Biotest Overview March 2009

Biotest Blood Bank Solutions March 5 th , 2009

Presentation Overview Who is Biotest? Traditional Blood Bank Reagents Product offerings Biotest Blood Bank Automation Overview

Biotest – 60+ years of Transfusion Diagnostics 2005 Tango Automated Blood Bank Analyzer launched in US/Canada Manual reagents cleared in Canada and submitted to FDA TANGO optimo launched FDA approves Tango Optimo expanded menu and manual reagents 1948 Introduced World’s First Anti-D test serum 1983 Seraclone, Monoclonal Antibodies for Blood Grouping developed 1985 Erytype introduced, Ready to Use Microplates for Blood Grouping 1946 Founded as Biotest Serum-Institut GmbH

Biotest Diagnostics Corporation USA Founded in 1982, wholly owned subsidiary of Biotest AG Company Headquarters- Rockaway, NJ Historical Product lines Transplant HLA Serological and Molecular Typing Reagents and Automation Industrial Microbiology- Clean Room Monitoring Particle counters Air Samplers Agar media

Biotest Diagnostics Corporation Late 2006 Transfusion Product Lines Distribution of manual blood bank reagents in Canada TANGO Automated Blood Bank System March 2008 Moved to a new facility in Rockaway, NJ To support growth from new products and additional customer support activities

New Biotest Diagnostics Headquarters Three state-of-the-art labs Customer training facility Equipment service center Customer service & support Warehousing & distribution

BDC Transfusion Management Personnel – 40% increase since 2006 to accommodate transfusion Upper Management Bill Weiss – President, BDC BS Chemistry, MBA Abbott - Sales & Marketing Abbott Immucor – Director of Sales Candace Williams – VP, Diagnostics Division MT(ASCP), SBB 13 yrs hospital transfusion service 17 yrs, Olympus blood bank product division John Beck – Director of Sales Immucor - 8 yrs experience sales, sales management and marketing experience

Traditional Blood Bank Reagents Available in Europe, Canada and USA. Submitted to U.S. FDA, approved on August 15 th , 2008

Traditional Blood Bank Reagents ABO/Rh antisera A, B, A,B D Blend – weak D D 226 – RT, no weak D claim Control Anti-Human Globulin (AHG) Anti-IgG Polyspecific Reagent Red Cells Screening cells – three options Two panels A1, B, A2 cells Rare Antisera C, E, c, e, K, k, Jk a , Jk b , S, s, M, N, Fy a , Le a , P1 Potentiators & Controls

Rh Antisera IgM antibodies anti-D detects D weak but not category D VI monoclonal => short or no incubation (IS-5’ RT) high specificity, high avidity- strong reaction low protein content- suitable for all techniques except antiglobulin test BS226 MS24 MS33 MS12/MS260 MS16/MS21 /MS63 Seraclone ® Anti-D (RH1) Seraclone ® Anti-C (RH2) Seraclone ® Anti-c (RH4) Seraclone ® (2) Anti-E (RH3) Seraclone ® (3) Anti-e (RH5) 3 clones (1 IgM, 2 IgG) suitable for all techniques including Antiglobulin detects all D’s BS242/ BS221/ H411B7 Seraclone ® Anti-D (RH1) Blend Features Clones Product

Rare Antisera 5’ RT 5’ RT 5’ RT 5’ RT 5’ RT 30’ RT 30’ RT 5’ RT IAT IAT 5’ RT MS56 (IgM) Lk1 (IgM) MS15 (IgM) MS8 (IgM) LeA2 (IgM) BS57 (IgM) BS41 (IgM) MS94 (IgM) P3YAN3 (IgG) DG-FYA-02 (IgG) 650 (IgM) Seraclone® Anti-K (KEL1) Seraclone® Anti-k (KEL2) Seraclone® Anti-Jka (JK1) Seraclone® Anti-Jkb (JK2 Seraclone® Anti-Lea (LE1) Seraclone® Anti-M (MNS1) Seraclone® Anti-N (MNS2) Seraclone® Anti-S (MNS3) Seraclone® Anti-s (MNS4) Seraclone® Anti-Fya (FY1) Seraclone® Anti-P1 (P1) Test Method Clones Product

Reagent Red Cell Products Antibody Screen Pooled cell 2 cell R1R1 (CDe/CDe) and R2R2 (cDE/cDE) Homozygous expression of Jka 3 cell screen R1R1 (CDe/CDe), R2R2 (cDE/cDE), and rr (cde/cde) Homozygous expression of Jka and Fya Antibody Identification 8 cell, 11 cell panels 4 ml fill volume ABO A1, A2 and B cells

Additional Manual Reagents AHG Reagents Anti-IgG (light chain) Polyspecific Anti-IgG + C3d IgG Coated Control RBC LISS (MLB2)

Traditional Reagents: The Biotest Advantage Biotest antisera all monoclonal Biotest rare antisera do not require antiglobulin phase except anti-s & anti-Fy a Biotest panels have 4 ml vs. 3 ml fill volume 16 of 20 Biotest antisera specificities represent new clones for the US market

Traditional Reagent Evaluation Mike Charapata, Manager, Transfusion Services, Puget Sound Blood Center Presented at 2008 AABB Annual Meeting, Montreal, 2008 Evaluated Biotest rare antisera in comparison to Immucor and Ortho

Results of Rh Antisera Evaluation Biotest Significantly Outperforms 61 4 96 Anti-e 108 110 110 97 Number of samples tested Roughly Equivalent 10 14 Anti-c Roughly Equivalent 5 3 Anti-E Roughly Equivalent 29 14 Anti-C Roughly Equivalent 18 14 Anti-D Blend Conclusion # Stronger with Biotest Rgts # Stronger with Reference Rgts Antisera

Rare Antisera Evaluation Biotest Outperforms 17 2 31 Anti-s Biotest Outperforms 10 0 31 Anti-S Roughly Equivalent 6 2 30 Anti-N Roughly Equivalent 0 1 11 Anti-k Equivalent 0 0 41 Anti-K Conclusion # Stronger with Biotest Rgts # Stronger with Reference Rgts # Samples tested Antisera

Rare Antisera Evaluation Roughly Equivalent 4 0 30 Anti-Lea Biotest Outperforms 10 0 18 Anti-P1 Roughly Equivalent 2 2 31 Anti-Jkb Roughly Equivalent 3 8 31 Anti-Jka Biotest Outperforms 11 0 31 Anti-Fya Conclusion # Stronger with Biotest Rgts # Stronger with Reference Rgts # Samples tested Antisera

Rare Antisera Evaluation Conclusions Performance qualification Anti-e significantly outperforms reference reagents Anti-S, -s, -Fya, and –P1 shows stronger reactivity than reference reagent All reagents show at least equivalent reactivity Test Methodology = ease-of-use Labor and time savings due to number of antisera not requiring antiglobulin phase

Traditional Reagents: The Biotest Advantage Biotest antisera all monoclonal 16 of 26 Biotest antisera specificities represent new clones for the US market Biotest rare antisera do not require antiglobulin phase except anti-s & anti-Fy a 5’ RT - Anti-S, anti-K, anti-k, anti-P1 15’ RT - Anti-Jka, anti-Jkb, anti-Lea Biotest panels have 4 ml vs. 3 ml fill volume Many of the Rh and Rare antisera exhibit greater avidity (reaction strength) and ease-of-use vs. other supplier’s products

Fully-automated instrument for the hospital transfusion service, prenatal testing and donor centers .

Features Flexibility Batch or random access analyzer Two, Three or Pooled antibody screening options 2 STAT modes (Emergency and Express) User-Friendly - As easy as 1-2-3. (Load sample, confirm order, press start). Seven day on-board reagent and microplate storage In addition: Batch or single sample result validation Enhanced automated maintenance Automated QC testing – only once per day

Microplate Storage 10 plates 7 days on-board Plate Loading Plate barcodes Strip barcodes Transport Channel Individual strips Test setup and mixing RT and 37C incubation Transport Channel Centrifugation Washing Add AHG, if required Results Interpretation Measurement chamber Transport belt to waste Liquid Reagent Storage 7 day on-board storage RT and refrigerated storage Continuous access Reads barcodes Sample Loading Continuous loading Holds 144 samples

Erytype and Solidscreen Platform Eight wells/strip Strips move through instrument – not plates 12 strips/plate Barcoded strips and plates Product Strip number Lot number Strip type Expiration date

Superior Reagent Stability Microplates Erytype Strips Solidscreen Strips Liquid Reagents AHG/IgG MLB (LISS) Reverse Cells Screen Cells Bromelin On-board 7 Days 7 Days 7 Days 7 Days 7 Days 7 Days 24 Hours Shelf-life 18 months 2 years 2 years 18 months 5 weeks 5 weeks 6 months

ABO/Rh Methodology Erytype S Standard hemagglutination testing Monoclonal antisera dried in microwells Reduces waste from dead volume Reduces reagent loading Reduces solid waste 7 day onboard shelf-life 18 month product shelf-life

ABO/Rh Method Wells coated with dried monoclonal antisera Red cells suspended in bromelin are pipetted into wells Antisera dissolves, test mixture incubated Centrifugation and resuspension of test mixture TANGO interprets well images

TANGO ABO/Rh Results Grades reactions Makes interpretation Compares with historical results Stores results and interpretations (~15,000 patients)

Field Trial ABO/Rh NTD Rates 51% ABO NTD due to patients condition, multiple transfusions, oncology, bone marrow transplant, etc. 24% due to clots/fibrin 21% due to weak isohemagglutinins 4 % Miscellaneous causes 0.1% Rh 0.03% Rh ABO ABO 0.7% Donor Samples n = 3,208 1.8% Patient Samples n = 3,449 NTD Rate after repeat testing

Antiglobulin Test Methodology Solidscreen II Microplate configuration Strip and plate barcode process controls On-board shelf-life is 7 days Product shelf-life is 2 years Unique solidscreen methodology

Microplate well contains a layer of Protein A, which has a high affinity for the Fc portion of the Anti-Human Globulin (Anti-IgG)

Screening RBC’s are coated with patient antibodies, if antibodies are present in serum/plasma Plasma or serum added to well, followed by MLB (modified LISS) and screening cells Incubates for 20 min at 37 degrees

Sensitized RBC’s and Anti-IgG bind with Protein A on well surface Unsensitized RBC’s form button at bottom of well Wells are washed with PBS Anti-IgG is added to the wells

Solidscreen II Reaction Patterns Positive Antibody Screen Negative Antibody Screen

Field Trial Sensitivity by Method

Antibodies Not Detected By TANGO Passive anti-D Anti-E (3) IgM (1) +/- LISS (1) Anti-C (Gel -, LISS w+) Anti-M (2) By Reference Method Anti-D Anti-E (3) Anti- E, K Anti-K Anti-E, Jka Anti-M Anti-Lua

Linauts S, Lammers C, Transfusion, Vol. 44, No. 9S, 2004, p. 123A . anti-C anti-Jka anti-C+Jka anti-E anti-K anti-D anti-c+Jka anti-c x2 anti-I anti-M x 2 anti-C (wk +) anti-D (micro +) 59 50 9 Total 16 16 0 2 to 3+ 30 25 5 w to 1+ 13 9 4 Neg Total Positive Negative LISS Tube Results (post-thaw) Solidscreen II Results Known Antibody Positive Samples (n=59)

Comparison of Solid-Phase Antibody Screening Tests with Pooled Red Cells in Blood Donors Reference: Vox Sang 1996;71:37-42 Solid-phase antibody screening in 10,008 blood donors Technique number of Detection of donors with donors detected IgG Antibodies (n=41) IgG a nonspecific b sensitivity specificity test % % efficiency c Capture R Ready Screen 40 61 97.6 99.39 1.40 Solidscreen II (polyspecific AHG) 39 11 95.1 99.88 1.89 Solidscreen II – (Anti-IgG) 38 2 92.7 99.98 1.95 Total d 41 67 a Correct positive test result: IgG antibody with blood group specificity detected. b False-positive test result: nonspecific positive reactions with all panel cells including the autocontrol. c The test efficiency (result validity) is the sum of the predictive values for positive and negative test results. A value of 2.0 indicates an optimal test efficiency.

Comparative Studies in Antibody Screening of Blood Donations with Three Different Pooled Red Blood Cell Reagents O. Mannherz, B. Siebert, E. A. Scharberg Biotest Medical Diagnostics, Dreieich, Germany; DRK-BSD-Nord, Institut Lütjensee, Germany; DRK-BSD Baden-Württemberg-Hessen, Institut Baden-Baden, Germany Tested 19,130 using pooled reagent red cells for Solidscreen II and Capture R Used semi-automated methods (workstations) Specificity Sensitivity Solidscreen II 100% 89.2% Capture R 99.8% 90% Positive Predictive value (probability that when the test is positive that it contains an antibody Solidscreen II 97.9% Capture R 45% (80 positive results/ only 32 were true antibodies) Conclusion “ Extremely low rate of false positives with Solidscreen II is highly beneficial by reducing the amount of extra work required to resolve false positives.”

Load and walk away 144 sample loading capacity 12 Racks with 12 samples each Continuous availability for sample loading and unloading

Ordering Tests Random Access Analyzer LIS ordering via bidirectional interface Operator ordering via touchscreen/keyboard/mouse Individually by sample All samples on screen Batch Analyzer Barcoded sample rack – orders same tests for all samples in rack Stat Testing Add Stat samples at any time Change sample status to Stat at any time prior to sampling TANGO skips routine samples and pipettes stats as first sample in next “mini-batch” (4 samples)

Sample Requirements Use of primary tubes Serum or plasma samples for antibody screening All common tubes can be used simultanously (10-16,5mm diameter, 20-115 mm height) Positive sample identification All common barcodes can be read including ISBT code 128 Sample requirements 500 ul minimum Barcodes on sample rack The rack barcodes can be used to define single tests or test profiles.

Reagent Loading and Storage 12 cooled/ 6 RT positions Cells are kept in suspension Automatically reads reagent barcodes upon loading True level sensing 7-day on-board shelf-life for all reagents except bromelin Tracks on-board shelf-life Can load multiple vials or lot numbers of same reagent

Sample Throughput 25 ABO/Rh tests per hour 60 Antibody screens per hour (2 wells) 50 ABO/Rh Confirmations per hour Time to complete One ABO/Rh 17 minutes Four ABO/Rh 22 minutes One Type and Screen 32 minutes Four Type and Screens 37 minutes

The Advantage Easy to operate: Flexible operations; continuous access capability Load samples, request tests, press start Stores reagents for multiple assay types Happier techs! - Easy to use by generalists & dedicated staff Low Operating Costs: QC only once a day – Controls not required with each sample or batch Two, three or pooled screen cell options Excellent specificity/sensitivity = fewer repeats On-board reagent storage (7 days) = minimal reagent waste Increased Productivity True Stat capability - Linear rack system means no lock out period Daily maintenance in less than 10 minutes Excellent process control Less reagent manipulation

Biotest Overview March 2009

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