Hangzhou) is a privately held Chinese provider of an integrated birth defect prevention and treatment platform covering pre-conception, prenatal, and newborn stages. The company operates two main sub-brands: Biosan Tech (博圣智造), which develops and sells in vitro diagnostic reagents, instruments, and bioinformatics software; and Biosan Medical (博圣医学), which delivers clinical testing services through wholly-owned laboratories in Beijing (2011) and Hangzhou (2017). Its technology stack spans tandem and triple quadrupole mass spectrometry (the MSS MA system, co-developed with Waters Corporation and NMPA-approved in 2022), chromosomal microarray (China's first NMPA-approved CMA prenatal kit, April 2024, commercialized with Thermo Fisher Scientific from September 2024), next-generation sequencing, whole exome sequencing, and proprietary AI platforms including the Newborn Genetic Metabolic Disease AI Risk Assessment Platform (6.74M records, 32 disease models) and the 2025-launched AI Birth Health Intelligent Agent on its BirthMind DCA architecture. Supporting software includes WES-Master, ECS-Master, and the CNV Intelligent Bioinformatics Analysis System.

Biosan sells reagents on a per-test or batch basis to hospitals and screening centers, distributes capital equipment with ongoing service contracts, delivers clinical testing services through its own labs, and supplies information management systems on subscription-style deployments to public health networks. Pricing is not publicly disclosed; commercial agreements with provincial and municipal health commissions are conducted through tender processes for government-sponsored screening programs. The company serves 700+ birth defect prevention centers, newborn screening centers, prenatal diagnosis centers, and prenatal screening agencies across China, with reported cumulative screening exceeding 100 million person-times and approximately 10 million pregnant women and newborns screened annually. Strategic collaborations include GE Healthcare (ViewPoint software integration, 2020), Thermo Fisher (CMA, 2024), Waters Corporation (mass spectrometry), and co-development partner Huiyun Bio (biliary atresia screening). Operational governance is supported by National Engineering Laboratory status (2016), Multiple NMPA approvals, and Hangzhou-based national high-tech enterprise certification.

Geographic footprint is overwhelmingly domestic (China) with nascent international outreach evidenced by Vietnam Ministry of Health engagement in August 2024 and one PCT patent filing on biliary atresia screening. The company completed its 52,000 sqm Biosan Industrial Park headquarters in Hangzhou in February 2025, signaling balance-sheet capacity for further scaling. No external venture capital funding is disclosed in the available data, indicating self-funded or debt-financed growth.

Name

Biosan

Legal name

浙江博圣生物技术股份有限公司

Website

https://biosan.cn

Company type

Private

Founded year

2003

Operating status

Operating

Short description

Biosan is a Hangzhou-based, privately held Chinese IVD and clinical testing platform offering integrated birth defect prevention solutions — reagents, instruments, and AI-powered screening software — to 700+ hospitals and provincial screening centers.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (6215), Medical Laboratories (621511), Analytical Laboratory Instrument Manufacturing (334516)

SIC

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

akta.pro primary industry

Prenatal, Newborn & Reproductive Diagnostics (NIPT, IVF/PGT, newborn screening) (HLAAALAJ)

Keywords

• Molecular diagnostic reagents
• Prenatal screening services
• Newborn genetic testing
• Clinical mass spectrometry
• Birth defect prevention solutions

Headquarters

HQ city

Hangzhou

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, Operations, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. 体外诊断试剂与耗材销售 (IVD Reagents and Consumables): Sales of IVD reagents including prenatal screening reagents (PAPP-A, Free βhCG, PIGF, AFP, uE3), newborn screening reagents (Phe, TSH, 17a-OHP, G6PD, tandem mass spectrometry panels), and diagnostic reagents (CMA kits, NIPT kits, WES capture kits). Products sold to hospitals and medical institutions with pricing based on test volume.
2. 临床检测服务 (Clinical Testing Services): Medical testing services provided through Biosan Medical (博圣医学) clinical laboratories. Services include genetic testing (WES, WGS, NGS panels), biochemical testing (tandem mass spectrometry, urine organic acids), cytogenetics, and carrier screening. Samples collected from partner hospitals and processed in Biosan labs.
3. 医疗设备与平台 (Medical Equipment and Platforms): Sales and service of medical equipment including tandem mass spectrometry systems (MSS MA), automated sample preprocessing systems (AMTS Pre), Cubics Dx automated nucleic acid detection systems, and prenatal screening platforms (DELFIA Xpress, GSP). Equipment sold with ongoing technical support and maintenance services.
4. 信息化解决方案 (Information Technology Solutions): VP servers and information management systems for birth defect prevention networks. Software platforms for prenatal screening workflow management, newborn screening data management, and medical imaging integration. Includes installation, training, and ongoing system support.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Biosan develops, manufactures, and sells in vitro diagnostic (IVD) reagent kits, medical equipment (mass spectrometry and nucleic acid detection systems), and AI/bioinformatics software used by hospitals, screening centers, and government health programs for pre-conception, prenatal, and newborn genetic and metabolic disease screening. The company also operates clinical testing services through its Biosan Medical laboratories, processing samples referred by partner hospitals for genetic, biochemical, cytogenetic, and carrier screening. Its integrated "Birth Defect Prevention and Treatment Total Solution" combines reagents, instruments, clinical lab services, and information management platforms covering the full screening-diagnosis-treatment workflow.

Product overview

Biosan operates as a comprehensive platform provider in China's birth defect prevention and treatment sector, offering an integrated '筛-诊-治' (screening-diagnosis-treatment) total solution platform encompassing five solution pillars: organizational management, laboratory standardization, project operation, quality control, and information management. The product portfolio is organized into two main sub-brands: '博圣智造 (Biosan Tech)' which focuses on in vitro diagnostic reagent kits, medical devices, and software tools; and '博圣医学 (Biosan Medical)' which provides clinical genetic testing services and specialized medical solutions. Core products include the Chromosomal Microarray Chip Detection Reagent Kit (CMA, NMPA-approved in 2024 as China's first of its kind), the Fetal Chromosome Aneuploidy Detection Kit (NIPT), and the Triple Quadrupole Mass Spectrometry System MSS MA (with companion AMTS Pre automated pre-treatment system and Cubics Dx automated nucleic acid system). The platform also includes proprietary AI-driven software tools — the Newborn Genetic Metabolic Disease AI Risk Assessment Platform (reducing screening positive rate from 2–5% to 0.3%), the AI Birth Health Intelligent Agent (enabling automated follow-up and patient management), the CNV Intelligent Bioinformatics Analysis System, WES-Master (WES analysis software), and ECS-Master (expanded carrier screening analysis software) — all integrated within Biosan's full-process digital management information system.

Differentiator

Problem solved

Functional benefit

Brands

• 博圣医学 (Biosan Medical): Provides clinical testing services including biochemical genetics, cell genetics, and molecular genetics testing, as well as genetic counseling services
• 博圣智造 (Biosan Tech)

Products and services

• Chromosomal Microarray Chip Detection Reagent Kit (染色体拷贝数变异检测试剂盒/微阵列芯片法, CMA) NMPA-approved CMA-based reagent kit for prenatal diagnosis, detecting chromosomal aneuploidies (T13, T18, T21, sex chromosomes) and 15q11.2-q13.1 deletions from amniotic fluid samples with 100kb resolution using dual CNV+SNP probe design. Sold to hospitals and prenatal diagnosis centers.
• Fetal Chromosome Aneuploidy Detection Kit (NIPT Kit, 胎儿染色体非整倍体检测试剂盒) NIPT reagent kit for qualitative detection of fetal free DNA from peripheral blood plasma of high-risk singleton pregnant women (gestational age 12+0–22+6 weeks). Uses reversible terminator sequencing to detect trisomy 21 (PPV 96%), trisomy 18 (PPV 88%), and trisomy 13 (PPV 60%).
• Triple Quadrupole Mass Spectrometry Detection System MSS MA (三重四极杆质谱检测系统) Domestically manufactured tandem mass spectrometry system developed with Waters Corporation. Features 18,000 psi pressure tolerance, 12×96-well plate capacity, anti-clogging design, and integrated MassLynx control software with dedicated newborn screening module. Supports newborn genetic metabolic disease screening, lysosomal storage disease screening, MMA second-tier screening, Hcy testing, amino acid profiling, vitamin detection, bile acid profiling, and catecholamine detection.
• Genetic Metabolic Sample Pre-treatment System AMTS Pre (遗传代谢样本前处理系统) Automated pre-treatment system for genetic metabolic sample analysis using liquid chromatography-tandem mass spectrometry. Consists of sample dispensing, sealing, oscillating incubation, and transfer modules controlled by dedicated software to achieve full automation of tandem mass spectrometry pre-treatment workflows.
• Automated Nucleic Acid Detection Reaction System Cubics Dx (全自动核酸检测反应体系构建系统) Automated nucleic acid testing system with 4 independent channels (sampling, magnetic separation, temperature control, mobile platform modules). Completes nucleic acid extraction, library construction, and product purification within 2 hours in a single cartridge-based workflow with no human supervision. Intelligent system management software enables multi-unit serial control.
• Newborn Genetic Metabolic Disease AI Risk Assessment Platform (新生儿遗传代谢病人智能疾病风险评估平台) AI-powered risk assessment platform using machine learning models trained on 6.74 million screening records and 2,167 confirmed case data covering 32 genetic metabolic diseases. Reduces initial screening positive rate from 2–5% to 0.32%.
• AI Birth Health Intelligent Agent (AI出生健康智能体) Proprietary AI intelligent agent system functioning as a four-in-one network: personal health butler for pregnant women (NLP-based Q&A), AI assistant for physicians (automated risk flagging and patient management), data cockpit for department heads (predictive analytics), and smart hub for regional maternal-child networks (intelligent triage and resource allocation).
• CNV Intelligent Bioinformatics Analysis and Interpretation System (拷贝数变异智能生信分析解读系统) Self-developed automated software for copy number variation analysis and clinical interpretation. Supports automated QC, review, ACMG guidelines-based pathogenicity scoring, and one-click report generation. Compatible with both CMA and CNV-seq platforms.
• WES-Master Visual WES Online Analysis Software (全外显子组测序在线分析软件) Self-developed visual WES online analysis software with multi-account/multi-location login, sample management, clinical phenotype keyword extraction, variant filtering and classification, ACMG pathogenicity calculator, IGV and BAM file visualization, real-time CNV-seq data analysis, role-based data management, VCF/BAM file export, and clinical report editing.
• ECS-Master Expanded Carrier Screening Visualization Software (扩展性携带者筛查可视化分析软件) Self-developed visualization software for expanded carrier screening data analysis and reporting. Supports multi-technology platforms and intelligent analysis/reporting workflows.
• Biliary Atresia Screening Reagent Kit (胆道闭锁筛查试剂盒, LC-MS/MS) LC-MS/MS-based dried blood spot screening kit for biliary atresia in newborns, developed with Huiyun Bio. Achieves 100% sensitivity and 98.8% specificity. International PCT patent filed; NMPA Class III medical device registration in progress.
• Prenatal Screening Reagent Series (产前筛查试剂系列) Prenatal screening reagents including PAPP-A, Free βhCG, PIGF, AFP, uE3, and prenatal screening serum quality control materials. Used on DELFIA Xpress and SuperFlex chemiluminescence immunoassay systems for second-trimester maternal serum screening.
• Newborn Screening Reagent Series (新筛试剂系列) Newborn screening reagents including Phe, TSH, 17α-OHP, G6PD, tandem mass spectrometry panels for amino acids/carnitines/succinylacetone, hemoglobin assay kit, Vitamin D assay kit, hereditary hearing loss genetic assay kit, G6PD gene detection, and β-thalassemia gene detection reagents, plus quality control materials.
• Second-Tier and Specialty Newborn Screening Reagent Kits Specialty newborn screening kits including Methylmalonic Acidemia (MMA) Second-Tier Screening Reagent Kit (LC-MS/MS), GCMS Urine Organic Acid Full-Quantification Reagent Kit (92 analytes, 30-minute test time), and Full-Spectrum Amino Acid Dried Blood Spot Reagent Kit (43 amino acids via UPLC-MS/MS).
• Birth Defect Prevention and Treatment Total Solution (出生缺陷防治整体解决方案) Biosan's core integrated platform offering a comprehensive birth defect prevention and control solution covering the full lifecycle from pre-conception to newborn screening. Delivered across five pillars: organizational management, laboratory standardization, project operation, quality control, and information management.
• Clinical Testing Services (Biosan Medical 博圣医学) Medical testing services provided through Biosan Medical (博圣医学) clinical laboratories, including genetic testing (WES, WGS, NGS panels), biochemical testing (tandem mass spectrometry, urine organic acids), cytogenetics, and carrier screening. Samples collected from partner hospitals and processed in Biosan labs. Includes genetic counseling services.

Quantifiable outcome

• AI risk assessment reduces positive recall rate from 2-5% to 0.32%
• +4 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability6 records

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Thermo Fisher Scientific (赛默飞世尔科技)coreTechnology or Integration · 5 September 2024Strategic cooperation for chromosomal microarray (CMA) chip product development and promotion. Biosan's CMA kit received NMPA approval in April 2024, with Thermo Fisher providing technology platform support for the product's clinical applications.
• Waters CorporationcoreTechnology or Integration · 1 January 2022Multi-year collaboration resulting in the development of the MSS MA Triple Quadrupole Mass Spectrometry Detection System. Biosan's domestic tandem mass spectrometry system received NMPA approval in 2022, representing a key milestone in domestic IVD development.
• 绘云生物 (Huiyun Bio)coreStrategic or Co-development Partner · 1 January 2022Strategic partnership for mass spectrometry IVD detection technology, particularly bile atresia early screening technology. Jointly developed LC-MS/MS-based bile atresia screening reagent kit with 100% sensitivity and 98.8% specificity.
• GE Healthcare (通用医疗)coreTechnology or Integration · 25 July 2020Strategic partnership for ViewPoint software application in maternal-fetal medicine. Biosan integrated ViewPoint birth defect precise prevention multi-disciplinary data analysis software into its comprehensive solutions. The software provides risk calculation, growth assessment, image processing, structured reporting, and research retrieval capabilities for prenatal ultrasound and diagnosis.
• 中国人民解放军总医院 (301 Hospital)coreStrategic or Co-development PartnerLead institution for 2021 National Key R&D Program 'Single Gene Disease Expanded Carrier Screening New Technology Development Clinical Application Evaluation and Assistance System Construction'. Biosan participates as a key partner, contributing to ECS product development and clinical application research with 15 institutions nationwide.
• 北京协和医院coreStrategic or Co-development PartnerKey academic collaborator for prenatal genetics research and national ECS (Expanded Carrier Screening) projects. Contributed to expert consensus documents and clinical guideline development for prenatal genetic testing.
• 中国出生缺陷干预救助基金会minorGTM or Marketing PartnerCollaboration on rare disease patient assistance programs. Biosan participates in the Boai Funding Program (博爱资助计划), providing whole genome testing at reduced cost for eligible rare disease patients.
• 浙江大学医学院附属儿童医院coreStrategic or Co-development PartnerCollaborative research partner for 13th Five-Year National Key R&D Program sub-project on AI-assisted diagnosis platform for genetic metabolic diseases. Contributed to the development of AI risk assessment models using 6.74 million screening data points.

Scale indicators8 records

Recent moves12 records

Expansion highlights6 records

Broad incumbents

• Illumina: Illumina is the global leader in next-generation sequencing technology that underpins NIPT, expanded carrier screening, and rare disease diagnostics. Its sequencing platforms and IVD reagent partnerships directly enable the prenatal and newborn testing workflows Biosan sells into.
• Hologic: Hologic, through its Diagnostics segment (formerly Gen-Probe and Biotheranostics), is a global leader in women's health diagnostics including NIPT and prenatal screening. It is a broader incumbent with overlapping prenatal screening capabilities but serves a much wider diagnostic portfolio than Biosan.
• Roche Diagnostics: Roche Diagnostics is the world's largest in vitro diagnostics company, with established prenatal screening and newborn screening products (e.g., cobas platform, NIPT through acquired assets). It serves as the dominant broad incumbent across the same hospital channels where Biosan competes.
• PerkinElmer (now Revvity): Revvity (formerly PerkinElmer Life Sciences) supplies newborn screening reagents, mass spectrometry systems, and genetic testing reagents globally. It is a broad incumbent in the prenatal and newborn screening IVD market that Biosan's MS and reagent products are benchmarked against.

Direct peers

• Kingmed Diagnostics: KingMed Diagnostics is one of China's largest third-party medical laboratory networks, providing genetic, biochemical, and anatomic pathology testing services. It overlaps directly with Biosan's clinical testing services arm (Biosan Medical) and competes for hospital genetic testing outsourcing.
• BGI Genomics: BGI Genomics is China's largest genomic sequencing company and a leading provider of NIPT, prenatal screening, and newborn genetic testing services. It competes directly with Biosan across China's prenatal screening, NIPT, and rare disease diagnostics markets, and operates its own clinical laboratories alongside reagent sales.
• Annoroad Gene Technology: Annoroad is a Chinese next-generation sequencing and genetic testing company providing NIPT, PGS/PGD, and rare disease diagnostics for prenatal and newborn screening. It directly overlaps with Biosan's prenatal genetics product line and clinical testing services.
• DaAn Gene (Da An Gene): DaAn Gene is a Chinese IVD manufacturer with strong positioning in PCR-based infectious disease and genetic testing reagents, including prenatal and newborn screening kits. It competes with Biosan in hospital-channel reagent sales for genetic diagnostics across China.
• Berry Genomics: Berry Genomics is a Beijing-based molecular diagnostics company focused on NIPT, chromosomal abnormality detection, and prenatal genetic testing in China. It is one of the closest direct competitors to Biosan in China's prenatal screening and CMA/NIPT reagent business.
• WuXi Diagnostics: WuXi Diagnostics is a Chinese integrated clinical diagnostics platform offering mass spectrometry, genomics, and clinical testing services. Its newborn screening and IVD product portfolio overlaps meaningfully with Biosan's tandem MS and genetic testing offerings.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries5 records

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 Biosan