Fapon Biotech Inc. of Dongguan at MEDICA 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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Fapon Biotech Inc.

No. 5 Hualian Road, Taiwan High-Tech Industrial Park, Songshan Lake, 523808 Dongguan
China

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Hall map

MEDICA 2021 hall map (Hall 3): stand A81

Fairground map

MEDICA 2021 fairground map: Hall 3

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Our range of products

Product categories

  • 03  Diagnostic tests
  • 03.05  Infectious immunology testing
  • 03.05.02  Microbiological diagnosis, virology, equipment and systems for

Microbiological diagnosis, virology, equipment and systems for

  • 03  Diagnostic tests
  • 03.06  Genetic testing, molecular diagnostics
  • 03.06.01  DNA testing
  • 03  Diagnostic tests
  • 03.06  Genetic testing, molecular diagnostics
  • 03.06.03  Polymerase chain reaction (PCR)

Our products

Product category: Immuno assay testing

Shine i2000 Fully Automatic CLIA Analyzer

Excellent Performance
  • Up to 200 T/H, First result in ≤ 15 min
  • Batch CV ≤ 3%
Compact & Convenient
  • Volume of 0.51m³, patented technology for highly integrated and simplified design
  • Batch/random/STAT mode available
  • Integrated control panel with machine, all consumable loading in real time
Innovative Design
  • Incubation, washing and detection all-in-one, detection efficiency improved
  • Using automatic intelligent control technology, low instrument failure rate
  • 100+ patented technologies, 100% self-developed
Compatible system
  • Compatible with AE/AP/HRP/ABEI CLIA assay protocol
  • Compatible with immunological reagents and instruments with different parameters and reaction modes

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Product category: Immuno assay testing

Fapon Biotech Shine i1000 Fully Automated CLIA Analyzer

Excellent Performance
  • Up to 120 T/H, First result in ≤ 15 min
  • Batch CV ≤ 3%
Compact & Convenient
  • Volume of 0.2m³, patented technology for highly integrated and simplified design
  • Batch/random/STAT mode available
  • Integrated control panel with machine, all consumable loading in real time
Innovative Design
  • Incubation, washing and detection all-in-one, detection efficiency improved
  • Using automatic intelligent control technology, low instrument failure rate
  • 100+ patented technologies, 100% self-developed
Compatible system
  • Compatible with AE/AP/HRP/ABEI CLIA assay protocol
  • Compatible with immunological reagents and instruments with different parameters and reaction modes

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Product category: Immuno assay testing

SARS-CoV-2 IVD Raw Materials

Aid the development and production of COVID-19 reagents and vaccines of IVD manufacturers
  • COVID-19 Disease Control & Diagnosis
  • Vaccines & Antibody Titer Tests
  • Epidemiological Surveys 
  • A series of products for SARS-CoV-2 and its mainstrain variants detection and differentiation
  1. COVID-19 Variant Strain Detection Raw Materials (Alpha, Beta, Delta)
  2. COVID-19 Neutralizing Antibody Test
  3. COVID-19 Antigen Test
  4. COVID-19 Antibody Test
  5. COVID-19 IgM & IgG Quality Control
  6. Secondary Antibody
  7. COVID-19 Nucleic Acid Test (RT-PCR Mix, Enzyme, High Throughput Sequencing, PCR Supplementary Material)

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Product category: Immuno assay testing

IVD Reagent Core Raw Materials Product Catalogue

Antigen, antibody and enzyme are key upstream raw materials of the IVD industry, and vital to determine the quality of IVD reagents. According to the nature indicated, Fapon Biotech's IVD reagents raw materials can be divided into core reaction system raw materials such as antigen, antibody, enzyme, and non-core reaction system raw materials such as substrate, quality control and calibrator.

1300+ Antigens, Antibodies, Enzymes
  • Immunoassay (ELISA / CLIA / CMIA)
  • Rapid Test (Immunofluorescence / Lateral Flow)
  • Biochemistry(Immunoturbidimetry / Latex-enhanced immunoturbidimetry)
  • Molecular Diagnosics (qPCR / NGS / Isothermal Amplification)

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Product category: Polymerase chain reaction (PCR)

P810 Real-time PCR Analyzer

Rapid Detection
  • 40 cycles within 10-15 min
  • Patented technology of ultra-fast heating and cooling
  • Patented technology of fast optical signal acquisition
 Robust Performance
  • Capillary tube enabling minimum reaction volume down to 10uL
  • Precise real-time temperature monitoring and feedback
  • Independent optical signal collection for each sample tube
Ease of Use
  •  Easy sample loading
  • Reliable and intelligent data analysis
  • Broad Application Scenarios

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Product category: Polymerase chain reaction (PCR)

iCatch 2000 Rapid Molecular Diagnostic System

Rapid Workflow:
  • the whole process can be finished within 20-30min
High Integration:
  • All the reagents are integrated in the cassette and tests can be processed by the system in a load-and-go manner.
Convenient Logics:
  • The cassette can be stored and transported at ambient temperature.
Easy Extension:
  • Various nucleic acid isolation solutions can be adopted for different specimens to render best performance.
Minimal Requirement:
  • The system can be operated by anyone at anywhere.
Multiplexity:
  • Nucleic acid solutions purified from the sample will be distributed into 4 PCR systems so that up to 12 targets can be analyzed in the sample.

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Product category: DNA testing

Fapon Biotech Raw Material Catalogue for Molecular Diagnostics

PCR Featured Materials Overview
  • HotStart PCR, qPCR
  • Hotstart PCR Mix
  • Whole Blood PCR Kit
  • Multi-PCR Enzyme Mix
  • Reverse Transcription PCR
  • One-Step RT-PCR Mix
  • Isothermal Amplification
NGS Featured Materials Overview
  • Enzyme Materials
  • Polymerase
  • Ligase
  • Exonuclease
Library Construction Preparation Module
  • DNA Library Construction
  • Library Amplification
  • Library Preparation Kit

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Company news

Date

Topic

19 Oct 2021

Fapon Biotech's Full Acquisition of Sequlite, Expands Its Strategic Presence in High-Throughput NGS

(DONGGUAN, China, Oct 18, 2021) -- Fapon Biotech Inc. (The Company or "Fapon Biotech") is pleased to announce its full acquisition of Sequlite Genomics ("Sequlite"), a USA enterprise that focuses on Next-Generation Sequencing (“NGS”). The two parties have signed a share purchase agreement online, with the Fapon Biotech team in Dongguan headquarter and Sequlite team in the USA. After the agreement, with a previous investment of 40% share in Sequlite, Fapon Biotech owns 100% Sequlite now. The Company takes over and manages Sequlite in all aspects of product research and development and business operation, further deepening its strategic presence in the global NGS business.

Sequlite specializes in the R&D of high-throughput NGS instruments and reagents. It has independently researched and developed core image processing algorithm (Base Calling software), core reagent raw materials production (such as high-fidelity DNA polymerase and high-purity nucleotide analogs), core optical imaging system adjustment and assembly process. It is worth mentioned that the Sequlite management team has deep genomics expertise from leading NGS companies.

Diligently worked in the IVD industry for over 20 years, Fapon Biotech has accumulated solid experience in product commercialization to serve its wide customer base. It has gained trust from more than 1,000 global business partners and achieved a relatively high market share in more than 40 countries. Fapon Biotech has always been a technology innovation driven company, with over 470 technology patents and 42% of the employees focused on R&D. About 28% of its sales revenue is invested in R&D annually. Along with the acquisition of Sequlite, the Company's R&D capability in the field of NGS will approach international top level and it will take a step further to build an R&D platform with global vision.

Meanwhile, the rising of another Chinese NGS instrument developer and manufacturer will accelerate the domestication of NGS platforms in China. In recent years, China's NGS market has developed rapidly. However, overseas brands have long dominated the core technologies and instruments. As a leading supplier of excellent IVD reagent raw materials and customized solutions in China, Fapon Biotech has worked in NGS business for several years, providing core raw materials for library prep kits and partnered with Sequlite team since its inception. In December 2020, Sequlite has completed the R&D phase and produced the functional prototype of SeqQ 100, an affordable NGS system (instrument, flow cells, and reagents) that provides flexible throughput and ease of use, which is highly desired in the clinical markets. More importantly, SeqQ 100 uses improved NGS technologies that are readily adoptable by customers worldwide, which allow them to keep their existing workflows.

The launch of the high-throughput NGS system has expanded Fapon Biotech's existing product catalog and marked an essential step of the Company’s vision to lead the establishment of open diagnostic ecosystem. Leveraging fully automatic CLIA (Short for Chemiluminescent immunoassay) analyzers, rapid MDx analyzers, and NGS systems, Fapon Biotech has fully covered immunoassay, molecular diagnostics, and NGS markets with these open system instrument platforms.

Millard Chan, the Co-founder and CEO of Sequlite, commented: "As Fapon Biotech is growing by leaps and bounds, I totally believe it has powerful strength in digging into cutting-edge diagnostic technology and providing one-stop solutions. Fapon Biotech has been a fantastic partner to Sequlite and we all look forward to a bright future where more people and organizations around the world may benefit from the power of NGS applied to healthcare.”

Mr. Zhiqiang He, the CEO of Fapon Biotech, echoed: "Both Fapon Biotech and Sequlite want to make better and more affordable NGS products. I hope that we can work together and remain true to our original aspiration to achieve this goal. NGS could be essential in the development of life science in the future and Fapon Biotech will continue to promote the development of early diagnosis and precision medicine in China and beyond, with our three different platforms of CLIA, MDx, and NGS."

Mr. Peng Cui, the Chairman of Fapon Group, said:" We are truly excited to welcome Sequlite to be a part of Fapon Family. This year marks Fapon's 20th anniversary. We have achieved some accomplishments in the past, but shall never stop pursuing our mission of "Improve Health and Enrich Lives."

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21 Jun 2021

The Pressing Need for Early Detection of Mucormycosis during COVID-19

Mucormycosis or black fungus, a devastating infection that soars in India during COVID-19 has seized global attention. Recently, the country's mucormycosis cases reached over 57,150 and resulted in 54% mortality. Apart from the association with high diabetes prevalence in India, COVID-19 infected countries (Pakistan, Russia, Nepal, Chile, Brazil, etc.) have also described the same issue, areas with high diabetes and COVID-19 infection rates should be alarmed.

Unfortunately, mucormycosis is always being diagnosed late with prolonged COVID-19 healthcare burdens that deteriorate the situation. As a company making continuous research and contribution to the world's major infectious diseases with the mission to Enable Disease Identification Earlier, More Accurate, Convenient and Affordable, Fapon Biotech Inc. (Fapon Biotech) calls for cooperation with academic and industry partners in developing mucormycosis diagnostic tests to ease the challenge by sharing the abilities of upstream raw material development platforms and downstream reagent application platforms.

Fapon Biotech is one of the mainstream COVID-19 reagent raw material suppliers with proven experiences helping partners to launch accredited COVID-19 reagents in a short time. The company has over 1000 IVD partners worldwide with more than 10 years of business operation in India. Its technology platforms can match the R&D process from partners easily and provide supports from biomarker discovery to commercialization. Through different application platforms of Fapon Biotech (Colloidal Gold/Immunofluorescence/ELISA/CLIA/Latex-Enhanced Immunoturbidimetry/PCR/etc.), biomarkers can quickly complete the process of application development. For partners encountering production challenges, OEM and contract manufacturing services with the capacity reaching hundreds of grams of each batch are available. Because of a strong relationship with laboratories and IVD manufacturers in India, cooperating with Fapon Biotech will have the access to more resources and commercial opportunities, such as clinical samples for research and product validation, technology iterations, product launch and promotion, etc.

As the virus continues its mutation and triggers diseases like mucormycosis to complicate the situation, rapid responses via global cooperation will be crucial for areas with overwhelmed healthcare burdens. Fapon Biotech is committed to fueling the advancement of COVID-19 diagnosis through collaborations with international IVD partners.

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19 Feb 2021

Fapon Biotech Introduces POCT Solution for COVID-19 E484K Mutation Testing

Fapon Biotech makes persist efforts to deal with the global pandemic new challenge, introduces COVID-19 Variant E484K POCT Solution for the effective differentiation of E484K and non-E484K infection. Previously, the company took a significant innovative step for being the first in the world in launching POCT Solution for variant B.1.1.7 (VUI 202012/01) and wild-type virus differentiation (https://bit.ly/3qDsmky). These solutions using POCT mechanism to offer additional values to the variant diagnosis using genome sequencing and PCR technologies, being an excellent mean to fight against the global-spread of mutant viruses.

New challenges in E484K and other mutant strains identification

The 'escape mutation' E484K that firstly found in 501Y.V2 (B.1.351) and 501Y.V3 (B.1.1.28) variant strains in the South African and Brazilian has now spread to UK, Mayotte, Belgium, France, Switzerland and other countries according to GISAID.

E484K is named 'an escape mutation' because it helps the virus bypass the body's immune defences and weakens the protective effect of some vaccines. In February, South Africa halt its rollout of the Oxford-AstraZeneca vaccine after a study showed "disappointing" results against the new variant. A study from Cambridge University has even confirmed the combination of more transmissible variant B.1.1.7 and E484K mutation substantially increases the amount of serum antibody needed to prevent infection of cells.

Moreover, the Manaus city in Brazil that thought to reach herd immunity in the first wave are now experiencing a second outbreak, and the situation is fuelling by the COVID-19 variants. However, only 0.03% of cases in Brazil underwent genomic sequencing for variant identification due to the lacking of resources.

The fight of COVID-19 is facing new challenges caused by complex variants and mutation. As a mainstream COVID-19 raw material supplier to the global top-profile reagent manufacturers, Fapon Biotech continues to keep a close watch on the ever-changing pandemic situation and introduce products for other mainstream strain identification.

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10 Aug 2020

Fapon 2nd COVID-19 Donation, 100 Million Anti-SARS-CoV-2 Fully Human RBD IgM & IgG QC Test Materials

Fapon Biotech Inc. (Fapon), a global leading IVD raw materials and one-stop solutions company, announces a new COVID-19 donation to meet the urgent demand for development and optimization of reliable quality controls for high-quality antibody tests by donating 100 million Anti-SARS-CoV-2 Fully Human RBD IgM & IgG QC test materials. The first donation initiated in February to provide 3 million PCR test components to solve the shortage of raw materials. The new charitable action will reinforce Fapon's corporate mission to Enable Earlier Disease Identification; More Convenient, Accurate and Affordable Diagnosis upon the fight of COVID-19.

The daily production of COVID-19 antibody tests is massive, as it is not only applied to assess infection but also other medical fields. However, news of false-negative test results has never stopped. Fapon RBD IgM & IgG QC materials can aid the development and optimization of reliable quality controls, ultimately improve antibody test performance and tackle the false-negative challenge.

"In this unprecedented time with continually changing medical needs, we are utterly resolute in bringing tangible, beneficial impacts on the industry by supporting partners with what they need now and next," stated by the CEO of Fapon.

"The industry's feedback on our first PCR donation was extraordinary. We alleviated the raw material shortage. PCR manufacturers over forty countries collaborated with us to develop and manufacture tests. We had supplied raw materials for the manufacturing of over 100 million diagnostic tests and ramped up the production capacity of 500%."

"This second donation offers high-demand QC materials that sit in the heart of reliable antibody tests. It will help to accelerate the internal QC process and achieve test result confidence. We strongly look forward to the participation of global IVD partners."

Fapon manifests unmatched R&D capabilities during the pandemic to bring new COVID-19 products continuously to the market. Featured products include N Antibodies, N/S/RBD Antigens, ACE2 Antigens, Secondary Antibodies, Direct One-Step RT-PCR Test Components, Enzymes and others. The full product list is available via https://bit.ly/2DxarJ1.

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About us

Company portrait

Fapon Biotech Inc. was founded in 2001. Guided by the mission of "Enable Disease Identification Earlier, More Accurate, Convenient and Affordable", the company focuses on the future needs and trends of biotechnology developments and provides global diagnostic companies with high-performance IVD reagent raw materials, such as antigens, antibodies, and enzymes, as well as one-stop solutions with instrument and reagent services.

With the profound insight into the healthcare trend that shifts from diseasing treating to disease-preventing, Fapon Biotech had built a comprehensive technology platform. Over 1,300 industrial-grade materials such as antibodies, antigens and enzymes were independently developed and launched, being widely applied in Rapid Test, ELISA, CLIA, CMIA, Biochemistry, Molecular Diagnostics, NGS, etc. One-stop solutions providing open instrument platforms and reagents were also introduced based on the in-depth understanding of industry trends to satisfy customers' needs in different application scenarios.

Fapon Biotech's products and services are highly integrated to promote synergic resources and shared values to the industry. Nowadays, the company has over 1000 partners around the world and is one of the very few Chinese IVD companies that have entered the high-end markets of developed countries in Europe, North America and Asia (Japan). Through continuous innovations in products and services, Fapon Biotech will make the developments of diagnostic technologies benefiting more people and advance the cause of human health.

Company data

Sales volume 200-499 Mio US $
Export content max. 50%
Number of employees 500-999
Foundation 2001
Area of business Imaging and diagnostics / medical equipment and devices