What RainSure Scientific does

RainSure Scientific designs and manufactures molecular diagnostic instruments and assay kits, with a product portfolio centered on digital PCR (dPCR) and quantitative PCR (qPCR) platforms. The company's instrument lineup includes the RS32 All-in-One dPCR Systems and DropDx Two-Unit dPCR Systems (both CE-IVDR certified for clinical use) and the Fast-16 qPCR Systems, a portable field-deployable instrument with an optional battery pack. Underlying technology combines in-house expertise across microfluidics, optics, and software to deliver integrated sample preparation, amplification, and analysis in compact form factors. Assay offerings include the Fastplex BCR-ABL (p210) %IS digital PCR Kit for leukemia monitoring, a CE-IVD Sepsis Pathogenic Microorganism Detection Kit, and Human EGFR Gene Mutation Detection Assays, supported by qPCR/dPCR assay kits and lyophilized mastermix reagents; manufacturing occurs at ISO 13485 certified sites.

The company serves three primary customer segments: clinical diagnostic laboratories (requiring CE-IVD compliant systems), research laboratories (using RUO products), and point-of-care/field testing settings. Revenue is generated through two streams — instrument sales (dPCR and qPCR platforms) and recurring consumables (assays, kits, and reagents) — priced on a quote basis without public disclosure. RainSure operates four R&D centers, ten specialized research teams, and a global distribution network of 20 partners and distributors, with corporate headquarters in San Jose, California and origins in Suzhou, China. The company was founded in 2017 and has raised approximately $4M across three funding rounds (2018, 2019, 2022) from investors including Future Capital Discovery Fund, BioVenture, Volcanics Venture, Haoyue Capital, and Qiandao Fund.

Name

RainSure Scientific

Legal name

RainSure Scientific

Website

https://rainsureglobal.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

101–250 employees

Short description

RainSure Scientific designs and manufactures digital PCR and quantitative PCR instruments plus molecular diagnostic assays for clinical laboratories and research institutions. Founded 2017, the company sells CE-IVDR certified products globally through a network of 20 distributors.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics Instruments

NAICS

Analytical Laboratory Instrument Manufacturing (334516), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Laboratory Analytical Instruments (3826), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Molecular Biology & Genomics Instruments (PCR/qPCR, Sequencing, Microarrays) (HLAGAIAF)

akta.pro secondary industries

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

Keywords

• Molecular diagnostics instruments
• Digital PCR platforms
• QPCR systems
• Clinical assay kits
• Nucleic acid detection

Headquarters

HQ city

Suzhou

HQ country

China

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. dPCR and qPCR Instruments: Sale of digital PCR and quantitative PCR instrument platforms including RS32 All-in-One dPCR Systems, DropDx Two-Unit dPCR Systems, and Fast-16 qPCR Systems. Instruments are sold with both RUO (Research Use Only) and CE-IVD regulatory designations.
2. Assays and Kits: Sale of specialized molecular diagnostic assays and kits including Fastplex BCR-ABL (p210) %IS digital PCR Kit, Sepsis Pathogenic Microorganism Detection Kit, Human EGFR Gene Mutation Detection Assays, and general qPCR/dPCR assay reagents. These consumables provide recurring revenue through repeat purchases.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels2 records

Core offering

RainSure Scientific designs and manufactures digital PCR (dPCR) and quantitative PCR (qPCR) instrument platforms — including the RS32 All-in-One dPCR System, DropDx Two-Unit dPCR System, and Fast-16 qPCR System — along with associated molecular diagnostic assay kits, reagents, and lyophilised mastermix. Products are offered in both Research Use Only (RUO) and CE-IVDR/CE-IVD certified configurations for clinical diagnostic laboratories, research institutions, and point-of-care settings.

Product overview

RainSure Scientific offers a portfolio of molecular diagnostic instruments and assay kits. The product line comprises two main instrument platforms (RS32 All-in-One dPCR Systems and DropDx Two-Unit dPCR Systems for digital PCR, plus Fast-16 qPCR Systems for quantitative PCR) complemented by a range of assay kits including Fastplex™ BCR-ABL (p210) %IS digital PCR Kit, Sepsis Pathogenic Microorganism Detection Kit (dPCR), and Human EGFR Gene Mutation Detection Assays. The company also provides qPCR Assays & Kits, dPCR Assays & Kits, and Lyophilised Mastermix. Their portfolio includes both Research Use Only (RUO) and CE-IVD certified clinical offerings, manufactured under ISO 13485 certified standards.

Differentiator

Problem solved

Functional benefit

Brands

• FastPlex: Brand for Fastplex™ digital PCR kits including BCR-ABL (p210) %IS digital PCR Kit for leukemia monitoring
• DropDx

Products and services

• RS32 All-in-One dPCR Systems (CE-IVDR) Compact digital PCR platform combining sample preparation, amplification, and analysis in a single, easy-to-use instrument, designed for clinical diagnostic laboratories requiring CE-IVDR certified molecular diagnostic workflows.
• DropDx Two-Unit dPCR Systems (CE-IVDR) Reliable clinical diagnostic digital PCR system designed for accurate molecular diagnostics with CE-IVDR regulatory compliance, targeted at clinical laboratories performing routine diagnostic testing.
• Fast-16 qPCR Systems Field-ready quantitative PCR instrument with optional battery pack for rapid, robust sample detection in laboratory, point-of-care, and remote field locations.
• Fastplex™ BCR-ABL (p210) %IS digital PCR Kit High-precision digital PCR kit for quantifying BCR-ABL(p210) transcript levels, supporting effective monitoring of leukemia patients in clinical diagnostic workflows.
• Sepsis Pathogenic Microorganism Detection Kit (dPCR) (CE-IVD) Sensitive and fast digital PCR assay kit for detecting key sepsis-causing pathogens, providing CE-IVD certified clinical diagnostic results to support timely clinician decision-making.
• Human EGFR Gene Mutation Detection Assays Assays (primers and probes) for detecting EGFR gene mutations in tissue DNA and plasma cfDNA, including the clinically significant EGFR-19del variant common in Asian non-small cell lung cancer patients.
• Digital PCR Assays & Kits High-precision, multiplexed digital PCR assays and kits enabling quantification for advanced diagnostics and research applications.
• qPCR Assays & Kits Quantitative PCR assays and kits providing high-resolution, multiplexed detection with industry-leading accuracy and reliability for research and clinical workflows.
• Lyophilised Mastermix Lyophilised (freeze-dried) mastermix reagent designed for molecular diagnostic applications, providing enhanced stability and ease of use with RainSure PCR platforms.

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

Partnerships

One partnership is on record.

• Global Distributor NetworkcoreChannel Partner/ Reseller/ DistributorRainSure Scientific has established a network of 20 global partners and distributors across key markets worldwide. These partners distribute RainSure's molecular diagnostic products including dPCR systems, qPCR instruments, and associated assays and kits. The distributor network enables regional sales and support across different geographic markets.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Standard BioTools (formerly Fluidigm): Developer of the Biomark HD and Juno dPCR/qPCR systems using microfluidics-based partitioning. Comparable as a specialty dPCR/qPCR instrument vendor serving translational research and clinical workflows.
• Lexogen: Molecular biology tools vendor offering qPCR/dPCR assays, reagents, and library prep kits. Comparable as a specialty molecular reagents and assays vendor serving research and translational labs.
• Stilla Technologies: Specialist in chip-based digital PCR (Naica system) with a similar focus on clinical dPCR applications and a comparable instrument-plus-consumables model. Most direct head-to-head competitor in clinical dPCR.
• JN Medsys: Developer of the Clarity dPCR system using chip-based partitioning. Comparable as a focused dPCR instrument vendor with clinical-applications positioning.
• Bioneer: Korean molecular diagnostics company with Exicycler qPCR and AccuPower dPCR instruments and IVD kits. Comparable as a regional dPCR/qPCR instrument-and-assay specialist expanding globally.

Broad incumbents

• QIAGEN: Major molecular diagnostics and sample-preparation vendor with the QIAcuity dPCR system and a broad IVD assay menu. Comparable as a full-stack dPCR instruments-plus-assays competitor.
• Roche Diagnostics: Operates the Digital LightCycler and cobas PCR systems for clinical molecular diagnostics. Comparable as an established clinical PCR and dPCR platform competitor with deep regulatory reach.
• Thermo Fisher Scientific: Operates the QuantStudio and Absolute Q dPCR product lines alongside a vast molecular diagnostics portfolio. Overlaps with RainSure across qPCR and dPCR instruments and assay development.
• Bio-Rad Laboratories: Pioneer of droplet digital PCR (QX200) with the deepest installed base in dPCR instruments and consumables. Directly comparable as the dominant dPCR platform competitor to RainSure's RS32 and DropDx systems.
• Cepheid (Danaher): Operates the GeneXpert system, the dominant clinical point-of-care PCR platform. Comparable in molecular diagnostics commercial reach and CE/FDA-cleared clinical PCR menu, though in a different instrument format.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds3 records

Investors6 records

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 RainSure Scientific