BioeXsen ADAPTABLE INNOVATIVE MOLECULAR SOLUTIONS www.bioexsen.com TABLE OF CONTENTS 4 5 6 7 8 9 10 About Us Product Portfolio: Human Health - Real-Time PCR Tests Where We Stand In The Test Markets Real-Time PCR Test Formats POC Application: Respiratory Swab Samples POC Automated Application: Respiratory Swab Samples POC Application: Sputum, Stool, Urine, And Genital & Rectal Swabs 11 POC Automated Application: Sputum, Stool, Urine, and Genital & Rectal Swabs 12 LAB Application: Blood, CSF, Tissue Samples 13 14 15 18 LAB Automated Application: Respiratory Swab Samples LAB Automated Application: Blood, CSF, Tissue Samples Ordering Information Upcoming Products 4 ABOUT US HUMAN HEALTH Real-Time PCR Test Kits Pathogen Detection Mutation Detection NGS Library Preparation Kits Whole Genome Sequencing Targeted Gene Sequencing MOLECULAR DIAGNOSTIC SYSTEMS Real-Time PCR Test Kits NGS Kits 47 R&D AND INNOVATION PROJECTS 2019-2022 BioeXsen’s Own Resources AMONG THE TOP 10 COMPANIES IN RESPIRATORY TRACT PATHOGEN TESTS 200 million tests were exported to 5 different continents during the pandemic period. Among the top 5 in the US market with FDA-authorized products. PRODUCTION AND R&D 7000 m2 3 million tests/day ISO 13485 and 9001 Hannover, Germany Istanbul, Turkey 5 5 PRODUCT PORTFOLIO: HUMAN HEALTH - REAL-TIME PCR TESTS Bacteria Virus RESPIRATORY TRACT INFECTIONS 22 24 BLOOD INFECTIONS 33 CENTRAL NERVOUS SYSTEM INFECTIONS 6 18 GASTROINTESTINAL INFECTIONS 20 5 TROPICAL FEVER 21 SEXUALLY TRANSMITTED INFECTIONS 8 URINARY TRACT INFECTIONS 22 HUMAN PAPILLOMAVIRUS INFECTIONS Antimicrobial Resistance 24 Fungi 9 6 6 5 2 1 13 6 28 Genotypes EYE INFECTIONS 1 6 1 BONE & JOINT INFECTIONS 26 FEVER & RASH INFECTIONS 3 13 10 IMMUNOCOMPROMISED INFECTIONS 6 12 2 TUBERCULOSIS WOUND INFECTIONS Parasite MTB complex NTM 23 1 XDR-TB MDR-TB 9 2 6 WHERE WE STAND IN THE POC TEST / THE CENTRAL LAB TESTING MARKET BioeXsen Cartridge-based PCR Systems Antigen Tests Test capacity in each operation 10-94 tests 2-16 tests 1 test Number of targets tested in each operation 1-31 targets 1-31 targets 1 target Test duration 29-55 min 25-90 min 15-20 min Consumable cost 1x ≥5x 1x Instrument cost 1x 2x-16x - Included Not Included Not Included 50-500 copies/mL 10-1000 copies/mL 106-109 copies/mL Sensitivity 95-100% 95-100% 60-70% Specificity 95-100% 95-100% 80-100% Ease of application Easy Effortless Easy Environmentally friendly Plastic waste 1x 100x 10x Contamination tracking Positive and negative controls Included Not Included Not Included BioeXsen Modular System Integrated System Test capacity in each operation 10-94 tests 10-94 tests 12-94 tests Number of targets tested in each operation 1-31 targets 1-31 targets 1-8 targets Test duration 29-55 min 180-240 min 120-180 min Consumable cost 1x 2x 3x Instrument cost 1x 8x 12x LoD 50-500 copies/mL 10-1000 copies/mL 10-1000 copies/mL Sensitivity 95-100% 95-100% 95-100% Specificity 95-100% 95-100% 95-100% Ease of application Easy Easy Easy Pathogen Inactivation Included Not Included Not Included Highlights of BioeXsen As fast as POC tests, high capacity up to central laboratory test volumes As cost effective as antigen tests Bio-safe Easy to apply as well as antigen tests Much more reliable results than antigen tests Parameters Pathogen Inactivation LoD Highlights of BioeXsen A wide portfolio of agents can be tested without compromising clinical performance with more than 2 times less time and cost invested Bio-safe Parameters 7 REAL-TIME PCR TEST FORMATS Single Reaction 1-4 Pathogens Panel Test 8 Reactions 8-31 Pathogens Lyophilize (Freeze-dry) Format Easy to apply Liquid Format Cost effective 8 POC APPLICATION: RESPIRATORY SWAB SAMPLES 1 min Pathogen Inactivation NA Release NA Preservation Automated Reporting RT-qPCR 29-45 min 15 sec A drop of sample / Ready t 1 min PCR nq se directly i ou Dried reagent in tube PCR set-up is not required 46 samples 94 samples RT-qPCR Automated Reporting 9 POC AUTOMATED APPLICATION: RESPIRATORY SWAB SAMPLES 1 min Pathogen Inactivation NA Release NA Preservation MYRA 5 min All Liquids Automated Transfer RT-qPCR 29-45 min Automated Reporting 15 sec / Ready t 1 min PCR nq se directly i ou The tube is placed directly into the robot Automated fluid transfer 46 samples 94 samples RT-qPCR Automated Reporting 8 10 POC APPLICATION: SPUTUM, STOOL, URINE, AND GENITAL & RECTAL SWABS 5min NA 5 min NA Release NA Preservation RT-qPCR 38-45 min Automated Reporting 15 sec A drop of sample / Dried reagent in tube Transfer to 5min NA Tube 5min NA Cycler PCR set-up is not required 46 samples 94 samples RT-qPCR Automated Reporting 11 POC AUTOMATED APPLICATION: SPUTUM, STOOL, URINE, AND GENITAL & RECTAL SWABS MYRA 5min NA 5 min 5 min All Liquids Automated Transfer NA Release NA Preservation Automated Reporting RT-qPCR 38-45 min 15 sec / The 5min NA tube is transferred directly into the robot Transfer to 5min NA Tube 5min NA Cycler Automated fluid transfer 46 samples 94 samples RT-qPCR Automated Reporting 8 12 LAB APPLICATION: BLOOD, CSF, TISSUE SAMPLES Robotic NA Extraction 27 min Automated Reporting RT-qPCR 38-45 min 15 sec A drop of sample / Dried reagent in tube Robotic NA Extraction PCR set-up is not required 46 samples 94 samples RT-qPCR Automated Reporting 13 LAB AUTOMATED APPLICATION: RESPIRATORY SWAB SAMPLES 1 min Pathogen Inactivation NA Release NA Preservation Ready t 1 min PCR nq se directly i ou STP Hands-free PCR Set-up from Capped Tubes MGISTP 7000 Automated Reporting RT-qPCR 29-45 min 192 sample, 40 min Capped vNAT® tubes are placed directly into the robot Automated lid opening and closing, barcode reading and fluid transfer 15 sec 94 samples RT-qPCR Automated Reporting 14 8 LAB AUTOMATED APPLICATION: BLOOD, CSF, TISSUE SAMPLES Hamilton Star/Starlet Compatible with all types of transfer tubes Hands-free NA extraction PCR set-up RT-qPCR Reporting From Sample to Result Report 90 min 15 ORDERING INFORMATION Sample Prep Solutions BioeXsen 5min NA 500 Rxns - BX-NA-514 vNAT® Buffer 100 Rxns / 250 Rxns / 500 Rxns / 1000 Rxns - T00011 / T00012 / T00008 / T00010 vNAT® Buffer - 1X 250 mL - 1X concentration - T00013 vNAT® Transfer Tube* 100 Tubes - BS-NA-513m-100 Respiratory Tract Infections BioeXsen Respiratory Tract RT-qPCR MX-24 Panel Virus SARS-CoV-2 Influenza A Influenza B Human Coronavirus 229E Human Coronavirus OC43 Human Coronavirus NL63 Human Coronavirus HKU1 Human Parainfluenza 1 Human Parainfluenza 2 Human Parainfluenza 3 BX-SY-MX24S-25 / BX-SY-MX24S-100 / BX-SY-MX24T-25 / BX-SY-MX24T-100 Human Parainfluenza 4 Human Metapneumovirus (MPV) Respiratory Syncytial Virus (RSV) A/B Enterovirus (HEV)/Human Rhinovirus (HRV) BioeXsen SARS-CoV-2 RT PCR Adenovirus (AV) Human Bocavirus (HBoV) Human Parechovirus (HPeV) Bacteria Legionella pneumophila Mycoplasma pneumoniae Chlamydophila pneumoniae Haemophilus influenzae Bordetella pertussis Streptococcus pneumoniae 100 Rxns / 1000 Rxns - T00042 / T00044 SARS-CoV-2 BioeXsen SARS-CoV-2 Double Gene RT-qPCR 100 Rxns / 250 Rxns / 500 Rxns / 1000 Rxns - T00099 / T00100 / T00101 / T00102 SARS-CoV-2 BioeXsen SARS-CoV-2 Triple Gene RT-qPCR Kit 100 Rxns / 250 Rxns / 500 Rxns / 1000 Rxns - BX-SY-WCOR-308-100 / BX-SY-WCOR-308-250 / BX-SY-WCOR-308-500 / BX-SY-WCOR-308-1000 SARS-CoV-2 Bio-Speedy® SARS-CoV-2 (2019-nCoV) RT-qPCR Detection Kit** 100 Rxns / 1000 Rxns - BS-SY-WCOR-304-100 / BS-SY-WCOR-304-1000 SARS-CoV-2 BioeXsen SARS-CoV-2 Variant Plus SARS-CoV-2 Omicron BA.1 Variant BioeXsen SARS-CoV-2 Variant Plus V2 SARS-CoV-2 Alpha Variant Beta Variant 100 Rxns / 250 Rxns / 500 Rxns / 1000 Rxns - T00315 / T00314 / T00319 / T00316 Omicron BA.2 Variant Gamma Variant Delta Variant Omicron Variant * BioeXsen Gmbh is authorized distributor of Bioeksen R&D Technologies Inc. for vNAT® Transfer Tube ** BioeXsen Gmbh is authorized distributor of Bioeksen R&D Technologies Inc. for Bio-Speedy® SARS-CoV-2 (2019-nCoV) RT-qPCR Detection Kit 100 Rxns / 250 Rxns / 500 Rxns / 1000 Rxns - T00325 / T00324 / T00329 / T00326 16 ORDERING INFORMATION BioeXsen SARS-CoV-2 + Omicron RT-qPCR 250 Rxns / 500 Rxns / 1000 Rxns - BX-SY-WCOR-405-250 / BX-SY-WCOR-405-500 / BX-SY-WCOR-405-1000 SARS-CoV-2 Omicron Variant Omicron BA.2 Variant BioeXsen COVID-19/Flu RT-qPCR 100 Rxns / 250 Rxns / 500 Rxns / 1000 Rxns - BX-SY-SI-100 / BX-SY-SI-250 / BX-SY-SI-500 / BX-SY-SI-1000 SARS-CoV-2 Influenza A Influenza B BioeXsen COVID-19/Flu/RSV RT-qPCR Kit SARS-CoV-2 Influenza A 100 Rxns / 250 Rxns / 500 Rxns / 1000 Rxns - BXC19FR01100 / BXC19FR01250 / BXC19FR01500 / BXC19FR011000 Influenza B Respiratory Syncytial Virus (RSV) Tuberculosis BioeXsen MTB qPCR Kit 25 Rxns / 100 Rxns - BX-MTB-T-25 / BX-MTB-T-100 Bacteria Mycobacterium tuberculosis complex Central Nervous System Infections BioeXsen Meningitis/Encephalitis RT-qPCR MX-17 Panel 25 Rxns / 100 Rxns - BX-ME-MX24S-25 / BX-ME-MX24S-100 / BX-ME-MX24T-25 / BX-ME-MX24T-100 Varicella-zoster virus Virus Herpes simplex virus 1 Human herpesvirus 7 Enterovirus Herpes simplex virus 2 Human herpesvirus 8 Human herpesvirus 6 Cytomegalovirus (CMV) Human parechovirus Bacteria Listeria monocytogenes Haemophilus Influenzae Escherichia coli K1 Neisseria meningitidis Streptococcus agalactiae Streptococcus pneumoniae Fungi Cryptococcus gattii/neoformans Gastrointestinal Infections BioeXsen Gastroenteritis RT-qPCR MX-24 Panel Virus Sapovirus (GI/GII/GIV/GV) Astrovirus Norovirus (GI/GII) Rotavirus (A) Adenovirus 25 Rxns / 100 Rxns - BX-GE-MX24S-25 / BX-GE-MX24S-100 / BX-GE-MX24T-25 / BX-GE-MX24T-100 Bacteria Salmonella spp. Campylobacter spp. Vibrio parahaemolyticus Vibrio cholerae Yersinia enterocolitica EnterotoxigenicE. coli (ETEC) Plesiomonas shigelloides Shigella/EnteroinvasiveE. coli (EIEC) Clostridium difficile Clostridium difficile binary toxin A EnteroaggregativeE. coli (EAEC) Shiga toxin producingE. coli (STEC) Clostridium difficile binary toxin B Clostridium difficile binary toxin A/B EnteropathogenicE. coli (EPEC) Parasitic Giardia lamblia Agents Entamoeba histolytica Cryptosporidium spp. Cyclospora cayetanensis Blood Infections BioeXsen Sepsis qPCR MX-30 Panel Gram (-) Neisseria meningitidis Bacteria Enterobacteriaceae Pseudomonas aeruginosa Klebsiella pneumoniae Acinetobacter baumannii Haemophilus Influenzae 25 Rxns / 100 Rxns - BX-SE-MX30S-25 / BX-SE-MX30S-100 / BX-SE-MX30T-25 / BX-SE-MX30S-100 Klebsiella oxytoca Escherichia coli Stenotrophomonas maltophilia Pseudomonas spp. Gram (+) Streptococcus spp. Bacteria Streptococcus pneumoniae Staphylococcus spp. Staphylococcus aureus Listeria monocytogenes Enterococcus faecium Enterococcus faecalis Fungi Antimicrobial VanA - Vancomycin resistance Resistance VanB - Vancomycin resistance mecA+C - Methicillin resistance OXA-48 - Carbapenem resistance KPC - Carbapenem resistance NDM - Carbapenem resistance VIM - Carbapenem resistance IMP - Carbapenem resistance Candida glabrata Candida tropicalis Candida krusei Candida albicans Candida parapsilosis 17 ORDERING INFORMATION Fever & Rash BioeXsen Monkeypox Virus qPCR Kit 25 Rxns - BX-MPV-25 Monkeypox Virus Human Papillomavirus BioeXsen Human Papillomavirus High-Risk qPCR Panel Virus HPV-16 HPV-18 HPV-31 HPV-33 HPV-35 HPV-39 HPV-45 HPV-51 25 Rxns / 100 Rxns - BX-HRHPV-T-25 / BX-HRHPV-T-100 / BX-HRHPV-S-25 / BX-HRHPV-S-100 HPV-52 HPV-56 HPV-58 HPV-59 HPV-66 HPV-68 Sexually Transmitted Infections BioeXsen Sexually Transmitted Infection RT-qPCR Panel Virus Herpes simplex virus 1 Herpes simplex virus 2 25 Rxns / 100 Rxns - BX-STI-T-25 / BX-STI-T-100 / BX-STI-S-25 / BX-STI-S-100 Bacteria Mycoplasma genitalium Neisseria gonorrhoeae Chlamydia trachomatis Treponema pallidum Ureaplasma parvum/ urealyticum Mycoplasma hominis Gardnerella vaginalis Parasite Trichomonas vaginalis Urinary Tract Infections BioeXsen Urinary Tract Infections qPCR Panel Bacteria Acinetobacter baumannii Staphylococcus aureus Klebsiella pneumoniae Morganella morganii Staphylococcus saprophyticus Aerococcus urinae Pseudomonas aeruginosa Enterococcus faecium Streptococcus agalactiae Providencia stuartii Treponema pallidum Enterococcus faecalis 25 Rxns / 100 Rxns - BX-UTI-T-25 / BX-UTI-T-100 / BX-UTI-S-25 / BX-UTI-S-100 Ureaplasma urealyticum Ureaplasma parvum Klebsiella aerogenes Proteus vulgaris Enterobacter cloacae Serratia marcescens Citrobacter freundii Proteus mirabilis Escherichia coli Klebsiella oxytoca Antimicrobial KPC-Carbapenem resistance Fungi Candida spp. Resistance Van A/B - Vancomycin resistance Candida albicans mecA-mecC - Methicillin resistance CTX-M - ESBL 18 UPCOMING PRODUCTS Lower Respiratory Bacteria qPCR Panel Streptococcus agalactiae Haemophilus influenzae Moraxella catarrhalis Pseudomonas aeruginosa Staphylococcus aureus Acinetobacter calcoaceticus-baumannii complex Chlamydophila pneumoniae Mycoplasma pneumoniae Legionella pneumophila Klebsiella pneumoniae Streptococcus pneumoniae Streptococcus pyogenes Enterobacter cloacae complex Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Proteus spp. Serratia marcescens Tropical Fever RT-qPCR Panel West Nile virus Yellow fever virus Zika virus Mayaro virus Brucella spp. Burkholderia pseudomallei Coxiella burnetii Chikungunya virus Crimean-Congo hemorrhagic fever virus Dengue virus Ebola virus Hantaan virus Japanese encephalitis virus Rift Valley fever virus Leptospira spp. Rickettsia spp. Salmonella spp. Streptococcus pneumoniae Leishmania spp. Plasmodium spp. Immunocompromised Testing qPCR Panel Cytomegalovirus (CMV) Epstein-Barr virus (EBV) BK virus JC virus Adenovirus Herpes simplex virus 1/2 Human herpes virus 6/7 Human herpes virus 8 Human parvovirus B19 Varicella-zoster virus Pneumocystis jirovecii Aspergillus spp. Human Papillomavirus Genotyping qPCR Panel Human papillomavirus 6 (HPV 6) Human papillomavirus 11 (HPV 11) Human papillomavirus 16 (HPV 16) Human papillomavirus 18 (HPV 18) Human papillomavirus 26 (HPV 26) Human papillomavirus 31 (HPV 31) Human papillomavirus 33 (HPV 33) Plasmodium qPCR Panel Plasmodium falciparum Plasmodium malariae Plasmodium ovale Plasmodium vivax Plasmodium knowlesi Human papillomavirus 35 (HPV 35) Human papillomavirus 39 (HPV 39) Human papillomavirus 40 (HPV 40) Human papillomavirus 42 (HPV 42) Human papillomavirus 43 (HPV 43) Human papillomavirus 44 (HPV 44) Human papillomavirus 45 (HPV 45) Human papillomavirus 51 (HPV 51) Human papillomavirus 52 (HPV 52) Human papillomavirus 53 (HPV 53) Human papillomavirus 54 (HPV 54) Human papillomavirus 56 (HPV 56) Human papillomavirus 58 (HPV 58) Human papillomavirus 59 (HPV 59) Human papillomavirus 61 (HPV 61) Human papillomavirus 66 (HPV 66) Human papillomavirus 68 (HPV 68) Human papillomavirus 69 (HPV 69) Human papillomavirus 70 (HPV 70) Human papillomavirus 73 (HPV 73) Human papillomavirus 82 (HPV 82) Bioexsen GmbH Bioexsen GmbH www.bioexsen.com bioexsenhealthcare www.bioexsen.com Hindenburgstrasse 34a, 82343 Poecking-GERMANY Phone: +49 172 413 25 28 e-mail: info@bioexsen.com
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