MARK B magnetic electrochemical sandwich immunoassay

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.
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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