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2015, PREPARED BY KYLE SUNG
MOLECULAR DIAGNOSTICS
MARKET ANALYSIS & PRODUCT OVERVIEW
CONTENTS
 Introduction
 Market Analysis
 SolMag aNAPs
 Target Market
 Competitions
WHAT IS MOLECULAR DIAGNOSTICS?
Detecting diseases through molecular level, Nucleic Acids (DNA, RNA)
WHY MOLECULAR DIAGNOSTICS??
• Extremely Sensitive
• Qualitative & Quantitative (qPCR)
• IVD market trend, fastest growing category
HOW TO EXTRACT NUCLEIC ACIDS?
 Manual Extractions  Automated Extractions
90%
10%
Manual
Automation
MOLECULAR DIAGNOSTIC MARKET
---A Rapid Growth Market of IVD
Rapidly Increasing of Molecular Market
Data source: DARK Daily Laboratory and Pathology News
Data source: Frost & Sullivan
• Economic downturn and saturation
• Unstable reimbursement regulations
• For developed countries
• Increasing infectious diseases
• Rising incidences of cancer
• Genetic disorders
• Blood screening
Year 2013-2019: CAGR: 11.1%
MOLECULAR DIAGNOSTIC MARKET
16%
15%
5%
64%
Fish
Real Time PCR
Microarray
PCR
• Dominant nature & acceptance
of PCR & Real Time PCR over
other technologies, represents
almost 80% of the molecular
diagnostic market.
Nucleotide:
ATP, CTP,TTP,GTP
Primers
Template DNA
The Polymerase Chain Reaction (PCR) is a technology in molecular
biology used to amplify a single copy or a few copies of a piece
of DNA across several orders of magnitude, generating thousands to
millions of copies of a particular DNA sequence.
POLYMERASE CHAIN REACTION (PCR)
PCR & REAL TIME PCR INSTRMENTS
The Infectious disease area represent 55% of the molecular diagnostics market
MDX INFECTIOUS DISEASE MARKET SHARE
Basic Factor of PCR &
other Molecular Analysis:
Extraction and Purification of
Nucleic Acids(DNA, RNA)
 Manual Extractions  Automated Extractions
INTRODUCING
SolMag aNAPs
(Automated Nucleic Acid Purification System)
PRODUCT INTRODUCTION
Automated Nucleic Acid Isolation Systems
®
INTENDED USE OF SOLMAG
®
Magnetic Bead Separation:
Bench-top automated system for quick purification of nucleic acids from bio-
specimens using magnetic bead separation technology.
Liquid Handling System:
Liquid handling automation, using pre-filled reagent cartridges
For research and in vitro diagnosis use
CORE TECHNOLOGIES
The Solis-Charger
®
Technology
The Solis-ChargerR Technology is a novel magnetic bead-based technology
that provides a switchable surface charge dependent on the pH and salt
concentration of the surrounding buffer to facilitate nucleic acid purification.
In low pH conditions, the magnetic beads have a positive charge that binds
the negatively charged nucleic acid backbone (see figure1 below). Proteins
and other contaminants are not bound and are simply washed away in an
aqueous wash buffer. To elute nucleic acids, the charge on the surface of the
bead is neutralized by raising the pH to 8.0 using a low salt elution buffer (see
figure below). Purified nucleic acid elutes instantly into this elution buffer, and
is ready for use in downstream applications.
SOLMAG
®
12 SPECIFICATION
Automated Nucleic Acid Purification System
SolMag
®
12:
 Compact Bench-top Instrument
 Process 1-12 samples simultaneously
 7 inches touch screen
 Light: Total weight less than 42 Kg
 Fast: Up to 12 results in 35 minutes
 Precise liquid volume and temperature control
 Extremely easy to operate and maintain
SolMag
®
24:
The SolMag®24 provides all the advantages of the
SolMag®12, and increases the throughput to 24
samples per run
SOLMAG
®
12 SPECIFICATIONS
Light as feather:
SolMag
®
12 weights only
42kgw, which is 50% lighter in
average than other similar
throughputs liquid handling
extractor in the market.
MagNaPure Compact: 60Kg
Qiagen EZ1 Advanced XL: 48Kg
MagCore HF16: 70Kg
SolMag
®
12
Part No. SVP0101
Dimensions (W x D x H) 637mm x 462mm x 540mm
Weight 42kgw
Interface 7” LCD touch-screen
Processing time 20 – 45mins
Throughput 1-12 Samples per run
Temperature
Uniformity
±0.5℃
Liquid Extraction
Volume Error
Less than 5%
Sample Volume 50ul – 3000ul
Elution Volume 30ul – 200ul
Power Input power :
90 ~ 132V&180 ~ 264Vby switch
50/60Hz
Out power :5V60A
Certification CE、IVD、FDA
UNIQUE SPECIFICATIONS
7” Touch Screen:
Optimized built-in protocol covers six major applications such as clinical
diagnostic, forensic science, food safety and CFC.
Built-in Template:
Up to three preferable
templates can be set up by
the users for performing the
same routine protocol
daily, which can also
reduce the risk from human
operational error.
SOLMAG ISOLATION KITS
Ready-to-use pre-filled, Reagent Cartridge:
The SolMag
®
Nucleic Acid Isolation kits contain all reagents and
disposables needed for 48 nucleic acid isolation reactions.
SolMag
®
NA Isolation Kits
1. Blood/Tissue Nucleic Acid Isolation Kit
2. Virus Nucleic Acid Isolation Kit
3. Pathogen Nucleic Acid Isolation Kit
4. Food Safety Nucleic Acid Isolation Kit
5. Forensic Science DNA Isolation Kit
6. Circulation Nucleic Acid Isolation Kit
7. Virus Nucleic Acid Isolation Kit - Large Volume
• Use of prefilled, film-sealed
reagent cartridges
• No manual adding chemicals
or reagent buffers required
• Auto piercing after the
purification protocol runs
INTEGRATED ADVANTAGES
 Reliable
 Advanced magnetic separation technology
 High collection rate of Magnetic particles (≥98%) and
sensitivity(≥98% of 100 copies/mL)
 High purity
 Consistent heating temperature: ≤1.5% well to well CV
 Efficient
 Short set up time.
 extract 24 specimens within 30~40 minutes
 User-friendly
 UV lamp, effective to avoid contamination
 Exceptionally stable & quiet during whole extraction
process.
 Human-friendly touch screen user interface
TARGET MARKETS
•Pregnant women: NIFTY
•Blood donators: Screening such as HBV, HCV
etc. from blood
Screening
•Cancer patients: Tumor target gene mutation
detect for drug use
•Infectious disease patients: Drug resistance
detection such as HBV YMDD mutation detect
Monitor
•Vaccine acceptors: Genotyping detection for
virus before vaccine injection, such as HPV.
•Patients with chronic kidney disease or liver
disease, HBV, HCV…: Blood test.
Prevention
•PCR for target gene accumulation
•Sequencing for mutation & methylation
analysis
•Further biological research such as
transcription, plasmid composing, RNAi etc.
Research
Hospital;
Blood stations
Pharmacies;
Dialysis center
Community
Health Centers ;
CDC
Biology Labs:
Academies
Research
Institutes
TARGET CUSTOMERS
Region:
• Undeveloped, Under-Developed Countries: High infectious diseases rate
(STD, HBV, HCV, HPV)
• Developed Countries: Gene Therapy, Sequencing (Micro Array, NGS)
Potential Customers:
• Hospital & CDC
• Basic biological
research
• Blood bank, DNA bank
• Forensic lab
• Food inspection lab
• GMO lab
COMPETITIONS- Magnetic Pillar/Rod System
Advantage
 Compact Size
 Relative low cost on instrument and kits
Disadvantage
 Easy to have magnetic bead residues in eluted products
 Limited or fixed sample/ elute volume handling choice
 No liquid handling system, extremely low flexibility for downstream
automated integration.
 Semi-Automation: tedious manual set up procedure required, kills time and
cause humor errors.
Ex:
 Maxwell (Promega)
 KingFisher (Thermo Fisher)
 Tan Beads (Taiwan)
 Vibrance (Acon, China)
 TianLong (China)
COMPETITIONS- Liquid Handling System
Advantage
 Fully walk away automation: Liquid Handling ensures the highest possible
automated integration. (NA extraction  PCR set up  PCR
detection, sample in to result out solution in future)
 Enable to handle a wide range of volumes on starting material.
 Extra manual steps during before or during extraction are not required.
Disadvantage
 Compare with Magnetic Pillar system, size of instrument is bigger and
heavier.
 Higher instrument cost
Ex:
 MagNa Pure Compact (Roche)
 EZ1 Advanced (Qiagen)
 iPrep (Invitrogen)
(All Manufactured by PSS, Japan)
 SOLMAG (SOLISON)
 MagCore (RBC)
COMPETITION COMPARISON
Instruments
Solison
(SolMag12)
Maxwell
(Promega)
Qiagen
Qia Symphony
MagNaPure
(Compact)
Mechanical Design Liquid Handling
Magnetic
Pillar/Rod
Working Station Liquid Handling
Open/Closed Platform Closed Open Closed Closed
Technology (magnetic and/or
silica/filtration (vacuum) extraction)
Magnetic beads Magnetic beads Magnetic beads Magnetic beads
Input specimen volume range,
min-max(ul)
50ul-3000ul 400ul 100-1000ul 200-400ul
Output volume, min-max(ul) 30-200ul N/A 20-150ul 60-200ul
Throughput 12 16 1-96 1-8
Estimated cost/ Instrument US$10,000 $17,000 US$50,000 US$30,000
Estimated cost/specimen $2.0 $5.5 $5.6 US$7
THANK YOU
FOR YOUR ATTENTION!!
Solison Biotechnology Corp.
Web: www.solisonbio.com
Add: No. 3-2, Chien-kuo road, TEPZ Tantzu, 427 Taichung, Taiwan R.O.C
Tel: +886 4 2531 1334
Fax: +886 2 2531 1343
Mail: info@solisonbio.com

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MDx Market Analysis & Product Overview

  • 1. 2015, PREPARED BY KYLE SUNG MOLECULAR DIAGNOSTICS MARKET ANALYSIS & PRODUCT OVERVIEW
  • 2. CONTENTS  Introduction  Market Analysis  SolMag aNAPs  Target Market  Competitions
  • 3. WHAT IS MOLECULAR DIAGNOSTICS? Detecting diseases through molecular level, Nucleic Acids (DNA, RNA)
  • 4. WHY MOLECULAR DIAGNOSTICS?? • Extremely Sensitive • Qualitative & Quantitative (qPCR) • IVD market trend, fastest growing category
  • 5. HOW TO EXTRACT NUCLEIC ACIDS?  Manual Extractions  Automated Extractions 90% 10% Manual Automation
  • 6. MOLECULAR DIAGNOSTIC MARKET ---A Rapid Growth Market of IVD Rapidly Increasing of Molecular Market Data source: DARK Daily Laboratory and Pathology News Data source: Frost & Sullivan • Economic downturn and saturation • Unstable reimbursement regulations • For developed countries • Increasing infectious diseases • Rising incidences of cancer • Genetic disorders • Blood screening Year 2013-2019: CAGR: 11.1%
  • 7. MOLECULAR DIAGNOSTIC MARKET 16% 15% 5% 64% Fish Real Time PCR Microarray PCR • Dominant nature & acceptance of PCR & Real Time PCR over other technologies, represents almost 80% of the molecular diagnostic market.
  • 8. Nucleotide: ATP, CTP,TTP,GTP Primers Template DNA The Polymerase Chain Reaction (PCR) is a technology in molecular biology used to amplify a single copy or a few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. POLYMERASE CHAIN REACTION (PCR)
  • 9. PCR & REAL TIME PCR INSTRMENTS
  • 10. The Infectious disease area represent 55% of the molecular diagnostics market MDX INFECTIOUS DISEASE MARKET SHARE
  • 11. Basic Factor of PCR & other Molecular Analysis: Extraction and Purification of Nucleic Acids(DNA, RNA)  Manual Extractions  Automated Extractions
  • 12. INTRODUCING SolMag aNAPs (Automated Nucleic Acid Purification System)
  • 13. PRODUCT INTRODUCTION Automated Nucleic Acid Isolation Systems ®
  • 14. INTENDED USE OF SOLMAG ® Magnetic Bead Separation: Bench-top automated system for quick purification of nucleic acids from bio- specimens using magnetic bead separation technology. Liquid Handling System: Liquid handling automation, using pre-filled reagent cartridges For research and in vitro diagnosis use
  • 15. CORE TECHNOLOGIES The Solis-Charger ® Technology The Solis-ChargerR Technology is a novel magnetic bead-based technology that provides a switchable surface charge dependent on the pH and salt concentration of the surrounding buffer to facilitate nucleic acid purification. In low pH conditions, the magnetic beads have a positive charge that binds the negatively charged nucleic acid backbone (see figure1 below). Proteins and other contaminants are not bound and are simply washed away in an aqueous wash buffer. To elute nucleic acids, the charge on the surface of the bead is neutralized by raising the pH to 8.0 using a low salt elution buffer (see figure below). Purified nucleic acid elutes instantly into this elution buffer, and is ready for use in downstream applications.
  • 16. SOLMAG ® 12 SPECIFICATION Automated Nucleic Acid Purification System SolMag ® 12:  Compact Bench-top Instrument  Process 1-12 samples simultaneously  7 inches touch screen  Light: Total weight less than 42 Kg  Fast: Up to 12 results in 35 minutes  Precise liquid volume and temperature control  Extremely easy to operate and maintain SolMag ® 24: The SolMag®24 provides all the advantages of the SolMag®12, and increases the throughput to 24 samples per run
  • 17. SOLMAG ® 12 SPECIFICATIONS Light as feather: SolMag ® 12 weights only 42kgw, which is 50% lighter in average than other similar throughputs liquid handling extractor in the market. MagNaPure Compact: 60Kg Qiagen EZ1 Advanced XL: 48Kg MagCore HF16: 70Kg SolMag ® 12 Part No. SVP0101 Dimensions (W x D x H) 637mm x 462mm x 540mm Weight 42kgw Interface 7” LCD touch-screen Processing time 20 – 45mins Throughput 1-12 Samples per run Temperature Uniformity ±0.5℃ Liquid Extraction Volume Error Less than 5% Sample Volume 50ul – 3000ul Elution Volume 30ul – 200ul Power Input power : 90 ~ 132V&180 ~ 264Vby switch 50/60Hz Out power :5V60A Certification CE、IVD、FDA
  • 18. UNIQUE SPECIFICATIONS 7” Touch Screen: Optimized built-in protocol covers six major applications such as clinical diagnostic, forensic science, food safety and CFC. Built-in Template: Up to three preferable templates can be set up by the users for performing the same routine protocol daily, which can also reduce the risk from human operational error.
  • 19. SOLMAG ISOLATION KITS Ready-to-use pre-filled, Reagent Cartridge: The SolMag ® Nucleic Acid Isolation kits contain all reagents and disposables needed for 48 nucleic acid isolation reactions. SolMag ® NA Isolation Kits 1. Blood/Tissue Nucleic Acid Isolation Kit 2. Virus Nucleic Acid Isolation Kit 3. Pathogen Nucleic Acid Isolation Kit 4. Food Safety Nucleic Acid Isolation Kit 5. Forensic Science DNA Isolation Kit 6. Circulation Nucleic Acid Isolation Kit 7. Virus Nucleic Acid Isolation Kit - Large Volume • Use of prefilled, film-sealed reagent cartridges • No manual adding chemicals or reagent buffers required • Auto piercing after the purification protocol runs
  • 20. INTEGRATED ADVANTAGES  Reliable  Advanced magnetic separation technology  High collection rate of Magnetic particles (≥98%) and sensitivity(≥98% of 100 copies/mL)  High purity  Consistent heating temperature: ≤1.5% well to well CV  Efficient  Short set up time.  extract 24 specimens within 30~40 minutes  User-friendly  UV lamp, effective to avoid contamination  Exceptionally stable & quiet during whole extraction process.  Human-friendly touch screen user interface
  • 21. TARGET MARKETS •Pregnant women: NIFTY •Blood donators: Screening such as HBV, HCV etc. from blood Screening •Cancer patients: Tumor target gene mutation detect for drug use •Infectious disease patients: Drug resistance detection such as HBV YMDD mutation detect Monitor •Vaccine acceptors: Genotyping detection for virus before vaccine injection, such as HPV. •Patients with chronic kidney disease or liver disease, HBV, HCV…: Blood test. Prevention •PCR for target gene accumulation •Sequencing for mutation & methylation analysis •Further biological research such as transcription, plasmid composing, RNAi etc. Research Hospital; Blood stations Pharmacies; Dialysis center Community Health Centers ; CDC Biology Labs: Academies Research Institutes
  • 22. TARGET CUSTOMERS Region: • Undeveloped, Under-Developed Countries: High infectious diseases rate (STD, HBV, HCV, HPV) • Developed Countries: Gene Therapy, Sequencing (Micro Array, NGS) Potential Customers: • Hospital & CDC • Basic biological research • Blood bank, DNA bank • Forensic lab • Food inspection lab • GMO lab
  • 23. COMPETITIONS- Magnetic Pillar/Rod System Advantage  Compact Size  Relative low cost on instrument and kits Disadvantage  Easy to have magnetic bead residues in eluted products  Limited or fixed sample/ elute volume handling choice  No liquid handling system, extremely low flexibility for downstream automated integration.  Semi-Automation: tedious manual set up procedure required, kills time and cause humor errors. Ex:  Maxwell (Promega)  KingFisher (Thermo Fisher)  Tan Beads (Taiwan)  Vibrance (Acon, China)  TianLong (China)
  • 24. COMPETITIONS- Liquid Handling System Advantage  Fully walk away automation: Liquid Handling ensures the highest possible automated integration. (NA extraction  PCR set up  PCR detection, sample in to result out solution in future)  Enable to handle a wide range of volumes on starting material.  Extra manual steps during before or during extraction are not required. Disadvantage  Compare with Magnetic Pillar system, size of instrument is bigger and heavier.  Higher instrument cost Ex:  MagNa Pure Compact (Roche)  EZ1 Advanced (Qiagen)  iPrep (Invitrogen) (All Manufactured by PSS, Japan)  SOLMAG (SOLISON)  MagCore (RBC)
  • 25. COMPETITION COMPARISON Instruments Solison (SolMag12) Maxwell (Promega) Qiagen Qia Symphony MagNaPure (Compact) Mechanical Design Liquid Handling Magnetic Pillar/Rod Working Station Liquid Handling Open/Closed Platform Closed Open Closed Closed Technology (magnetic and/or silica/filtration (vacuum) extraction) Magnetic beads Magnetic beads Magnetic beads Magnetic beads Input specimen volume range, min-max(ul) 50ul-3000ul 400ul 100-1000ul 200-400ul Output volume, min-max(ul) 30-200ul N/A 20-150ul 60-200ul Throughput 12 16 1-96 1-8 Estimated cost/ Instrument US$10,000 $17,000 US$50,000 US$30,000 Estimated cost/specimen $2.0 $5.5 $5.6 US$7
  • 26. THANK YOU FOR YOUR ATTENTION!! Solison Biotechnology Corp. Web: www.solisonbio.com Add: No. 3-2, Chien-kuo road, TEPZ Tantzu, 427 Taichung, Taiwan R.O.C Tel: +886 4 2531 1334 Fax: +886 2 2531 1343 Mail: info@solisonbio.com