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ReaMetrix Overview

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ReaMetrix Overview Presentation

ReaMetrix Overview Presentation

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  • 1. ReaMetrix An Introduction
  • 2. Vision
    • ReaMetrix is committed to become a leading supplier of high quality and affordable integrated diagnostic solutions to resource poor settings, by leveraging local resources innovatively.
  • 3. ReaMetrix at a glance
    • Life science technology company founded in May, 2003, CEO - Dr. Bala Manian, Founder of many life science companies
    • Strong management team with global experience in process and product development in regulated environments.
    • Started in San Carlos, CA with the centre of activity in Bangalore, India.
    • State of the art lab and production facility in Bangalore India.
    • Strong team, 42 employees, 38 in India, 15 with PhD’s.
    • ISO 9001:2000 Certified in May 2008
    SAN CARLOS (HEAD OFFICE) BANGALORE (MANUFACTURING & R&D FACILITY) SINGAPORE (REPRESENTATIVE OFFICE)
  • 4.
    • Expertise in
    • Gene design
    • Cloning
    • Expression
    • Amplification & sequencing
    • Expertise in
    • Tailoring assays to hardware platform
    • Cell based and Bead based assays
    • ELISA, FLISA
    • From Proof of Concept to supply of assay kits
    • Expertise in
    • Labeling of proteins and nucleic acids with
    • Organic dyes
    • Phycobiliproteins
    • Nanocrystals
    • Expertise in
    • Optics based instrumentation and detection systems.
    • Integrated solutions with reagents to solve life science problems
    Assay Development Stable Cell Lines Custom Conjugations Instrumentation ReaMetrix Competencies Core competencies drive Diagnostics & Research businesses
  • 5. State of the art Indian Facility
  • 6. Driving Value Through Innovation The ReaMetrix Experience PE TR Cy5 Cy5.5 Cy7
  • 7. Immunofluorescent Conjugates
    • Identifying bright & affordable fluorophores
    • Optimizing process chemistry to generate high performance conjugates
    Innovation in design and process
  • 8. Identifying Alternate Dyes – Developing a Palette
    • Phycoerythrin and the range of dyes in the red region
    • PE emits at 562 nm
    • Texas Red or equivalents emit at 610 nm
    • Cy5,Dy649, Hilyte647 emit at 670 nm
    • Cy5.5, Hilyte680, Dy680 emit at 700 nm
    • Cy7 or Hilyte750, Dy750 emit at 770 nm
    PE TR Cy5 Cy5.5 Cy7
    • Allophycocyanin and the range of dyes in the red region
    • APC emits at 660 nm
    • Cy5.5 or equivalents emit at 700 nm
    • Alexa700 or LiCor700 emit at 720 nm
    • Cy7 or Hilyte750, Dy750 emit at 770 nm
    • Licor800 or equivalents emit at 800 nm
    APC Cy5.5 A700 Cy7 Licor800 High Quality Fluorescent Dyes at Affordable Cost
  • 9. Developing Immunofluorescent Conjugates
    • Optimize yields for fluorescent conjugations using process chemistry
    Incoming Quality Control Acquire unlabeled antibodies & other reagents from third parties Component purification Functional validation Unitizing and packaging Deliver finished product to customer Specification/ Quality Assurance Purification Process quality control testing Conjugation Process is our Product
  • 10. Key features of ReaMetrix conjugates
    • Site Specific Labeling of Antibodies with precise Dye to Protein ratios
    • High-quality (certificate of analysis provided for each product with all the requisite specifications)
      • Validated for fluorescence intensity, activity, protein & dye concentration, dye integrity, emission spectra
      • Perform functional validation where required
    • Audit trail (each and every step is documented to enable a high degree of transparency)
    • Selected Customers who have validated ReaMetrix Conjugates
      • Harvard University,
      • Duke University,
      • National Institute of the Health, USA,
      • Applied Biosystems
      • Tata Memorial Hospital
  • 11. Development conjugates for Leukemia-Lymphoma
    • Developed with 3 colors so that it can be used in India where 3 to 4 color Flow cytometers are prevalent.
    • Conjugates have been validated on peripheral blood/bone-marrow samples or stable cell lines with receptors.
    • The performance of these conjugates has been benchmarked with existing commercially available conjugates
    • ReaMetrix Conjugates can be provided at smaller unit sizes so that they are affordable and accessible to more testing centers
  • 12. Products Developed at ReaMetrix
    • Reagents for enumerating CD3+CD4+ reagents
      • TriTStat CD3/CD4/CD8
      • TriTStat CD3/CD4/CD45
      • ReaPan 34845
      • ReaTcount
    • ReaPan B27 – Reagent for typing HLA B27
    • ReaPan S34 – Reagent for enumerating CD34+ Hematpoietic stem cells
    Value addition through Innovation
  • 13. Typical Characteristics of ReaMetrix Products
    • Antibodies used are workshop approved clones
    • Fluorescent labels used have no intellectual property entanglements.
    • The assay protocols associated with these tests are similar to commercially existing assays
    • The major difference is that ReaMetrix reagents are delivered in a unitized dry format.
    • Particularly in resource poor settings, the dry reagent format reduces the cost of performing the assay and opens up additional options for providing access to the test for the patients.
  • 14. Reagent for monitoring HIV progression through the Enumeration of CD3+CD4+ Cells
    • TriTStat CD3/4/8 and CD3/4/45
      • MAH CD4 antibody labeled w/ Atto 488 dye (FITC alternative)
      • MAH CD8 antibody (or MAH CD45) antibody labeled with R-Phycoerythrin (PE)
      • MAH CD3 antibody labeled w/ PE-Dyomics 649 (Cy5 alternative) tandem dye
      • Precise number of fluorescent beads
      • Stabilizers
    • Tests are suitable to run on open flow cytometers such as BD FACScan, BD FACSCalibur, Coulter EPICS etc .
    • Reagents validated at
      • YRG care, Chennai
      • NARI, Pune
    • TriTStat CD3/4/8 is CE marked
    • Now available as a Four color reagent as ReaPan 34845
    • Reagent supplied in Dry, Unitized Format
    • No cold chain
    • Up to 5 day stability of stained-fixed samples
    CD4 0 300 600 900 1200 1500 0 300 600 900 1200 1500 Rmx Dry T-STAT Coulter TetraChrome r = 0.994
  • 15. ReaTcount – Affordable Alternative to FACScount ™
    • Reagent Supplied in a Dry, Unitized Format
    • Reagent validated at
      • National HIV Immunology Laboratory, Canada
      • Zimbabwe
    Excellent Correlation
  • 16. ReaPan B27 – For typing HLA B27
    • Use 2 clones – enhances sensitivity and specificity
    • Selection of CD3+ population to reduce false positives
    • Choice of PE as the dye to identify the HLA B27 population – High fluorescence
    • Addition of unconjugated Anti B7 antibody reduces nonspecific binding
    • Provision of Fluorescence Intensity beads in each reagent tube provides a built-in quality/reference standard
    • Dry Unitized Format
    • Simplified work flow
  • 17. ReaPan S34 – For Enumerating CD34 cells
    • Convenience: Dry, unitized ready to test format.
    • Single platform enumeration using Modified ISHAGE guidelines.
    • Stability: Dried down reagent does not require Cold Chain Maintenance.
    • Workflow: Simple accurate and repeatable Lyse no wash protocol.
    • Differentiates viable CD34+ stem cells from Non Viable(7-AAD).
    • Single step pipetting : Minimizes errors.
  • 18. New Product Ideas Under development in our labs
  • 19. ReaPanMicro – Presence/Absence Test for Bacteria in Urine
    • A diagnostic test to confirm the absence of bacteria in urine, based on the principle of nucleic acid detection in bacteria.
    • Key Features of the Test
      • High sensitivity ( 100% Negative Predictive Value )
      • Time to Result: Within 15 min of sample reaching a flow cytometer
      • Easy to use, simple assay workflow
    Culture Negative Culture Positive 146 Samples By Culture 67 22 TN 100.0% NPV 72.2% PPV 0 Negative by Flow 57 Positive by Flow TP Overall
  • 20. Bacteria Speciation Using Fluorescent Tags
    • Using Bacteriophages to detect bacteria
      • A: Bright field image of S.aureus bacteria stained with tag protein
      • B : Fluorescence image of stained S. aureus bacteria stained with tag protein
      • C: Bright field image of E. coli bacteria that was incubated with tag protein
      • D: Fluorescence image of E. coli bacteria that was incubated with tag protein
    A B C D
  • 21. Products under development - Controls
    • Positive Control Wells for Malaria
      • In collaboration with Foundation for Innovation in Diagnostics (FIND).
      • To develop as a positive controls that will validate the efficacy of Rapid Diagnostic tests for Malaria
    • Blood Controls
      • To develop blood controls for use in flow cytometry
    http://www.finddiagnostics.org/news/newsletters/issue_10-jun_08/page03.shtml Dot plots of 20 day stabilized blood samples
  • 22. Products under development
    • ReaPan Leuco – To enumerate Leukocytes in Leukoreduced Platelets
      • For rare event detection and enumeration of leukocytes
    • HbA1C
      • An affordable method for %HbA1C using immunofluorescence
    • Viral vs Bacterial Pyrexia
      • Differentiating between Viral and Bacterial Fever
    Leukocytes Beads
  • 23. Products under development
    • ReaPan CD61/41 – For the enumeration of platelets using immunofluorescent staining
      • For use in cases of Thrombocytopenia where existing enumeration methods do not work
    • ReaPan Mono – To enumerate Monocytes in peripheral blood.
  • 24. ReaDev Extending Innovations to Partners
  • 25. Stable Cell Line Development
    • Example of GPCR expressing cell lines developed at ReaMetrix
    Stable CHOKI cells expressing IL8RB stained with fluorescently labeled chemokine IL8
  • 26. Bead Based Assay Development for US biotechnology Company
    • Develop Sandwich Bead Based assay for three different antigens with lower detection limits of 0.5 ng/mL
    • Transfer assay protocol with prototype kits (100 to 1000 tests/assay)
    • Working assay format with antibody coated carboxy beads and detection through Biotinylated Ab.SAV-PE successfully developed at desired detection limits
    • Delivered complete Antigen Detection Assay kits with detailed report including assay protocols
    Antibody Screening
    • Screened various commercially available antibodies (Ab) against analyte for best Kd
    • Screened Antibodies in pairs to identify the pair with best detection sensitivity
    • Developed a bead based assay for the chosen analyte
    • Capture Ab on carboxy microsphere bead
    • Biotinylate detection Ab.
    • Tertiary Detection Through SAV-PE
    Bead Based Assay Format Antibody Pair Selection Assay Development R E A M E T R I X P R O C E S S Project Deliverables
  • 27. Expression of cardiovascular protein for MAb development for US Healthcare Company
    • Develop protocol for protein expression in mammalian cells.
    • The protein is to be used for MAb development
    • Delivered purified protein at 1 mg/L expression level on optimized cell line
    • Protein expression and purification in native conformation without tags
    Expression
    • Site directed mutagenesis
    • Cloning into SK+ vector
    • Sub-cloning into expression vectors
    • Sequencing to confirm the clone
    • Transfection and expression in three mammalian cell lines: CHO K1, COS 7, HEK 293
    • Affinity chromatography
    • Anion exchange chromatography
    • Gel Filtration
    • Characterization
    • SDS Page for Purity, Western Blot Analysis for Specificity, ELISA for quantitation
    Transfection Protein Purification & Characterization R E A M E T R I X P R O C E S S Project Deliverables
    • Optimized
    • Promoter/cell combination
    • DNA quantity per cell
    • Lipid to DNA ratio
    • Transfection time
    Lipids DNA Lipid complex Cloned DNA Secreted Protein
  • 28. Towards Affordable Diagnostics ReaMetrix Approach
  • 29. Clinical Information Generation – Current Scenario Sample journey and cost accumulation Acquire Process Run Provide Results Transport Collection centre Path Lab Doctor Hospital Centralized Path Lab Syringe/Vacutainer/Overheads Cold chain/Courier Tech Labor + Reagent Capital Equipment Amortization Lab Infrastructure Overheads
    • CD4 test example:
      • ~10 to 20 times cost addition from reagent manufacture to cost to patient
    • Average cycle time for results ~ 48 to 72 hours
    Layers of margin at every step
  • 30. Issues with the current scenario
    • Technical
      • Aged blood samples; accuracy & reliability of results
      • Time lag for treatment decisions
      • Lack of a patient centric approach
      • Imported equipment not designed for Indian environment. Eg. Automation, sample aggregation….
    • Commercial
      • Encourages too many layers of margin affecting affordability
      • Capital costs for imported equipment act as big barrier to entry as well as in adoption of closer to customer models
    • Social
      • Absence of Economic value-add at the local level
    Local economic activity needs to be promoted for enhanced reach of diagnostics
  • 31. What is the ReaMetrix Solution?
    • Total systems approach – in development
      • Instrument designed for local context  robust & affordable.
      • Reagents developed to suit local conditions  temperature & humidity.
      • Process improvement leveraging local talent  Reducing the cost of the consumable kits.
      • Alternate business/distribution models enabling local empowerment .
    • From a clinical standpoint:
      • Affordability enables more frequent testing & facilitates a more patient-centric approach.
      • Accessibility facilitates rapid transmittal of information at the local level.
    The ReaScan System – A Total Systems Offering
  • 32. ReaScan – In Development
  • 33. Summary
    • ReaMetrix is a platform for implementing innovative solutions to address the diagnostic needs of India
    • ReaMetrix is keen to work with partners who share a similar philosophy to create new solution opportunities
  • 34. Manufactured by ReaMetrix India Pvt. Ltd. 50-B, II Phase, Peenya Industrial Area Peenya, Bangalore 560058, India Ph: +91-80-28378693/5, Fax: +91-80-41172451 E-mail: info@reametrix.com www.reametrix.com Further details:

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