Transforming Molecular Diagnostics

Illuminating Value through Amplification

We envision a future where technology, value, and clinical impact are all amplified. Amplidea is a molecular diagnostics technology company developing next-generation multiplexing solutions that expand the capabilities of standard real-time PCR platforms without requiring expensive hardware upgrades or complex workflows.

"The Brightest Spark in Molecular Diagnostics"

Our mission is to empower laboratories worldwide with innovative, accessible diagnostic solutions that deliver superior clinical outcomes while reducing operational costs and complexity.

Breaking Through PCR Limitations

The Challenge

Modern clinical laboratories face critical constraints with current real-time PCR technology that limit diagnostic capacity and increase operational burden.

  • Restricted Multiplexing: Standard platforms are confined by the number of available fluorescence channels, typically 4-5 targets maximum
  • Escalating Costs: Laboratories must split testing panels across multiple tubes or invest in expensive dedicated instruments
  • Workflow Complexity: High-plex alternatives require sophisticated software deconvolution and specialized training, creating significant adoption barriers
  • Extended Turnaround Times: Multiple-tube workflows increase processing time and delay critical clinical decisions

The Amplidea Solution

FluoroSplit™ technology powered by our proprietary Thermo-Induced Switching Probe (TISP) platform revolutionizes PCR multiplexing through innovative dual-temperature detection.

2x Capacity

Doubles targets per channel using intelligent thermal switching at 62°C and 84°C readpoints

Zero Hardware Investment

Works seamlessly on existing real-time PCR systems like Bio-Rad CFX96

Intuitive Workflow

No complex mathematical deconvolution or specialized software required

FluoroSplit™ Technology: Thermo-Induced Switching Probe

Our breakthrough Thermo-Induced Switching Probe (TISP) technology separates fluorescence signals by temperature rather than wavelength, enabling distinct target resolution within a single detection channel. This elegant approach doubles multiplexing capacity without adding hardware complexity.


01

Thermal Cycling

Standard PCR amplification occurs with both TISP present in the reaction, targeting different sequences

02

First Detection at 62°C

The lower TISP releases fluorescence, detecting Flu A with high specificity

03

Second Detection at 84°C

The higher TISP releases fluorescence, detecting Flu B independently within the same channel

04

Instant Results

TISP technology doubles the multiplexing capacity of standard PCR platforms without requiring post-run procedures, such as melting curve analysis or algorithmic signal deconvolution.

Technical Advantages

TISP enables temperature-induced signal separation within a single fluorescence channel, operating independently of traditional optical multiplexing. Each probe activates only at its designated acquisition temperature, allowing two fully discriminated real-time signals without software deconvolution or post-run analysis. This introduces a new dimension for expanding diagnostic panels, increasing multiplex capacity on existing PCR instruments without any hardware modification.


Comprehensive Product Pipeline

Flagship Product: FluoroSplit™ RV7 Panel

Our lead product represents a complete respiratory diagnostic solution, detecting seven critical targets in a single optimized tube. The RV7 panel addresses the most common viral respiratory infections with unprecedented efficiency and clinical utility.

Influenza A & Subtyping

Comprehensive detection and subtyping: universal influenza A, seasonal H1, H3, and pandemic pdm2009 strains with high analytical sensitivity

Influenza B

Robust detection of Influenza B covering both Yamagata and Victoria lineages for complete seasonal flu coverage

RSV A & RSV B

Differential detection of both RSV subtypes, critical for pediatric and elderly patient populations

Internal Control

Built-in process control ensures sample integrity, extraction efficiency, and PCR inhibition monitoring

Current Status:

Proof-of-Concept successfully presented at APCCMI 2025 (Abstract Res_296).

Full validation study abstract submitted to ESCMID Global 2026.


Expanding FluoroSplit™ Portfolio

FluoroSplit™ RV8

In Active Development

A high-precision deca-plex panel implemented on 5 fluorescence channels. It integrates dual-gene SARS-CoV-2 detection (E gene, RdRp gene) with the complete RV7 targets (Influenza A H1/H3/pdm09, Influenza B, RSV A/B) in a single reaction.

FluoroSplit™ RV20

In Active Development

Comprehensive 20-target respiratory viral panel including RV7, common cold viruses (Rhinovirus, Coronavirus OC43, 229E, NL63, HKU1), Adenovirus, Parainfluenza 1-4, Bocavirus, human Metapneumovirus, and Enterovirus

Avian Influenza Panel: Detection and Sub-Typing

Development Phase

Targeted detection and subtyping for high-risk avian strains: H5, H7, H9 hemagglutinin types and N1, N6, N8 neuraminidase types. Critical for pandemic surveillance and veterinary diagnostics

Syndromic Panels

Pipeline 2026-2028

  • GI Pathogens: Bacterial, viral, and parasitic gastroenteritis
  • STI Panel: 14 sexually transmitted pathogens including gonorrhea, chlamydia, mycoplasma, trichomonas
  • Vector-borne: Dengue, Zika, Chikungunya, Malaria
  • TB & Drug Resistance: Mycobacterium tuberculosis with rifampicin and isoniazid resistance markers

Why Choose Amplidea?

Amplidea delivers transformative value across technical performance, economic efficiency, and clinical utility. Built on uncompromising analytical accuracy, our solutions are engineered for real-world laboratory environments where cost-effectiveness, reliability, and ease of implementation drive adoption—and where measurable clinical impact is essential.

Cost-Effective Excellence

30-40% reduction in per-test costs through increased target density

  • Single-tube testing eliminates redundant reagent usage
  • No expensive hardware upgrades required (e.g., CFX96 from Bio-Rad)
  • Reduced labor and hands-on time
  • Lower consumables spending per patient result

Universal Compatibility

Zero barrier to adoption with existing equipment

  • Works on all standard open-platform real-time PCR systems
  • Fully Compatible with Bio-Rad CFX96
  • Standard thermal cycling protocols
  • No specialized optical modules needed
  • Does not require any mathematical or software-based signal deconvolution

Proven Scalability

Platform technology applicable across disease areas

  • Respiratory pathogen panels (RV7, RV8, RV20, Avian Influenza)
  • Gastrointestinal syndromic testing
  • Sexually transmitted infection screening
  • Vector-borne disease surveillance
  • Antimicrobial resistance detection

Clinical Excellence

Superior outcomes through optimized workflows

  • Fewer tubes reduce sample handling errors
  • Comprehensive panels improve diagnostic accuracy
  • Simplified result interpretation for clinicians
  • No significant increase in run-time due to rapid thermal switching

Competitive Positioning

Amplidea's FluoroSplit™ technology occupies a unique market position between traditional low-plex PCR and expensive high-plex platforms. We deliver high-plex performance at low-plex economics, making advanced molecular diagnostics accessible to laboratories of all sizes.

Traditional Real-Time PCR

✓ Limited to 4-5 targets

✓ Simple workflow

✓ Multiple tubes required

✓ High per-test reagent cost

Amplidea FluoroSplit™

8-10 targets per tube

Works on standard realtime PCR devices

Does not need mathematical convolution

Simple workflow

Single tube testing

Low per-test cost

High-Plex Systems

✓ 5-12 targets targets per tube

✓ dedicated devices with analysis software

✓ Complex deconvolution

✓ High-cost system

✓ High per-test cost

AmpID™ Traditional Real-Time PCR Line

Complementing our innovative FluoroSplit™ platform, our AmpID™ product line offers validated, high-quality quantitative and qualitative Real-Time PCR kits for routine clinical diagnostics, manufactured under ISO 13485 quality standards. All the products are Research-Use-Only (RUO) only.

Quantitative Detection

Precisely measure viral loads and pathogen quantities for monitoring disease progression and treatment efficacy.

Qualitative Detection

Identify the presence or absence of specific pathogens for accurate diagnosis and screening purposes.

Quantitative Detection Products

  • HBV: Hepatitis B Virus viral load monitoring
  • HCV: Hepatitis C Virus quantification
  • CMV: Cytomegalovirus for transplant monitoring
  • BKV: BK Virus nephropathy screening
  • EBV: Epstein-Barr Virus load assessment
  • PARVO B19 : Parvovirus B19 Virus load assessment

Qualitative Detection Products

  • MTB/NTM: Mycobacterium tuberculosis and non-tuberculous mycobacteria differentiation
  • HPV: High-risk human papillomavirus genotyping
  • STI 12 Panel: Comprehensive sexually transmitted infection screening
  • Tropical Fever Panels: Multi-pathogen febrile illness diagnostics

Milestones & Strategic Roadmap

Amplidea's development trajectory demonstrates rapid progress from company inception to market-ready products. Our roadmap balances aggressive innovation with rigorous regulatory compliance, positioning us for successful commercialization in key global markets.

1

2025: Foundation & Proof of Concept

  • July 2: Amplidea Co., Ltd. officially incorporated in Republic of Korea
  • October: FluoroSplit™ technology platform proof-of-concept successfully presented at Asia Pacific Congress of Clinical Microbiology and Infection (APCCMI 2025), Abstract Res_296
  • Q4: FluoroSplit™ RV7 assay development completed with analytical validation showing LOD ≤100 copies/mL across all targets
  • Q4: Abstract submission to European Congress of Clinical Microbiology & Infectious Diseases (ESCMID Global 2026) featuring multi-site RV7 clinical validation data
  • Q4: ISO 13485:2016 Medical Devices Quality Management System implementation initiated
  • Q4: ISO 9001:2015 Quality Management System certification process commenced
2

2026: Validation & Portfolio Expansion

  • Q1: FluoroSplit™ RV7+ SARS-CoV-2(RV8) assay development completed
  • Q2: FluoroSplit™ RV7 prototype demonstration at ESCMID Global 2026 in Munich, Germany, with live system showcase
  • Q2: Development initiation for FluoroSplit™ RV20 comprehensive respiratory panel
  • Q4: FluoroSplit™ RV20 assay development completed
  • Q4: ISO 13485:2016 and ISO 9001:2015 certifications completed
  • Q4: CE-IVDR conformity assessment testing for RV7 panel including clinical performance studies
3

2027: Portfolio Expansion & Commercial Scale

  • Q2: CE-IVDR conformity assessment testing for RV20 panel including clinical performance studies
  • Q2-Q3: Development initiation for FluoroSplit™ GI and STI assay development
  • Q4: Expansion of manufacturing capacity to 1,000,000 tests/month
  • Strategic partnerships with major IVD distributors in North America, Europe, and Asia
4

2028: Market Entry and Global Expansion

  • Q1: CE-IVDR Approaval of RV7 and RV20
  • Launch of FluoroSplit™ RV20, GI, and STI panels
  • Q2: CE-IVDR conformity assessment testing for FluoroSplit™ GI and STI assay development including clinical performance studies
  • Strategic partnerships with major IVD distributors in North America, Europe, and Asia
  • Development Initiaion of POCT product
  • Manufacturing scale-up to 5,000,000 tests/month

Leadership Team

Amplidea is led by a complementary founding team combining deep expertise in molecular diagnostics, biotechnology innovation, and clinical laboratory medicine. Our leadership brings together decades of experience from academic research, clinical practice, and diagnostic industry commercialization.

Yoon, Jungkwon

Chief Executive Officer & Co-founder


Mr. Yoon brings 15 years of experience in molecular diagnostics business development, international trade, and sales marketing.

He has a strong background in strategic planning and commercialization of IVD products across global markets.

His deep understanding of market dynamics and regulatory landscapes drives Amplidea’s commercial strategy, product positioning, and global expansion efforts.


Kim, Hyunchul, Ph.D.

Chief Technology Officer & Co-founder


Dr. Kim is a molecular diagnostics technology expert with more than 20 years of experience, and is the original developer of the FluoroSplit™ platform.

He has authored numerous publications, holds multiple patents, and has successfully led the development of various IVD kits and RUO products across his career.

The core concept behind the FluoroSplit™ platform originated from his research in multiplex detection.

Lee, Jaehyeon, M.D., Ph.D.

Chief Strategic Officer & Co-founder


Dr. Lee is a board-certified laboratory physician and Associate Professor at Jeonbuk National University Hospital, specializing in clinical microbiology.

With deep experience in evaluating diagnostic technologies and guiding translational research, Dr. Lee plays a key role in shaping Amplidea’s product strategy and clinical validation pipeline.

His leadership bridges frontline clinical insights with innovative molecular diagnostic solutions, strengthening the clinical relevance and impact of Amplidea platform.


Advisory Board

Amplidea benefits from guidance by distinguished advisors in clinical microbiology, regulatory affairs, and venture investment, providing strategic oversight across scientific, regulatory, and commercial domains.

Clinical Microbiology

Leading infectious disease specialists from major academic medical centers providing clinical validation guidance

Regulatory Affairs

Former regulators with EMA, MFDS and FDA experience advising on global registration strategies

Business Development

Executives from major IVD companies with proven track records in diagnostic commercialization

Partner With Amplidea

Join us in transforming molecular diagnostics. Whether you're a laboratory seeking innovative testing solutions, a distributor exploring partnership opportunities, or an investor interested in breakthrough diagnostic technology, we welcome your inquiry.

Amplidea Co., Ltd.

Headquarters & Research Center

(54858)
2F, Suite 2064, 2065, 2066
51-25 Manseongbuk-ro, Deokjin-gu
Jeonju-si, Jeonbuk State
Republic of Korea


General Inquiries
Email: amplidea@amplidea.co.kr

Business Development
Email: amplidea@amplidea.co.kr





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"Amplidea: Amplifying the future of molecular diagnostics through innovation, accessibility, and clinical excellence."

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