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 Products for Molecular Pathology. An Overview History of BioSB Our Mission Key Personnel Product Lineup Markets Marketing.

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Presentation on theme: " Products for Molecular Pathology. An Overview History of BioSB Our Mission Key Personnel Product Lineup Markets Marketing."— Presentation transcript:

1  Products for Molecular Pathology

2 An Overview History of BioSB Our Mission Key Personnel Product Lineup Markets Marketing

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

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

5 Key Personnel

6 Product Lineup

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

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

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

10 ImmunoCytochemistry Figure 3.1 Bio SB Immunocytochemistry Mechanism of Action Figure 3.2 Proprietary Liquid Cytology and ICC Kits; CytoDetector and CervicoDetector

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

12 Equipment & Slides

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

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

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

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 system…use any reagent or antibody Collaboration with ThermoFisher Scientific

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

18 Hydrophilic Plus Slides Figure 6.1 Hydrophobic versus Hydrophilic slide Tissue Detachment

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

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

21 CISH/FISH

22 Partnership FISH/CISH

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

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

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

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)

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

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

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

30 CISH *Information care of ZytoVision source: ZytoVision.com 2C SPEC ALK/ELM4 Break Apart Kit

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

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

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

34 CISH ZytoFast PLUS for DIG labeled probes Top Sellers HPV Screening Probe Figure 17.1 Mechanism of Action for ZytoFast PLUS System

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

36 PCR

37 Partnership Single PCR Dual PCR Multiplex PCR Real Time PCR

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

39 PCR

40

41 PCR “ Hot ” Sellers HIV HCV HBV HPV Genotype (13 types)

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

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)

44 PCR Fig 20.1 EGFR Structure Fig 20.2 Real Time PCR

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

46 Markets Americas Asia Europe Fig 22.1 BioSB Primary Markets

47 Bio SB Marketing Monthly Newsletter to customer and distributors Quarterly Distributor Webinar’s 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

48 Questions? Thank You!


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