ReaMetrix An Introduction
Vision <ul><li>ReaMetrix is committed to become a leading supplier of high quality and affordable integrated diagnostic so...
ReaMetrix at a glance <ul><li>Life science technology company founded in May, 2003, CEO - Dr. Bala Manian, Founder of many...
<ul><li>Expertise in  </li></ul><ul><li>Gene design </li></ul><ul><li>Cloning </li></ul><ul><li>Expression </li></ul><ul><...
State of  the art Indian Facility
Driving Value Through Innovation The ReaMetrix Experience PE TR Cy5 Cy5.5 Cy7
Immunofluorescent Conjugates <ul><li>Identifying bright & affordable fluorophores </li></ul><ul><li>Optimizing process che...
Identifying Alternate Dyes – Developing a Palette <ul><li>Phycoerythrin and the range of dyes in the red region </li></ul>...
Developing Immunofluorescent Conjugates <ul><li>Optimize yields for fluorescent conjugations using process chemistry </li>...
Key features of ReaMetrix conjugates <ul><li>Site Specific Labeling of Antibodies with precise Dye to Protein ratios </li>...
Development conjugates for Leukemia-Lymphoma <ul><li>Developed with 3 colors so that it can be used in India where 3 to 4 ...
Products Developed at ReaMetrix <ul><li>Reagents for enumerating CD3+CD4+ reagents </li></ul><ul><ul><li>TriTStat CD3/CD4/...
Typical Characteristics of ReaMetrix Products <ul><li>Antibodies used are workshop approved clones </li></ul><ul><li>Fluor...
Reagent for monitoring HIV progression through the Enumeration of CD3+CD4+ Cells <ul><li>TriTStat CD3/4/8 and CD3/4/45 </l...
ReaTcount – Affordable Alternative to FACScount ™ <ul><li>Reagent Supplied in a  Dry, Unitized Format </li></ul><ul><li>Re...
ReaPan B27 – For typing HLA B27 <ul><li>Use 2 clones – enhances  sensitivity and specificity </li></ul><ul><li>Selection o...
ReaPan S34 – For Enumerating CD34 cells <ul><li>Convenience:  Dry, unitized ready to test format. </li></ul><ul><li>Single...
New Product Ideas Under development in our labs
ReaPanMicro – Presence/Absence Test for Bacteria in Urine <ul><li>A diagnostic test to  confirm  the absence of bacteria i...
Bacteria Speciation Using Fluorescent Tags <ul><li>Using Bacteriophages to detect bacteria </li></ul><ul><ul><li>A:  Brigh...
Products under development - Controls <ul><li>Positive Control Wells for Malaria </li></ul><ul><ul><li>In collaboration wi...
Products under development <ul><li>ReaPan Leuco  – To enumerate Leukocytes in Leukoreduced Platelets </li></ul><ul><ul><li...
Products under development <ul><li>ReaPan CD61/41  – For the enumeration of platelets using immunofluorescent staining  </...
ReaDev  Extending Innovations to Partners
Stable Cell Line Development <ul><li>Example of GPCR expressing cell lines developed at ReaMetrix </li></ul>Stable CHOKI c...
Bead Based Assay Development for  US biotechnology Company <ul><li>Develop Sandwich Bead Based assay for three different  ...
Expression of cardiovascular protein for MAb development for US Healthcare Company <ul><li>Develop protocol for protein ex...
Towards Affordable Diagnostics ReaMetrix Approach
Clinical Information Generation – Current Scenario Sample journey and cost accumulation Acquire Process Run  Provide  Resu...
Issues with the current scenario <ul><li>Technical  </li></ul><ul><ul><li>Aged blood samples; accuracy & reliability of re...
What is the ReaMetrix Solution? <ul><li>Total systems approach – in development </li></ul><ul><ul><li>Instrument designed ...
ReaScan – In Development
Summary <ul><li>ReaMetrix is a platform for implementing innovative solutions to address the diagnostic needs of India </l...
Manufactured by ReaMetrix India Pvt. Ltd. 50-B, II Phase, Peenya Industrial Area Peenya, Bangalore 560058, India Ph: +91-8...
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ReaMetrix Overview

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ReaMetrix Overview

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