Aacc 2013 booth rev


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  • Cumitech (ASM) and CLSI vs. FDA, CAP and ISO have opposing definitions of verification and validation. The FDA/CAP definitions are present here.
  • Aacc 2013 booth rev

    1. 1. An industry leader and innovator in Infectious Disease Diagnostic Development, ZeptoMetrix Corporation (ZMC) is a fully integrated Biotechnology Company whose Products and Services support all phases of R&D, Assay Validation and Verification, Manufacturing, Regulatory Submissions and Test Kit Commercialization.
    2. 2. BUFFALO, NY Corporate Headquarters (Buffalo-Niagara Medical Campus) Research & Development 21,000 sq. ft. 2 large Biological Level 3 Plus Laboratories ISO 13485:2003 Certified CDC Select Agent License USDA Select Agent License FRANKLIN, MA FDA Registered Manufacturing Facility Distribution and Fulfillment Services, Biorepository 25,000 sq. ft. cGMP Compliant Manufacturing & Clinical Sample Repository cGMP Compliant Testing Laboratory ISO 13485:2003 Certified FDA Registered Blood Establishment FDA Establishment License IVD Controlled and Manufactured Product Facility
    3. 3. Research and Development Purified Microorganisms (Viruses, Bacteria, Fungii) and Derivatives (Sucrose Purified, Titered Culture Fluids, Lysates, Purified DNA/RNA) Serum Spiked Organisms for Regulatory Studies. Virology and Microbiology Service Laboratory, Infectivity Validations, Growth Studies, TCID50, Custom Projects Biorepository containing >1,000,000 samples (Disease State Samples, Normal Human Serum, Cancer Markers, Chemistries, AutoImmune, Pregnancy (1st, 2nd and 3rd Trimesters) Seroconversion Panels - HIV, HBV, HCV and EBV ELISA Kits - HIV p24 Ag, SIV, HTLV, Human, Mouse & Bovine IgG, IgM Western Blots - HIV, SIV, HTLV, I/II, Helico Blot 2.1 Infectious Disease Research Solutions
    4. 4. Manufacturing Bulk Disease State and Normal Human Plasma and Serum Dilutional Base Matricies for Serology, Antigen and Molecular based Assays (Natural and Synthetic) OEM Control and Calibrator Formulations (Serology or Molecular): Bulk or Finished Vials In Process and Final Product Release Panels Product Validation CLIA Validation Panels for Serology (SeroDetect) and Molecular Platforms (NATtrol™ ). Sensitivity/Specificity , Range Validation and Interfering Substance Panels NATtrol™ External Run Controls for Molecular Testing of Viral, Bacterial and Fungal Markers (Multiple Species and Concentrations) Rapid Test Controls for Serological and Antigen based Assays Infectious Disease Research Solutions
    5. 5. Regulatory Submissions Assay Validation and Verification Studies Laboratory Service Testing, Sensitivity/Specificity Test Kit Commercialization Marketing, Training, Proficiency and Reference Panel Development External Run Controls BioStor™ BioRepository and Fulfillment Services Infectious Disease Research Solutions
    6. 6. Additional ZeptoMetrix Product/Service Offerings Serological and PCR/NAT Controls and Calibrators Virology and Oxidative Stress Service Laboratory Testing Microorganisms and Derivatives Proficiency and Reference Panels Research Test Kits Test Kit Development and Validation Services Clinical Specimens and Repository Services
    7. 7. “Although Manufacturers may assist Laboratories by providing quality control instructions, the Laboratory is ultimately responsible for the performance of appropriate quality control procedures, including the documentation and interpretation of quality control data. Under subpart M, the Director is responsible for ensuring that quality control and quality assessment programs are established and maintained….” See: §493.1256(d) RESPONSIBILITYACCOUNTABILITYLIABILITY
    8. 8. Appropriate Frequency of QC Testing Required for Molecular Amplification Tests  Every Lab must run 2 levels of External QC Materials each day that it performs a nonwaived test  Amplification Tests are excluded from equivalent QC procedures*  i.e. 10 or 30 days of acceptable QC results with two levels of External Controls does not reduce the QC testing requirements * Brochure #4—Equivalent Quality Control Procedures (CLIA)
    9. 9. Acceptable Forms of External QC Materials*  Commercially Prepared Controls  In-House Prepared Controls  Reference or Controls Strains of Microorganisms  Multiple Calibrators of Separate Lot Numbers and Concentrations than those used to Calibrate the System  Previously Tested Patient Specimens provided the Laboratory determines the acceptable performance level for the patient specimens  Proficiency Testing Specimens for which the results have been confirmed  Labs should confirm that they are allowed to maintain PT samples. * §493.1256(c)
    10. 10. Standard: Control Procedures (c) The control procedures must— (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. * §493.1256(c)
    11. 11. CLIA requirements for External Run Controls  Need to be run at Regular Intervals (every Run, every Day or Weekly) based on the Assay Configuration  Two Levels of Challenge (Low and Medium Reactivity) are necessary  Formulation needs to be as close to a True Clinical Specimen as possible  Run with Same Testing Protocol as a Clinical Specimen  Commutability with Serum, Plasma and other Biological Fluids
    12. 12. Validation vs. Verification Validation • “confirmation, through the provision of objective evidence, that requirements for a specific intended use or application have been fulfilled” (ISO 9000) • validation determines that the correct test is being utilized Verification • “confirmation, through the provision of objective evidence, that specified requirements have been fulfilled” (ISO 9000) • verification determines that the test is being utilized correctly Arch Pathol Lab Med. 2009;133:743-755, Jennings, Van Deerlin and Gulley; CAP Molecular Pathology Resource Committee
    13. 13. CLIA Testing Requirements by Test Type LDT-(Home Brew) LDT-ASR Modified FDA-Cleared FDA-Cleared Risk Lab Testing Requirements High High LowLow
    14. 14. CLIA Verification of Analytical Performance Characteristics Verification Report When: Initial Setup and at Regular Intervals for assessment of technical variability: reagents, equipment, users, calibration, etc. Analytical Sensitivity (Positive Agreement) Analytical Specificity (Negative Agreement) Precision, day to day, user to user, instrument to instrument Interfering Substances: Matrix Effects, Clinical Specimens, Commutability CLSI EP12-A Qualitative Test Performance CLSI EP15-A2 Precision
    15. 15. Additional Requirements for Molecular Test Launch • Completed Verification Report • Written Assay Procedures • Written Reports and Forms • Training Checklist • Competency of Staff Documented • MSDS Forms on file • Billing and Testing Codes Established • Completed Training • Equipment Maintenance and Calibration Schedule • Enrollment in a Proficiency Program (CAP)
    16. 16. Background: HIV, HCV, HBV Bloodscreening External Run Controls Theory : Microorganisms require discrete Surface Protein Receptors to bind to and penetrate a host cell. Hypothesis: When we modify those Surface Proteins such that the Microorganism can no longer bind to a host cell, then the Microorganism should become noninfectious and… When we modify those Surface Proteins without damaging the inner Nucleic Acids, then the modified Microorganism should still function in a Molecular based Assay. Conclusion: Two highly controlled Biomedical Procedures are used to modify the Surface Proteins and render the Microorganism noninfectious. NATtrol™ Molecular Controls
    17. 17. Product Highlights: Non-Infectious Safe Purified Serum Protein Matrix Whole Intact Organism Works across all Platforms Mimics a true Clinical Specimen Contains the entire genome of the Microorganism, not Synthetic sequences of RNA Full Process Controls for all processes involved with Extraction & Amplification of the Microorganism Refrigerator Stable Simple storage and quick usage v. Frozen Requires 2 °C to 8 °C unlike most that demand-20 °C NATtrol™ Molecular Controls
    18. 18. Product Highlights: 1-2 year Stability Superior Shelf Life Longer Availability/Reuse Capabilities Flexible Availability Available as Individual or Multiplexed Controls Compatible Biotechnology Process is viable for Virus, Bacteria, Fungi, Parasite and Bacteriophage Organisms. Broad Patent Coverage Protected Technology NATtrol™ Molecular Controls (cont.)
    19. 19. Currently Available Viruses • Adenovirus • Banzi • BK • Bovine Leukemia • Bovine Viral Diarrhea (BVDV) • Chikungunya • Coronavirus • Coxsackievirus • Cytomegalovirus (CMV) • Dengue 1, 2, 3, 4 • Echovirus • Enterovirus • Epstein-Barr (EBV) • Hepatitis A (HAV) • Hepatitis B (HBV) • Hepatitis C (HCV) • Herpes Simplex (HSV 1, 2) • Human Herpes (HHV6, 7, 8) • Human Immunodeficiency (HIV) • Human Metapneumovirus (hMPV) • Human T-lymphotrophic (HTLV) • Ilheus • Influenza A • Influenza B • Measles • Minute Virus of Mice (MVM) • Mouse Hepatitis (MHV) • Mouse Mammary Tumor (MMTV) • Mumps • Parainfluenza • Parechovirus • Respiratory Syncytial (RSV) • Rhinovirus • Rotavirus • Rubella • Saint Louis Encephalitis (SLEV) • Severe Acute Respiratory Syndrome (SARS) • Simian Immunodeficiency (SIV) • Varicella Zoster (VZV) • West Nile (WNV) • Yellow Fever • Zika
    20. 20. Currently Available Bacteria, Fungi & Parasites • Acinetobacter • Aspergillus • Bacillus • Bacteroides • Bifidobacterium • Bordetella • Brucella • Burkholderia • Campylobacter • Candida • Chlamydia • Citrobacter • Clostridium • Corynebacterium • Cronobacter • Cryptococcus • Cunninghamella • Entamoeba • Enterobacter • Enterococcus • Escherichia • Francisella • Fusarium • Gardnerella • Haemophilus • Helicobacter • Klebsiella • Kocuria • Lactobacillus • Legionella • Listeria • Micrococcus • Moraxella • Mucor • Mycobacterium • Mycoplasma • Neisseria • Nocardia • Prevotella • Proteus • Pseudomonas • Rhizobium • Rhizopus • Rothia • Saccharomyces • Salmonella • Scedosporidium • Serratia • Shigella • Staphylococcus • Stenotrophomonas • Streptococcus • Toxoplasma • Tremella • Trichomonas • Vibrio • Yersinia
    21. 21. Recombinant Controls • Blastomyces dermatitidis, assay specific • Coccidioides immitis, assay specific • Coronavirus HKU, assay specific • Cryptosporidium parvum, assay specific and native organism control is in development • Cyclospora cayetanensis, assay specific recombinant in development • Escherichia coli, O157, assay specific • Giardia lamblia, assay specific and native organism control is in development • Histoplasma capsulatum, assay specific • Norovirus group I • Norovirus group II • Pneumocystis jiroveci, assay specific • Sapovirus, assay specific recombinant in development • stx1 and stx2, can be exported out of the US, assay specific • Vibrio cholerae, can be exported out of the US, assay specific
    22. 22. Recent ZeptoMetrix Highlights Select Agent Regulations Exemption SARS-CoV---Select Agent as of 12/4/2012. In February 2013 the Centers of Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) has determined and approved an exclusion for ZeptoMetrix Corporation’s NATtrol™-treated SARS-CoV Molecular Controls from the Select Agent Regulations, including those regarding the possession, use and transfer of select agents (42 C.F.R. 73 and 9 C.F.R. 121).
    23. 23. Recent ZeptoMetrix Highlights NATtrol™ RP Multimarker Control # NATRPC-BIO Designed to evaluate/monitor the performance of the FilmArray™ RP Assay Whole Intact Organisms Mimics true Clinical Specimens Contains the entire genome of each Microorganism Full Process Controls for all processes involved with Extraction & Amplification of the Microorganism Refrigerator Stable Not frozen Simple storage /quick usage Requires 2 °C to 8 °C storage Gel Pack v. Dry Ice Superior Stability Superior Shelf Life Longer Availability/Reuse Capabilities Bacterial Targets
    24. 24. Recent ZeptoMetrix Highlights NATtrol™ EBV Linearity Panel # NATEBV-LIN Whole Intact Organism Mimics a true Clinical Specimen Contains the entire genome of the viral particle Full Process Controls for all processes involved with Extraction & Amplification of the Microorganism Refrigerator Stable Not frozen Simple storage /quick usage Requires 2 °C to 8 °C storage Gel Pack v. Dry Ice Superior Stability Superior Shelf Life Longer Availability/Reuse Capabilities
    25. 25. Recent ZeptoMetrix Highlights NATtrol™ EBV External Run Controls # NATEBV-ERCL and NATEBV-ERCM Whole Intact Organism Mimics a true Clinical Specimen Contains the entire genome of the viral particle Full Process Controls for all processes involved with Extraction & Amplification of the microorganism Refrigerator Stable Not frozen Simple storage /quick usage Requires 2 °C to 8 °C storage Gel Pack v. Dry Ice Superior Stability Superior Shelf Life Longer Availability/Reuse Capabilities
    26. 26. MolecularTesting Luminex xTAG Molecular Test Control Panel RVP Pending Yes (NATRVP-1,2 & 3) Enterics Pending Pending Biofire FilmArray Test Control Panel Res. Panel Yes (NATRPC-BIO) Yes (NATRVP-IDI) Roche Light Cycler 2.0/480 Test Control Panel HSV 1/2 (NATHSV1-0001; NATHSV1-0002; NATHSV1-0003; NATHSV1-0004; NATHSV1-0005; NATHSV2-0001; NATHSV2-0002; NATHSV2-0003; NATHSV2-0004; NATHSV2-0005) Pending GenMark eSensor XT Test Control Panel Res. Panel Pending Yes (NATRVP-3) HCV Genotype Pending Pending BD ProbeTec Test Control Panel CT/NG Yes (NATCT(434)-ERCM and NATCT(D-UW3)-ERCM; NATNG-ERCM) Pending
    27. 27. MolecularTesting Roche Ampliprep - Taqman Test Control Panel HIV Yes (NATHIV1-ERCL; ERCM) Yes (NATHIV1-LIN) HBV Yes (NATHBV-0001; NATHBV-0002; NATHBV-0003; NATHBV-0006) Pending HCV Yes (NATHCV-0001; NATHCV-0002; NATHCV-0003; NATHCV-0004; NATHCV-0005) Pending CMV Yes (NATCMV-ERCL;ERCM) Yes (NATCMV-LIN) CT/NG Yes (NATCT(434)-ERCL;ERCM and NATCT(D-UW3)- ERCL;ERCM) Pending Cepheid Test Control Panel MRSA Yes (NATMRSA-6MC and NATMSSA-6MC) Yes (NATMRSA/SAP-C and NATMRSAP-C) VZV Yes (NATVZV-001, NATVZV-002, NATVZV-003, NATVZV-004, NATVZV-005) Pending CT/NG Yes (NATCT(434)-6MC and NATNG-6MC) Yes (NATCTNGP-C) GBS Yes (NATSAG-6MC) Pending FLU A/B Yes (NATFLUA/B-6MC and NATFLUAH1N1-6MC) Yes (NATFVP-C) C. diff Yes (CDI-6MC) Yes (NATCDIP-C)
    28. 28. MolecularTesting Meridian Illumigene Test Control Panel C. diff Yes (NATCDI (NAP1)-ERCL; ERCM) Pending GBS Yes (NATSAG-6MC) Pending Focus Simplexa Test Control Panel Flu A/B Yes (NATFLUAH1-ERCL;ERCM and NATFLUB-ERCL; ERCM) Pending H1N1 (2009) Yes (NATFLUAH1N1-ERCL;ERCM) Pending CMV Yes (NATCMV-ERCL;ERCM) Yes (NATCMV-LIN) C. diff Yes (NATCDI(NAP1)-ERCL;ERCM) Pending Nanosphere SP Test Control Panel Res. Panel Pending Yes (NATFVP-NNS) GP/BC Pending Yes (NATBC/GP-NNS) C. Diff Yes (NATCDI(NAP1)-ERCL; ERCM) Pending Siemens Versant 440 Test Control Panel HIV Yes (NATHIV1-ERCL; ERCM) Yes (NATHIV1-LIN) HCV Yes (NATHCV-0001; NATHCV-0002; NATHCV-0003; NATHCV-0004; NATHCV-0005) Pending
    29. 29. SerologicalTesting Abbott Architect Ortho eci Avidia Centaur (Siemens) Panel SeroDetect HIV-Ab SeroDetect HBsAg SeroDetect Anti-HBs SeroDetect Hbcore SeroDetect HCV SeroDetect HTLV SeroDetect HCV-Ab M
    30. 30. ZeptoMetrix Corporation 878 Main Street, Buffalo, NY 14202 716-882-0920 25 Kenwood Circle, Franklin, MA 02038 508-553-5800 Gregory R. Chiklis, Ph. D. President and Chief Operating Officer chiklis@zeptometrix.com Karuna Sharma, Ph. D. Senior Director & Chief Science Officer karuna_s@zeptometrix.com Peter Trabold, Ph. D., MBA Director, Business Development peter_t@zeptometrix.com Michael A. Hershfield Director, Sales & Marketing mhershfield@zeptometrix.com