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MARK B brochure 2019

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Kyongsik Yun
Kyongsik Yun

BBB is a healthcare technology startup that has developed MARK BTM, a portable blood testing device, to provide accurate diagnostic results without requiring expensive medical infrastructure. MARK BTM uses a unique electrochemical immunoassay method to quantify blood proteins related to cancer and other diseases. It can detect markers for cancers like prostate, colon, liver and breast cancer as well as cardiovascular conditions. The portable device provides lab-quality results in 3-10 minutes using only 35 microliters of whole blood. BBB aims to make quality healthcare more accessible to help fight diseases like cancer worldwide.

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14F, 26, Samseong-ro 85-gil, Gangnam-gu, Seoul, Republic of Korea ©2019 BBB inc. All rights reserved. BBB® and MARK B™ are trademarks of BBB inc. Visit bbbtech.com now mail to biz@bbbtech.com call to +82-70-4407-8808 Quantitative Immunoassay Biosensor for hospital use for emergency use for home use for hospital use DocumentNumberMKT-10-1011,6/2019
Change Towards Innovation Cancer caused 43.8 million illness throughout the world and had burdened USD 1.16 trillion according to 2018 World Cancer Report, published by International Agency for Research on Cancer (IARC) of WHO. The prevalence rate is estimated to spike when people who have a cancer but not being diagnosed are included. Cancer has been prevalent nowadays and yet the disease still comes with fear and anxiety. To fight against cancer and get back to daily lives, “Quality healthcare service” is essential. But what if your’re not within the reach of skilled healthcare providers, up-to-date medical equipment and adequate medical insurance fund? The results speak for themselves.   BBB wanted to make a breakthrough. As a healthcare technology startup, we set a clear goal of launching a blood testing product which does not require high-end infrastructure to offer “Quality healthcare service.” Keeping this well-defined yet challenging ambition in mind, BBB took the first step towards developing MARK B™. MARK B™ should be more of a good testing product. A quality blood tester is all about “accuracy.” MARK B™ reads blood proteins in an “easy, quick and accurate” manner. EASY, QUICK and ACCURATE — these three keywords are feasible thanks to unique electrochemical immunoassay method. The sophisticated method presents accuracy equivalent to lab quality in a handy device, by selecting proteins with antibodies and analyzing electrochemical signal to draw quantitative results. Accurate content of a certain protein not only allows detecting early stage cancer but also monitoring patients under treatment. Presenting lab quality service outside the lab — the innovative experience for both healthcare professionals and patients. Another key technology behind MARK B™’s accurate diagnosis is non-powered automatic plasma separation. The tester automatically segregates pure (100%) plasma from traces of whole blood less than a single minute. It doesn’t need centrifugation before the test, optical elements or devices. That’s how BBB succeed in making more reliable and durable blood tester, MARK B™. BBB’s challenge is to pave the way for novel healthcare services through innovative technology. Change towards innovation — that’s the core value of MARK B™ and BBB. CEO & Founder of BBB, JAEKYU CHOI
MARK B™ focuses on the purpose of POCT Simple Precise Secure Adaptable Assay method Magnetic Electrochemical Sandwich ImmunoAssay key features Membrane-based power-free plasma separation Active mixing by magnetic force Turnaround time 3~10 minutes Sample  / Volume Whole blood 35µL *for PSA test Serum and plasma 20µL *for PSA test Limit of detection *lab-quality test range & results Tumor Markers PSA : 0.1 ng/mL CEA : 1 ng/mL AFP : 1 ng/mL CA19-9 : 1U/mL CA125 : 1U/mL Cardiovascular disease Markers cTnI : 50 pg/mL Myoglobin : 1 ng/mL CK-MB : 1 ng/mL NT-proBNP : 5pg/mL D-dimer : 50ng/mL hsCRP : 1μg/mL ST2 : 1.8ng/mL Galectin-3 : 1.1ng/mL Measurement Data Manager Communication with LIS, HIS, and other external system Cloud server to communicate with MARK B™ data POCT1-A2, HL7, FHIR® protocol to communicate with POC DMS Maintenance Manager Remote monitoring based on cloud server for device maintenance Automatic software update Monitoring device performance Connectivity Quantitative Immunoassay Biosensor www.bbbtech.com
Quantitative Immunoassay Biosensor www.bbbtech.com Quantify precisely by electrochemical measurement system Lab-Quality results lab-on-a-chip contains everything we need MARK B™ utilizes MESIA, a patented technology of BBB inc. MESIA : Magnetic Electrochemical Sandwich ImmunoAssay Accuracy Method comparison MARK B™ vs laboratory equipment (cobas e 801) High correlation with cobas e 801 (r = 0.997) OFF OFF Proteins in the plasma react with the magnetic nanoparticles 1 ON OFF Removal of unbound nanoparticles using magnetic fields 3 OFF ON Magnetic field drives the nanoparticles toward the electrode to form immunocomplexes 2 OFF OFF Measurement of electrochemical signal from the nanoparticles bound to the electrode 4 *Published Journal, Analytica Chimica Acta, vol. 1061, 2019 PSA 20 MARKBTM PSA(ng/ml) cobas e 801 PSA (ng/ml) R=0.996 30 10 0 10 20 30 AFP 600 MARKBTM AFP(ng/ml) cobas e 801 AFP (ng/ml) R=0.999 800 400 200 0 400200 600 800 CEA 200 MARKBTM CEA(ng/ml) cobas e 801 CEA (ng/ml) R=0.996 300 100 0 100 200 300
Behold the future of POCT Optimizing operational efficiency connected results direct to your network MARK B™ is designed to bring advanced POCT data management functionalities with flexible connectivity options that fit any healthcare needs. Protocols for communication Cloud server to communicate with MARK B™ test results POCT1-A2, HL7, FHIR® to communicate with MARK B™ and POC DMS Quantitative Immunoassay Biosensor www.bbbtech.com Test Results PDC DMS LIS/HIS EMR Patient Test Connected to wired hospital network Connected to hospital work station Hospital work station Wi-Fi MARK BTM Data Manager MARK BTM Maintenance Manager Managed Cloud *DMS : Data Management Sub-system
Quantitative Immunoassay Biosensor www.bbbtech.com Key Specification Test MarkersApplicable to all biomarkers with antigen-antibody response Assay method Magnetic Electrochemical Sandwich ImmunoAssay Sample type Fresh capillary whole blood, Heparinized venous whole blood, human serum, heparinized plasma Sample volume 35 µL for capillary whole blood, Heparinized venous whole blood. 20 µL for serum and heparinized plasma (PSA) *Depends on the analyte Measuring range 0.1 ~ 25 ng/mL (PSA) *Depends on the analyte Code matching and reference value method NFC Single use Single use only (test cartridge) Operating condition 2°C ~ 30°C Storage condition 2°C~ 30°C Quality control Control solution for checking the analyzer and the test cartridge Check cartridge for checking the analyzer Display 5.5” HD display, Touch screen OS Android 7.0 (Analyzer software) / Linux (Server) Memory capacity 8GB ROM / 1GB RAM / 1,000,000 test results Wireless LAN Wi-Fi 2.4GHz (IEEE802.11 b/g/n) Bluetooth BT 4.0 (used to read a patient code with barcode scanner) Port 4 USB ports for accessories, 1 USB port for Data Power rating : 12VDC, 1.5A plug interface : 5.5mm * 2.5mm Battery main battery : 1600mAh 3.7V sub battery : 2,600mAh 14.8V (3.7V 18650 4cell) Accessories *option thermal printer, barcode scanner Indicant Test item Disease / Disorder Clinical Trial 2019 2H 2020 1H 2020 2H Cancer AFP Liver, Hepatoma cancer ~11/30 CE FDA CEA Colon, Lung, Liver, Breast cancer ~11/30 CE FDA PSA Prostate cancer ~11/30 CE . FDA CA19-9 Pancreas, Colorectal ~11/30 CE FDA CA125 Ovarian, Endometrial cancer ~11/30 CE FDA Cardiovascular diseases cTnI Myocardial infarction ~12/31 CE FDA CK-MB Myocardial injury ~12/31 CE FDA Myoglobin Myocardial injury ~12/31 CE FDA D-dimer VTE. Pulmonary embolism ~12/31 CE FDA NT-proBNP Heart failure ~12/31 CE FDA hsCRP Inflammation CVD inflammatory disease ~12/31 CE FDA Galectin-3 Heart failure ~12/31 CE FDA ST2 Heart failure ~12/31 CE FDA Sepsis PCT Sepsis. Septic shock CE FDA IL-6 Sepsis. Septic shock CE FDA CRP Inflammation CE FDA Infectious diseases DVNS1 Dengue CE FDA Influenza A Influenza A CE . FDA Influenza B Influenza B CE . FDA

More Related Content

MARK B brochure 2019

  • 1. 14F, 26, Samseong-ro 85-gil, Gangnam-gu, Seoul, Republic of Korea ©2019 BBB inc. All rights reserved. BBB® and MARK B™ are trademarks of BBB inc. Visit bbbtech.com now mail to biz@bbbtech.com call to +82-70-4407-8808 Quantitative Immunoassay Biosensor for hospital use for emergency use for home use for hospital use DocumentNumberMKT-10-1011,6/2019
  • 2. Change Towards Innovation Cancer caused 43.8 million illness throughout the world and had burdened USD 1.16 trillion according to 2018 World Cancer Report, published by International Agency for Research on Cancer (IARC) of WHO. The prevalence rate is estimated to spike when people who have a cancer but not being diagnosed are included. Cancer has been prevalent nowadays and yet the disease still comes with fear and anxiety. To fight against cancer and get back to daily lives, “Quality healthcare service” is essential. But what if your’re not within the reach of skilled healthcare providers, up-to-date medical equipment and adequate medical insurance fund? The results speak for themselves.   BBB wanted to make a breakthrough. As a healthcare technology startup, we set a clear goal of launching a blood testing product which does not require high-end infrastructure to offer “Quality healthcare service.” Keeping this well-defined yet challenging ambition in mind, BBB took the first step towards developing MARK B™. MARK B™ should be more of a good testing product. A quality blood tester is all about “accuracy.” MARK B™ reads blood proteins in an “easy, quick and accurate” manner. EASY, QUICK and ACCURATE — these three keywords are feasible thanks to unique electrochemical immunoassay method. The sophisticated method presents accuracy equivalent to lab quality in a handy device, by selecting proteins with antibodies and analyzing electrochemical signal to draw quantitative results. Accurate content of a certain protein not only allows detecting early stage cancer but also monitoring patients under treatment. Presenting lab quality service outside the lab — the innovative experience for both healthcare professionals and patients. Another key technology behind MARK B™’s accurate diagnosis is non-powered automatic plasma separation. The tester automatically segregates pure (100%) plasma from traces of whole blood less than a single minute. It doesn’t need centrifugation before the test, optical elements or devices. That’s how BBB succeed in making more reliable and durable blood tester, MARK B™. BBB’s challenge is to pave the way for novel healthcare services through innovative technology. Change towards innovation — that’s the core value of MARK B™ and BBB. CEO & Founder of BBB, JAEKYU CHOI
  • 3. MARK B™ focuses on the purpose of POCT Simple Precise Secure Adaptable Assay method Magnetic Electrochemical Sandwich ImmunoAssay key features Membrane-based power-free plasma separation Active mixing by magnetic force Turnaround time 3~10 minutes Sample  / Volume Whole blood 35µL *for PSA test Serum and plasma 20µL *for PSA test Limit of detection *lab-quality test range & results Tumor Markers PSA : 0.1 ng/mL CEA : 1 ng/mL AFP : 1 ng/mL CA19-9 : 1U/mL CA125 : 1U/mL Cardiovascular disease Markers cTnI : 50 pg/mL Myoglobin : 1 ng/mL CK-MB : 1 ng/mL NT-proBNP : 5pg/mL D-dimer : 50ng/mL hsCRP : 1μg/mL ST2 : 1.8ng/mL Galectin-3 : 1.1ng/mL Measurement Data Manager Communication with LIS, HIS, and other external system Cloud server to communicate with MARK B™ data POCT1-A2, HL7, FHIR® protocol to communicate with POC DMS Maintenance Manager Remote monitoring based on cloud server for device maintenance Automatic software update Monitoring device performance Connectivity Quantitative Immunoassay Biosensor www.bbbtech.com
  • 4. Quantitative Immunoassay Biosensor www.bbbtech.com Quantify precisely by electrochemical measurement system Lab-Quality results lab-on-a-chip contains everything we need MARK B™ utilizes MESIA, a patented technology of BBB inc. MESIA : Magnetic Electrochemical Sandwich ImmunoAssay Accuracy Method comparison MARK B™ vs laboratory equipment (cobas e 801) High correlation with cobas e 801 (r = 0.997) OFF OFF Proteins in the plasma react with the magnetic nanoparticles 1 ON OFF Removal of unbound nanoparticles using magnetic fields 3 OFF ON Magnetic field drives the nanoparticles toward the electrode to form immunocomplexes 2 OFF OFF Measurement of electrochemical signal from the nanoparticles bound to the electrode 4 *Published Journal, Analytica Chimica Acta, vol. 1061, 2019 PSA 20 MARKBTM PSA(ng/ml) cobas e 801 PSA (ng/ml) R=0.996 30 10 0 10 20 30 AFP 600 MARKBTM AFP(ng/ml) cobas e 801 AFP (ng/ml) R=0.999 800 400 200 0 400200 600 800 CEA 200 MARKBTM CEA(ng/ml) cobas e 801 CEA (ng/ml) R=0.996 300 100 0 100 200 300
  • 5. Behold the future of POCT Optimizing operational efficiency connected results direct to your network MARK B™ is designed to bring advanced POCT data management functionalities with flexible connectivity options that fit any healthcare needs. Protocols for communication Cloud server to communicate with MARK B™ test results POCT1-A2, HL7, FHIR® to communicate with MARK B™ and POC DMS Quantitative Immunoassay Biosensor www.bbbtech.com Test Results PDC DMS LIS/HIS EMR Patient Test Connected to wired hospital network Connected to hospital work station Hospital work station Wi-Fi MARK BTM Data Manager MARK BTM Maintenance Manager Managed Cloud *DMS : Data Management Sub-system
  • 6. Quantitative Immunoassay Biosensor www.bbbtech.com Key Specification Test MarkersApplicable to all biomarkers with antigen-antibody response Assay method Magnetic Electrochemical Sandwich ImmunoAssay Sample type Fresh capillary whole blood, Heparinized venous whole blood, human serum, heparinized plasma Sample volume 35 µL for capillary whole blood, Heparinized venous whole blood. 20 µL for serum and heparinized plasma (PSA) *Depends on the analyte Measuring range 0.1 ~ 25 ng/mL (PSA) *Depends on the analyte Code matching and reference value method NFC Single use Single use only (test cartridge) Operating condition 2°C ~ 30°C Storage condition 2°C~ 30°C Quality control Control solution for checking the analyzer and the test cartridge Check cartridge for checking the analyzer Display 5.5” HD display, Touch screen OS Android 7.0 (Analyzer software) / Linux (Server) Memory capacity 8GB ROM / 1GB RAM / 1,000,000 test results Wireless LAN Wi-Fi 2.4GHz (IEEE802.11 b/g/n) Bluetooth BT 4.0 (used to read a patient code with barcode scanner) Port 4 USB ports for accessories, 1 USB port for Data Power rating : 12VDC, 1.5A plug interface : 5.5mm * 2.5mm Battery main battery : 1600mAh 3.7V sub battery : 2,600mAh 14.8V (3.7V 18650 4cell) Accessories *option thermal printer, barcode scanner Indicant Test item Disease / Disorder Clinical Trial 2019 2H 2020 1H 2020 2H Cancer AFP Liver, Hepatoma cancer ~11/30 CE FDA CEA Colon, Lung, Liver, Breast cancer ~11/30 CE FDA PSA Prostate cancer ~11/30 CE . FDA CA19-9 Pancreas, Colorectal ~11/30 CE FDA CA125 Ovarian, Endometrial cancer ~11/30 CE FDA Cardiovascular diseases cTnI Myocardial infarction ~12/31 CE FDA CK-MB Myocardial injury ~12/31 CE FDA Myoglobin Myocardial injury ~12/31 CE FDA D-dimer VTE. Pulmonary embolism ~12/31 CE FDA NT-proBNP Heart failure ~12/31 CE FDA hsCRP Inflammation CVD inflammatory disease ~12/31 CE FDA Galectin-3 Heart failure ~12/31 CE FDA ST2 Heart failure ~12/31 CE FDA Sepsis PCT Sepsis. Septic shock CE FDA IL-6 Sepsis. Septic shock CE FDA CRP Inflammation CE FDA Infectious diseases DVNS1 Dengue CE FDA Influenza A Influenza A CE . FDA Influenza B Influenza B CE . FDA