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
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.
Clinical Impact: A single FluoroSplit™ tube can replace 2-3 conventional tubes, reducing reagent costs by 40-60% and turnaround time by 30-45 minutes per sample batch.
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
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
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: ISO 13485:2016 and ISO 9001:2015 certifications completed
Q2: Development initiation for FluoroSplit™ RV20 comprehensive respiratory panel
Q2-Q3: CE-IVDR conformity assessment testing for RV7 panel including clinical performance studies
Q4: FluoroSplit™ RV20 assay development completed
Q4: GI pathogen and STI 14-plex panel feasibility studies
3
2027: Market Entry & Commercial Scale
Q1: FluoroSplit™ RV7 receives CE-IVDR certification for European market and Commercial launch of RV7 in European Union and Asia-Pacific markets
Q2: CE-IVDR conformity assessment testing for RV20 panel including clinical performance studies
Q2-Q3: FluoroSplit™ GI and STI assay development completed & CE-IVDR conformity assessment test
Q3: Expansion of manufacturing capacity to 1,000,000 tests/month
Q4: Point-of-Care Testing (POCT) platform development initiated for rapid near-patient diagnostics
4
2028: Global Expansion
Launch of FluoroSplit™ RV20, GI, and STI panels
Strategic partnerships with major IVD distributors in North America, Europe, and Asia
POCT product commercialization
Manufacturing scale-up to 5,000,000 tests/month
Regulatory Strategy: Our phased approach prioritizes CE-IVDR certification for rapid European market access, followed by Korean MFDS and US FDA approvals. This strategy enables revenue generation while pursuing broader global registrations.
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 early research in multiplex detection.
This idea has since evolved into a fully realized technology through his continued innovation and close collaboration with the current Amplidea team.
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.
His extensive clinical and research background ensures that our products align with real-world diagnostic needs and clinical workflows.
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