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Products for Molecular Pathology Slide 2 An Overview History of BioSB Our Mission Key Personnel Product Lineup Markets Marketing Slide 3 Our Mission Our mission is to... Develop high-quality immunochemicals and technology for molecular pathology Provide outstanding customer and technical service to our customers Manufacture and develop FDA certified IVD products Excel in the development and marketing of unique products for immunopathology, Liquid Cytology, CISH/FISH and PCR. Provide biomedical laboratories with the tools to improve the diagnosis, prognosis and therapies that benefit patients worldwide Slide 4 Milestones 1998 - BioSB Founded by Dr. Alfonso Heras 1999 - BioSB Incorporated on May 11th 2005 - IHC Reagent Development 2005 - IHC Cell Line Development 2006 - Maxim Partnership (PCR) 2009 - ZytoVision Partnership (CISH/FISH) 2010 - FDA cGMP Certification 2010 -ZJ Shanghai Biotech (Real Time PCR) 2011 - OEM Equipment for Liquid Cytology 2012 - AmoyDx Partnership (PCR for Gene Mutations) 2012 - IHC Automation partnership with Thermo-Fisher 2013 ISO 13485:2003 Certification Slide 5 Key Personnel Slide 6 Product Lineup Slide 7 IHC Products IHC antibodies Manufactured in an FDA cGMP 820 and ISO13485:2003 certified facility High quality antibodies Competitive prices On average, between 20-30% less than competitor reagents Excellent customer service Catalog of antibodies consistently expanding Figure 1.1 Rabbit Monoclonal Antibodies from BioSB Slide 8 IHC Products Rabbit Monoclonal AB s Proprietary trans-hybriodoma technology for RMAb s (RBT Clones) Detection Systems/Ancillaries Proprietary technologies for manufacturing biotin-streptavidin HRP&AP IHC Detection Systems Polymeric detection systems (PolyDetector HRP/AP) Substrate chromogens & Ancillaries Complete PolyDetector kits for HPV, Her2-Nu, ER/PR, and CD117. Figure 1.1 Rabbit Monoclonal Antibodies from BioSB Slide 9 Cytology Figure 2.2 HPV Pap Smear Figure 2.3 HSIL Pap Smear Figure 2.1 Proprietary Liquid Cytology and ICC Kits; CytoDetector and CervicoDetector Figure 2.4 Normal Pap Smear Slide 10 ImmunoCytochemistry Figure 3.1 Bio SB Immunocytochemistry Mechanism of Action Figure 3.2 Proprietary Liquid Cytology and ICC Kits; CytoDetector and CervicoDetector Slide 11 CervicoDetector Figure 4.1 BioSB CervicoDetector Mechanism of Action Figure 4.2 IHC of P16 on HSIL Figure 4.3 IHC of ProEx on HSIL Figure 4.4 IHC of CervicoDetector on HSIL ImmunoCytochemistry Slide 12 Equipment & Slides Slide 13 BioSB TintoStainer BioSB TintoDetector TintoDetector Slide Holder Electric Pressure Cooker CytoLayer Press CytoLayer LX Centrifuge CytoLayer Vortex VX Automated Nucleic Acid Extraction Hydrophilic Plus Slides Equipment & Slides Slide 14 Equipment TintoDetector Slide Holder (Patent Pending) Creates capillary gap with regular slides Cost Efficient only 50 ul of reagent needed per slide Capillary Gap Based Used for CISH/FISH/ICC/IH C Slide 15 Equipment TintoDetector Designed for easy handling of slides for CISH/FISH/IHC/ICC Semi-Automated system Future incubator to have pressure cooking capabilities for tissue permeabilization Slide 16 Equipment TintoStainer 36 Slide Automated ICC/IHC System Barcode tracking and labelling for reagents and slides Custom protocol programming Works with biotin or polymer based detection systems Open systemuse any reagent or antibody Collaboration with ThermoFisher Scientific Slide 17 Hydrophilic Plus Slides Prevent Tissue Detachment Superior to competing slides Allows reagents to spread over entire slide Figure 5.1 Row 1 Hydrophilic Plus Slides Row 2 - Probe on Plus Slides Row 3 Untreated Slides Figure 5.2 Hydrophobic versus Hydrophilic slide Tissue Detachment Slide 18 Hydrophilic Plus Slides Figure 6.1 Hydrophobic versus Hydrophilic slide Tissue Detachment Slide 19 CISH/FISH CISH vs FISH Detect and localize DNA /RNA Probes Predictive value for target therapies (ex. Herceptin, Tyrosinase- kinase inhibitors etc.) Fig. 7.1 Her2 Positivity using CISH on Breast Tissue Fig. 7.2 Her2 Positivity using FISH on Breast Tissue Slide 20 FISH Time: 12-16 hours Observe signal with fluorescence microscopy Great Signal Temporary signal CISH/FISH CISH Time: 15-19 hours Observe tissue morphology and signal with optical microscopy Good Signal Permanent signal Slide 21 CISH/FISH Slide 22 Partnership FISH/CISH Slide 23 FISH Top Sellers ZytoLight SPEC HER2/CEN17 Dual Color Probe ZytoLight SPEC EGFR/CEN 7 Dual Color Probe New Products ZytoLight ALK/ELM4 Tricheck ZytoLight SPEC p16/CEN 3/7/17 Quadruple Color Probe (equivalent to UroVysion) *Information care of ZytoVision source: ZytoVision.com Figure 7.3 ZytoLight Mechanism of Action Slide 24 SPEC HER2/CEN17 Dual Color Probe FISH *Information care of ZytoVision source: ZytoVision.com Figure 8.1 Zytolight Kit for HER2/CEN17 Figure 8.2 Normal Breast Cells Figure 8.3 HER2 Amplified Breast Carcinoma FISH Slide 25 *Information care of ZytoVision source: ZytoVision.com SPEC ALK/ELM4 TriCheck Figure 9.1 Zytolight Kit for Alk/ELM4 Tricheck Figure 9.2 Chromosome 2 Figure 9.3 ALK Map Figure 9.4 ELM4 Map Slide 26 FISH SPEC ALK/ELM4 TriCheck Figure 10.1 ALK/ELM4 Mechanism of Action Figure 10.3 Cells with EML4-ALK Inversion Figure 10.2 Normal cells (No- rearrangement) Slide 27 CISH Top Sellers ZytoDot SPEC HER2 Probe Kit ZytoDot CEN17 Probe ZytoDot 2C SPEC HER2/CEN17 Probe Kit New Products ZytoDot ALK/ELM4 Probe Figure 11.1 ZytoDot Mechanism of Action Figure 11.2 ZytoDot 2C Mechanism of Action Slide 28 CISH *Information care of ZytoVision source: ZytoVision.com Figure 12.1 ZytoDot HER2 Kit Figure 12.3 Breast Cancer Tissue HER2 Amplified Figure 12.2 Map of HER2 on Chromosome 17 SPEC HER2 Probe Slide 29 CISH *Information care of ZytoVision source: ZytoVision.com 2C SPEC HER2/CEN17 Probe Kit Figure 13.1 ZytoDot 2C SPEC HER2/CEN17 Kit Figure 13.2 & 13.3 Tissue Probed with HER2/CEN17 Kit Green = HER2 Red = CEN17 Slide 30 CISH *Information care of ZytoVision source: ZytoVision.com 2C SPEC ALK/ELM4 Break Apart Kit Slide 31 *Information care of ZytoVision source: ZytoVision.com Figure 14.3 Lung Carcinoma probed with ZytoVision ALK/ELM4 CISH Kit Figure 14.1 Map of ALK Gene on Chromosome 2 Figure 14.4 Legend G = Green ALK Break Apart R = Red Break Apart F = Fusion (Normal) CISH Figure 14.2 Normal Lung Tissue probed with ZytoVision ALK/ELM4 CISH Kit 2C SPEC ALK/ELM4 Break Apart Kit CISH Slide 32 *Information care of ZytoVision source: ZytoVision.com ZytoFast Hot Sellers Kappa/Lambda HPV EBV CMV Figure 15.1 Mechanism of Action for ZytoFast System Slide 33 CISH *Information care of ZytoVision source: ZytoVision.com Figure 16.1 ZytoFast HPV 6/11 with AP-BCIP/NBT Figure 16.2 ZytoFast IgK/IgL with HRP-AEC and AP-BCIP/NBT Figure 16.3 EBV with AP- NBT/BCIP Figure 16.4 EBV with HRP-DAB Slide 34 CISH ZytoFast PLUS for DIG labeled probes Top Sellers HPV Screening Probe Figure 17.1 Mechanism of Action for ZytoFast PLUS System Slide 35 CISH Figure 18.1 ZytoFast PLUS Kit Figure 18.2 Mechanism of Action for ZytoFast PLUS HPV Figure 18.3 HPV Tissue and ZytoFast Plus Kit Figure 18.4 Cervix Tissue and ZytoFast HPV High Rish with PLUS HRP/DAB Slide 36 PCR Slide 37 Partnership Single PCR Dual PCR Multiplex PCR Real Time PCR Slide 38 PCR Maxim Biotech Single/Dual/Multipl ex PCR Mutiplex - deletions/ampli fications of genes Multiple primers used Detect gene expression Profiling of genes and detection of pathogens Slide 39 PCR Slide 40 Slide 41 PCR Hot Sellers HIV HCV HBV HPV Genotype (13 types) Slide 42 PCR Real Time PCR Mutations, Fusion and Expression Detection Kits One Step Results in 90 minutes ISO/cGMP compliant Detects 1% mutant alleles Figure 19.1 - AmoyDx products in Cancer signaling products Slide 43 PCR Amoy Dx Top Sellers EGFR 3/4/29 Mutation Kits (lung, colon, etc.) BRAF (melanomas) EML4-ALK Fusion Kit (lung) KRAS (colorectal, lung) BCR-ABL (CML) Slide 44 PCR Fig 20.1 EGFR Structure Fig 20.2 Real Time PCR Slide 45 PCR Fig 21.1 AmoyDx EGFR Gene Mutations and Drug Sensitivity Fig. 21.4 29 Mutation Kit Fig. 21.3 4 Mutation Kit Fig. 21.2 3 Mutation Kit Slide 46 Markets Americas Asia Europe Fig 22.1 BioSB Primary Markets Slide 47 Bio SB Marketing Monthly Newsletter to customer and distributors Quarterly Distributor Webinars to discuss recent developments Mailers to promote Bio SB products/offers Website to promote monthly/quarterly specials For the most up to date information on the Bio SB line of molecular pathology products, visit www.biosb.comwww.biosb.com Slide 48 Questions? Thank You!