MISSION. Global Top Digital POCT Creator. Customer. Market. Future. Oriented Service. Oriented. Oriented Management. Global.

Transcription

1 One step Rapid Test

2 Global Top Digital POCT Creator MISSION Customer Market Future Oriented Service Oriented R&D Oriented Management CreActiver Creator We Create Integrated Platform Based On The Way Of People s Life SK Insight Network Expert Culture & Trend Leader Niche Market Marketing Matchless Convergence Novel Tool Engineering Platform Digital POCT We Deliver Compact, Personalized, Connected Device Global Over 100 Million Dollars Global Sales by 2020

3 Global Top Digital POCT Creator CONTENTS About NanoEnTek FREND TM System Urology Thyroid Function Cardiac Marker Procalcitonin, Vitamin D BUDDI TM BioTracer TM Hepatitis Infectious diseases Tumor marker Fertility Hormone Acute myocardial infarction (AMI) ELISA ADAM-rWBC ADAMII-CD34 01 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

4 2 OVERVIEW Through active investment, NanoEnTek is now expanding in-vitro diagnostic business with existing life science business. In January 2016, we merge with Biofocus which is a point of care diagnostic devices company based on rapid kit. We have reinforced biology capability and present customized products for each country because of diversification in platform. Until 2020, NanoEnTek will develop as a global leader in point of care diagnostic device area through advanced and various area like immunoassay, blood cell count, companion diagnostics, clinical chemistry, and so on. Name of Company NanoEnTek Inc. Establishment June 2000 Stock market Listed in KOSDAQ (039860) HQ Office 12F, 5, Digital-ro 26-gil, Guro-gu, Seoul, Korea Factory Seohae-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do, Korea US Branch 5627 Stoneridge Drive Suite 304, Pleasanton, CA, USA Main Business Researching, Development and Manufacturing of In Vitro Diagnostics & Life Science Products In Seoul NanoEnTek Inc.(HQ) In Hwaseong NanoEnTek Factory In San Francisco, CA NanoEnTek USA Inc. HISTOR OF GROWTH Establish Digital Biotechnology (venture in Seoul National University) NanoEnTek listed on KOSDAQ (stock exchange) Establish corporation in the United States Build factory in Hwaseong, Korea Supply contract for Countess with Life Technologies Sell-off patent to Life Technologies [us 13m$] Contract new products development with Life Technologies Strartegic partnership with SK telecom (invest US 23M$)

5 Global Top Digital POCT Creator 3 TECHNICAL ADVANTAGE of OUR PLATFORM 1 ST MEMS & MICRO-FLUIDIC CONTROL 2 ND OPTIMIZED FLUORESCENCE NANO PARTICLE Microelectromechanical systems (MEMS, also written as micro-electro-mechanical, MicroElectroMechanical or microelectronic and microelectromechanical systems and the related micromechatronics) is the technology of very small devices; it merges at the nano-scale into HPERLINK nanoelectromechanical systems (NEMS) and HPERLINK nanotechnology Fluoscent Micro particle systems has advanced rapidly over the last few years, and these exciting scientific developments are being translated into a new generation of high technology products and processes. Nanotechnology has the potential to impact a wide range of applications, from chemicals to electronics, to sensors, to advanced materials Enlarge Hwaseong factory ADAM-rWBC FDA 510(k) cleared on the United States FREND TM PSA PLUS FDA 510(k) cleared in the United States FREND TM TSH FDA 510(k) cleared in the United States SK telecom become the largest shareholder ADAM-rWBC CFDA cleared in China FREND TM PSA PLUS CFDA cleared in China M&A with Biofocus (Rapid kit diagnostic company) FREND TM Free T4 FDA 510(k) cleared in the United States FREND TM BNP CFDA cleared in China FREND TM Testosterone FDA 510(k) cleared in the United States FREND TM Vitamin D FDA 510(k) cleared in the United States

6 4 SSTEM FDA 510K Cleared ACCELERATING DECISION-MAKING Accurate and fully automated FREND TM System offers fast result. With simple 3 steps operation and wide range of disease markers, the system supports your quick decision-making.

7 Global Top Digital POCT Creator EAS & FAST OPERATION PROCEDURE Basic Step 1 Add sample Using AP System Step 1 Insert cartridge Using Heating block Step 1 Load sample - Diagnose with only 35 μl of sample volume - 3 simple step to quick result - Report test result in 3 min Patient will have test result before they leave doctor s office No retrieving test results from an outside lab Step 2 Load sample Step 2 Insert cartridge Step 2 Incubate cartridge and tube Step 3 Insert AP tube Step 3 Get results Step 4 Get results Step 3 Get results 5 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

8 6 SUPERIOR ACCURAC Demonstrate high correlation FREND TM PSA Plus(ng/mL) y = x R 2 = Laboratory equipment(ng/ml) equlpment(ng/ml) (Source : NanoEnTek R&D)

9 Global Top Digital POCT Creator EXCELLENT QUALIT CONTROL Control FREND TM System quality in 1 min The FREND TM System Checks Lot-to-Lot variations; Code chip correct Example : Calibration Curve Concentration(ng/ ) (ml) Laser Power LOT A y = 1.05x x LOT B y = 0.74x x Ratio (Test/Reference) FREND PSA Plus Code Chip The code chip which saved lot-dependent parameter of calibration curve is provided with each cartridge Box Laser Alignment Lab to Lab Variations Calculate Ratio Bio-Rad Liquicheck TM Immunoassay Plus Control CLINIQA Liquid QC TM Tumor Marker Control 7 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

10 8 UROLOG PSA 0123 CFDA FDA 510K Cleared Prostate-specific antigen (PSA), also known as gamma-seminoprotein or kallikrein-3 (KLK3), is a glycoprotein enzyme encoded in humans by the KLK3 gene. PSA is a member of the kallikrein-related peptidase family and is secreted by the epithelial cells of the prostate gland. PSA is produced for the ejaculate, where it liquefies semen in the seminal coagulum and allows sperm to swim freely. It is also believed to be instrumental in dissolving cervical mucus, allowing the entry of sperm into the uterus. Testosterone FDA 510K Cleared Testosterone is a steroid hormone from the androgen group and is found in humans and other vertebrates. In humans and other mammals, testosterone is secreted primarily by the testicles of males and, to a lesser extent, the ovaries of females. Small amounts are also secreted by the adrenal glands. It is the principal male sex hormone and an anabolic steroid. Cat No Product name AMR Specimen volume LOD Time to result Package Storage FRPS 025 FRTE 020 FREND PSA Plus FREND Testosterone 0.05 ~ ng/ml 0.20ng/mL ~ 15.00ng/mL Serum/Plasma (Lithium heparin/ EDTA) Serum/Plasma (Lithium heparin/ EDTA) 35 μl 0.05 ng/ml Pretreatment : Specimen 70μL Cartridge loading : 35μL 0.20ng/mL Cartridge reaction : < 3 minutes Pretreatment : 5 minutes Cartridge reaction : < 3 minutes 25 tests 20 tests 2 ~ 8 C (35 ~ 46 F) 2 ~ 8 C (35 ~ 46 F)

11 Global Top Digital POCT Creator THROID TSH Thyroid-stimulating hormone (also known as thyrotropin, thyrotropic hormone, TSH, or htsh for human TSH) is a pituitary hormone that stimulates the thyroid gland to produce thyroxine (T4), and then triiodothyronine (T3) which stimulates the metabolism of almost every tissue in the body. It is a glycoprotein hormone synthesized and secreted by thyrotrope cells in the anterior pituitary gland, which regulates the endocrine function of the thyroid. Free T4 A hormone that is made by the thyroid gland and is one of the most important thyroid hormones. Four iodine molecules are attached to the molecular structure of thyroxine. Along with the more powerful thyroid hormone triiodothyronine (T3), thyroxine affects almost every process in the body, including body temperature, growth, and heart rate. Also known as T4 Total T3 Triiodothyronine, also known as T3, is a thyroid hormone. It affects almost every physiological process in the body, including growth and development, metabolism, body temperature, and heart rate. Cat No Product name AMR Specimen volume LOD Time to result Package Storage FRTS 025 FRT4 020 FRTT3 020 FRTD 020 FREND TSH FREND Free T4 FREND Total T3 FREND Thyroid Duo (TSH/FreeT4) 0.06 ~ mlu/l 0.40 ~ 6.00 ng/dl 0.25 ~ 8.00 ng/ml TSH: 0.06 ~ 25.00mIU/L FreeT4: 0.40~6.00ng/dL FDA 510K Cleared FDA 510K Cleared Serum and Plasma (Lithium heparin) Serum and Plasma (Lithium heparin) Serum and Plasma (Lithium heparin) Serum and Plasma (Lithium heparin) Cartridge loading : 35μL Pretreatment : Specimen 70μL Cartridge loading : 35μL Pretreatment : Specimen 70μL Cartridge loading : 35μL Pretreatment : Specimen 70μL Cartridge loading : 35μL 0.06 mlu/l ng/dl 0.25 ng/ml TSH: 0.06mIU/L FreeT4: 0.40ng/dL Cartridge reaction : < 3 minutes Pretreatment : 5 minutes Cartridge reaction : < 3 minutes Pretreatment : 5 minutes Cartridge reaction : < 3 minutes Pretreatment : 5 minutes Cartridge reaction : < 3 minutes 25 tests 20 tests 20 tests 20 tests 2 ~ 8 C (35 ~ 46 F) 2 ~ 8 C (35 ~ 46 F) 2 ~ 8 C (35 ~ 46 F) 2 ~ 8 C (35 ~ 46 F) 9 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

12 10 CARDIAC Cardiac Triple Cardiac Triple test measures the level of CK-MB, Troponin I Myoglobin to detect and monitor heart attack or injury to heart muscle. It is fast and accurate quantitative in vitro diagnostic of the protein in human serum or plasma based on the lab-on-a-chip technology. BNP CFDA Brain natriuretic peptide or B-type natriuretic peptide (BNP) (also ventricular natriuretic peptide) is a 32-amino acid polypeptide secreted by the ventricles of the heart in response to excessive stretching of heart muscle cells (cardiomyocytes). The release of BNP is modulated by calcium ions. BNP is named as such because it was originally identified in extracts of porcine brain, although in humans it is produced mainly in the cardiac ventricles. Troponin I Troponin I is a part of the troponin complex. It binds to actin in thin myofilaments to hold the actin-tropomyosin complex in place. Because of it, myosin cannot bind actin in relaxed muscle. When calcium binds to the Troponin C it causes conformational changes which lead to dislocation of troponin I and finally tropomyosin leaves the binding site for myosin on actin leading to contraction of muscle. The letter I is given due to its inhibitory character. Cat No Product name AMR Specimen volume LOD Time to result Package Storage FRCT 025 FRBN 025 FRTI 025 FREND Cardiac Triple FREND BNP FREND Troponin I Myoglobin : 5.00 ~ ng/ml Troponin I : 0.05 ~ ng/ml CK-MB : 1.00 ~ ng/ml Plasma(EDTA) ~ ng/ml Plasma(EDTA) 0.05 ~ ng/ml Plasma(EDTA) Cartridge loading : 35μL Cartridge loading : 35μL Cartridge loading : 35 μl Myoglobin : 5.00 ng/ml Troponin I : 0.05 ng/ml CK-MB : 1.00 ng/ml ng/ml Troponin I : 0.05 ng/ml Cartridge reaction : < 3 minutes Cartridge reaction : < 3 minutes Cartridge reaction : < 3 minutes 25 tests 25 tests 25 tests 2 ~ 8 C (35 ~ 46 F) 2 ~ 8 C (35 ~ 46 F) 2 ~ 8 C (35 ~ 46 F)

13 Global Top Digital POCT Creator PROCALCITONIN, VITAMIN D Procalcitonin Procalcitonin (PCT) is a peptide precursor of the hormone calcitonin, the latter being involved with calcium homeostasis. It is composed of 116 amino acids and is produced by parafollicular cells (C cells) of the thyroid and by the neuroendocrine cells of the lung and the intestine. Vitamin D Vitamin D is a steroid hormone involved in the active intestinal absorption of calcium and in the regulation of its homeostasis. It plays a vital role in the formation and maintenance of strong, healthy bone. vitamin D deficiency has long been associated with rickets in children and osteomalacia in adults; and long term insufficiency of calcium and vitamin D leads to osteoporosis. Additionally, in recent years, vitamin D has become an assay of general health status, and there nave been multiple publications linking vitamin D deficiency to several disease states, such as cancer, cardiovascular disease, diabetes, and autoimmune disease. Cat No Product name AMR Specimen volume LOD Time to result Package Storage FRPC 025 FREND PCT 0.07 ~ ng/ml Serum and Plasma (Citrate/Lithium heparin/edta) Cartridge loading : 35μL 0.07 ng/ml Cartridge reaction : < 3 minutes 25 tests 2 ~ 8 C (35 ~ 46 F) Cat No Product name AMR Specimen volume LOD Time to result Package Storage FRVD 020 FRVDAP 020 FREND Vitamin D (Heating Block) FREND Vitamin D (AP) ~ ng/ml ~ ng/ml Serum and Plasma (Citrate/Lithium heparin/edta) Serum and Plasma (Citrate/Lithium heparin/edta) FDA 510K Cleared Pretreatment : Specimen 70μL Cartridge loading : 35μL Pretreatment : Specimen 70μL Cartridge loading : 35μL ng/ml ng/ml Pretreatment : 30 minutes Cartridge reaction : < 3 minutes Pretreatment : 15 minutes Cartridge reaction : < 3 minutes 20 tests 20 tests 2 ~ 8 C (35 ~ 46 F) 2 ~ 8 C (35 ~ 46 F) 11 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

14 12 Bright field Utilized Direct Diagnostic Immunoassay analyzer People usually diagnose diseases using Rapid Test which is accurate and easy to use. However it is difficult to decide the unclear test line is positive or negative. BUDDI TM will help the problem. BUDDI TM is an image analyzer that evaluates the line signal intensities of analyte and control line on the test device. Now, you can clarify decision making with BUDDI TM SMART CONNECTIVIT Cat. No Product Type (pack size) Specimen Shelf life B10 BUDDI TM BUDDI TM Influenza A&B Card (20T/Kit) Nasal swab/ Throat swab 24M TEST ITEM Infectious Disease : Influenza A & B Comming Soon Infectious Disease : Strep A, RSV Cardiac disease : H-FABP/ Troponin I Duo SPECIFICATION Dimension(mm) 166mm x 202 mm x 205 mm (W x L x H) Weight 2 Kg Electrical rating Voltage: AC100 ~ 240 V, Current: 1.7 A, Frequency: 50 ~ 60 Hz Electric input Voltage: DC 12 V, Current: 5 A Battery Up-to 4 hours (Built in battery) Instrument reading time 20 seconds Operating Condition Temperature: 15 C ~ 30 C, Humidity: 10% ~ 80% Patient Test result Storage 3,000 tests

15 Global Top Digital POCT Creator ADVANTAGE of BUDDI TM Smart connectivity (EMR/ LIS & Wi-Fi) PREPARATION of RAPID TEST 1 - Extract specimen using throat swab or nasal swab. 4 - Add 5 drops (100uL) into the sample well of the test device. - Reaction time is 8 min. BUDDI TM PROCEDURES Press the TEST button on the main screen. Easy test procedures Qualitative result Compact design (user friendly touch screen interface) 2 - Insert the swab into the collection tube containing extraction solution. - Swirl the swab, fully. 5 - Read the result using BUDDI TM - Click the device slot. - Load the test device on the slot and gently close the tray. 3 - Type the patient ID / user ID (optional). - Press the OK button 3 - Close the cap and break the tube cap tip. 4 - When the test is done, the results are displayed. 13 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

16 14 FEATURES of RAPID TEST One step Rapid Test Rapid (same day results possible) Accurate Easy to use and easy to interpret the result No instrument required Cost-effective Shelf life up to 18~24 months without refrigeration Strip Card Multi

17 Global Top Digital POCT Creator BIOTRACER TM ORDER INFORMATION Item Hepatitis Infectious Disease Description HBsAg Anti-HBs HCV HIV 1/2 HIV 1/2/O Syphilis HSV-2 Influenza A&B H. Pylori H. Pylori Ag TB Malaria P.f Malaria P.f/PAN Malaria P.f/P.v Malaria Ab P.f/P.v Malaria Ab/Typhoid Ab Item Infectious Disease Tumor Marker Fertility Hormone Acute Myocardial Infarction Description Dengue Combo Dengue IgG/IgM Dengue NS1 Ag Norovirus Rotavirus Adenovirus Rota/Adeno Noro/Rota/Adeno AFP PSA CEA FOB hcg LH Troponin I Cardiac 3 in 1 15 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

18 16 HEPATITIS Hepatitis is a medical condition defined by the inflammation of the liver and characterized by the presence of inflammatory cells in the tissue of the organ. Hepatitis may occur with limited or no symptoms, but often leads to jaundice, poor appetite, and malaise. Hepatitis is acute when it lasts less than six months and chronic when it persists longer. Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus. The virus is transmitted through contact with the blood or other body fluids of an infected person. Hepatitis C is spread primarily by blood-to-blood contact associated with intravenous drug use, poorly sterilized medical equipment, and transfusions. An estimated million people worldwide are infected with hepatitis C.

19 Global Top Digital POCT Creator HBsAg/Anti-HBs Rapid Card HCV Rapid Card 17 HBsAg : Hepatitis B virus Surface Antigen Test Anti-HBs : Hepatitis B virus Surface Antibody Test Analytical sensitivity : 1ng/ml of HBsAg, 30mlU/ml of Anti-HBs Specimen : Serum or Plasma 100 μl Reading Time : min HBsAg Card (30T/Kit) Serum/ Plasma 18M 2~30 C HBsAg Multi (10Tx10/Kit) Serum/ Plasma 18M 2~30 C Anti-HBs Card (30T/Kit) Serum/ Plasma 18M 2~30 C Anti-HBs Multi (10Tx10/Kit) Serum/ Plasma 18M 2~30 C Clinical Performance HBsAg Rapid Card BioTracer TM HBsAg Rapid Card Total Positive Negative Positive ELISA Negative Total Sensitivity : 99.4%, Specificity : 99.9% Anti-HBs Rapid Card BioTracer TM Anti-HBs Rapid Card Total Positive Negative Positive ELISA Negative Total Sensitivity : 99.2%, Specificity : 99.9% Hepatitis C virus Antibody Test Applied highly purified recombinant proteins : Core, NS3, NS4, NS5 Specimen : Serum, Plasma or Whole Blood 10μl Sample diluent: 4-5 drops (80-100μl) Reading Time :10-15 min HCV Card (30T/Kit) Serum/ Plasma/Whole Blood 18M 1~30 C HCV Multi (10Tx10/Kit) Serum/ Plasma/Whole Blood 18M 1~30 C Clinical Performance BioTracer TM HCV Rapid Card Total Positive Negative Positive ELISA Negative Total Sensitivity : 98.7%, Specificity : 99% FREND TM SSTEM BUDDI TM BioTracer TM ADAM

20 18 INFECTIOUS DISEASES Infectious diseases are disorders caused by organisms such as bacteria, viruses, fungi or parasites. Many organisms live in and on our bodies. They re normally harmless or even helpful, but under certain conditions, some organisms may cause disease. Some infectious diseases can be passed from person to person. Some are transmitted by bites from insects or animals. And others are acquired by ingesting contaminated food or water or being exposed to organisms in the environment. Signs and symptoms vary depending on the organism causing the infection, but often include fever and fatigue. BioTracer TM infectious disease products are HIV 1/2, HSV-2, Influenza A&B, H.pylori, Dengue, TB, Syphilis, Malaria and Typhoid.

21 Global Top Digital POCT Creator Respiratory Infection Influenza A&B Test TB Rapid Card Influenza type A and B with separate test line at one time Sensitivity : Flu A 95.1% Flu B 95.92%, Specificity : 99.9% Specimen : Nasal swab or Throat swab Reading Time : 15 min (Strip), 10 min (Card) Influenza A&B Influenza A&B Mycobacterium tuberculosis Antibody test Sensitivity : >82.5%, Specificity : 92.7% Specimen : Serum, Plasma 3 drops (120μl) Reading Time : min Strip (20T/Kit) Nasal swab/throat swab 24M 2~30 C Card (20T/Kit) Nasal swab/throat swab 24M 2~30 C TB Card (30T/Kit) Serum/ Plasma 24M 2~30 C 19 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

22 20 Acute febrile illness Malaria Rapid Card Malaria P.f Rapid Card Malaria P.f/ PAN Rapid Card Malaria P.f/P.v Rapid Card Malaria Ab P.f/P.v Malaria P.falciparum (HRP-II )and the other plasmodium (pldh) Antigen and Antibody Test Malaria P.f/ PAN, P.f/P.v, P.f P.f/PAN Sensitivity: 99.6% (P.f ) 95.9% (Non-P.f ) P.f/P.v Sensitivity: 99.6% (P.f ) 98% (P.v) Specificity: 99.3% Specimen: Whole blood 5μl using loop Sample diluent: 4 drops (120μl) Reading Time: 20 min Malaria Ab P.f/P.v Sensitivity: 90% Specificity: 99.1% Specimen: : Serum, Plasma 10μl or Whole Blood 20μl Sample diluent: 4 drops Reading Time: 15~20 min Malaria P.f/PAN Malaria P.f/P.v Card (30T/Kit) Whole Blood 24M 1~40 C Card (30T/Kit) Whole Blood 24M 1~40 C Malaria P.f Card (30T/Kit) Whole Blood 24M 1~40 C Malaria Ab P.f/P.v Card (30T/Kit) Serum/ Plasma/Whole Blood 24M 1~30 C Dengue Rapid Card Dengue Combo Rapid Card Dengue IgG/IgM Rapid Card Dengue NS1 Ag Rapid Card Dengue virus (DEN1, DEN2, DEN3 and DEN4) NS1 antigen and IgG/IgM antibody test IgG/IgM Sensitivity: 91.3% Specificity : 92% Specimen : Serum, Plasma or Whole blood 5μl Sample diluent: 4 drops (120μl) NS1 Sensitivity: 93.3% Specificity : 98.5% Specimen : Serum, Plasma or Whole blood 3drops (100μl) Reading Time : 15~20 min Dengue Combo Dengue IgG/IgM Dengue NS1 Ag Card (10T/Kit) Serum/ Plasma/Whole Blood 24M 1~30 C Card (30T/Kit) Serum/ Plasma/Whole Blood 24M 1~30 C Card (30T/Kit) Serum/ Plasma/Whole Blood 24M 1~30 C Malaria Ab/ Typhoid Ab Rapid Card Antibody of Typoid(Salmonella typhi) and Malaria(P.falciparum, P.vivax) Test at one time Malaria- Sensitivity : 99.1 %, Specificity : 99.4% Typhoid- Sensitivity : 98 %, Specificity : 97.9% Specimen : Serum, Plasma 10μl or Whole Blood 20μl Sample diluent: 4 drops Reading time: 15~20 min Malaria Ab/ Typhoid Ab Card (30T/Kit) Serum/ Plasma/Whole Blood 24M 1~30 C

23 Global Top Digital POCT Creator Sexually Transmitted Infection HIV 1/2 Rapid Card HIV 1/2 Rapid Card HIV 1/2/O Rapid Card HIV 1/2 Rapid Card Syphilis Rapid Card HSV-2 Rapid Card HIV(Human Immunodeficiency Virus) antibody Test Applied highly purified HIV recombinant proteins : p24, gp41, gp36 and type O (HIV 1/2/O) Detect HIV type 1 and type 2 with separate test lines at one time Sensitivity : 99.9%, Specificity :99.7% Specimen : Serum, Plasma 10μl or Whole Blood 20μl Sample diluent : 4 drops (100µl) Reading Time : 5-20 min HIV 1/2 Card (30T/Kit) Serum/ Plasma/Whole Blood 18M 1~30 C HIV 1/2 Multi (10Tx10/Kit) Serum/ Plasma/Whole Blood 18M 1~30 C HIV 1/2/O Card (30T/Kit) Serum/ Plasma/Whole Blood 24M 1~30 C Treponema pallidum Antibody Test Sensitivity : 99.4%, Specificity :99.5% Specimen : Serum, Plasma 10μl or Whole Blood 20μl Sample diluent: 4 drops Reading Time : 5~20 min Syphilis Card (30T/Kit) Serum/ Plasma/Whole Blood 24M 1~30 C Syphilis Multi (10Tx10/Kit) Serum/ Plasma/Whole Blood 24M 1~30 C Herpes Simplex Virus type 2 Antibody Test Sensitivity : 97.2%, Specificity : 97.6% Specimen : Serum, Plasma 10μl or Whole Blood 20μl Sample diluent: 3 drops (80-120μl) Reading Time : 10~20 min HSV-2 Card (10T/Kit) Serum/ Plasma/Whole Blood 18M 4~30 C 21 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

24 22 Gastrointestinal Infection H.pylori Rapid Card H.pylori Rapid Card H.pylori Ag Rapid Card Helicobacter pylori Antigen and Antibody Test H.pylori (Ab) Sensitivity : 99.9 % Specificity : 97% Specimen : Serum, Plasma or Whole blood 3 drops ( μl) Reading Time : 10 min H.Pylori Ag Sensitivity : 99.1 % Specificity : 98.3% Specimen : Human stool Sample tube: 5-6 drops (120μl) Reading Time : 15 min H.pylori Card (30T/Kit) Serum/ Plasma/Whole Blood 24M 1~30 C H.pylori Ag Card (20T/Kit) Stool 24M 1~30 C Norovirus Rapid Test Detect Norovirus in human stool Specimen : Human stool Sample tube: 5 drops (150μl) Sensitivity : 85.1%, Specificity : 99.3% Reading Time : 15 min Norovirus Card (20T/Kit) Stool 24M 1~30 C Noro/Rota/Adeno Combi Detect Noro/Rota/Adenovirus in human stool Specimen : Human stool Sample tube: 5 drops (150μl) Sensitivity Noro: 86%, Rota: 98.9%, Adeno: >99.9% Specificity Noro: 99%, Rota: 99.1%, Adeno: 99.1% Reading Time : 15 min Noro/Rota/ Adeno Card (20T/Kit) Stool 24M 1~30 C

25 Global Top Digital POCT Creator Adenovirus Rapid Card Rota/Adeno Rapid Card Rotavirus Rapid Card Detect Adenovirus in human stool Specimen : Human stool Sample tube: 5 drops (150μl) Sensitivity : >99.9%, Specificity : >99.9% Reading Time : min Adenovirus Card (20T/Kit) Stool 24M 1~30 C Detect Group A Rotavirus & Adenovirus Specimen : Human stool Sample tube: 5 drops (150μl) Rotavirus - Sensitivity : 98.9%, Specificity: 99.1% Adenovirus - Sensitivity : >99.9%, Specificity: >99.9% Reading Time: min Rota/ Adeno Detect Group A Rotavirus Specimen : Human stool Sample tube: 5 drops (150μl) Sensitivity : 98.9%, Specificity: 99.1% Reading Time : min Card (20T/Kit) Stool 24M 1~30 C Rotavirus Card (20T/Kit) Stool 24M 1~30 C 23 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

26 24 TUMOR MARKER A tumor marker is a biomarker found in the blood, urine, or body tissues that can be elevated in cancer, among other tissue types. There are many different tumor markers, each indicative of a particular disease process, and they are used in oncology to help detect the presence of cancer. An elevated level of a tumor marker can indicate cancer. AFP is used as a tumor marker to help detect and diagnose cancers of the liver. PSA is a protein produced by cells of the prostate gland. The blood level of PSA is often elevated in men with prostate cancer. CEA test measures certain kinds of cancers, especially cancer of the large intestine (colon and rectal cancer). FOB test checks for hidden (occult) blood in the stool. The test does not directly detect colon cancer but is often used in clinical screening for that disease.

27 Global Top Digital POCT Creator FOB Rapid Card AFP/PSA/CEA Rapid Card 25 Screening test for Fecal Occult Blood Early diagnosis for Colon Cancer No Cross reactivity - Bovine Hemoglobin, Swine hemoglobin, Horse hemoglobin, Bililrubin, Bovine serum albumin Vitamin C Analytical sensitivity : 50ng/ml of FOB Specimen : Stool Sample tube: 3 drops (100μl) Reading Time : 5~10 min FOB Multi (50T/Kit) Stool 24M 2~30 C Clinical Performance BioTracer TM FOB Rapid Card Total Positive Negative Positive ELISA Negative Total Sensitivity : 99%, Specificity : 99.9% AFP : Alpha-Feto Protein Test to detect Liver Cancer PSA : Prostate-specific Antigen Test to detect Prostate Cancer CEA : Carcinoembryonic Antigen Test to detect Colorectal Cancer Specimen : Serum or plasma 100μl Reading Time : 20 min AFP PSA CEA Analytical Sensitivity 20ng/mI 3ng/mI 5ng/mI Sensitivity 99.9% 99.9% 99.9% Specificity 98.8% 99.4% 98.8% AFP Card (30T/Kit) Serum/ Plasma 18M 2~30 C AFP Multi (10Tx10/Kit) Serum/ Plasma 18M 2~30 C PSA Card (30T/Kit) Serum/ Plasma 18M 2~30 C CEA Card (30T/Kit) Serum/ Plasma 24M 2~30 C FREND TM SSTEM BUDDI TM BioTracer TM ADAM

28 26 FERTILIT HORMONE Men and women have hormonal cycles which determine both when a woman can achieve pregnancy and when a man is most virile. Pregnancy tests are usually simple urine tests that show if a woman is pregnant. They test for a hormone called human chorionic gonadotropin (HCG). HCG is released when a fertilized egg attaches to the lining of the uterus. HCG is only found in a woman s body if she is pregnant. LH(Luteinizing Hormone) helps regulate the menstrual cycle and egg production (ovulation). LH test help predict the time of ovulation and peak fertility.

29 Global Top Digital POCT Creator hcg Rapid Card/ LH Rapid Card/ 27 Pregnancy Test Analytical sensitivity: 25mlU/ml of hcg Sensitivity : 99.9%, Specificity: 99.9% Specimen : Urine Sample volume of Card type: 3 drops (100μl) Reading Time : 3~5 min No cross reactivity : hlh(300mlu/ml), hfsh(1,000mlu/ml), and htsh(1,000μlu/ml) hcg Card (25T/Kit) Urine 24M 1~30 C hcg Midstream (1T/Kit) Urine 24M 1~30 C Ovulation Test to detect Luteinizing Hormone in Urine Analytical sensitivity : 40mlU/ml of LH Sensitivity : 99.9%, Specificity: 99.9% Specimen : Urine 3 drops (100μl) Reading Time : 5~10 min No cross reactivity : hcg(1,000mlu/ml), hfsh(1,000mlu/ml), and htsh(1,000μlu/ml) LH Card (25T/Kit) Urine 18M 2~30 C LH Midstream (1T/Kit) Urine 24M 1~30 C FREND TM SSTEM BUDDI TM BioTracer TM ADAM

30 28 ACUTE MOCARDIAL INFARCTION Acute myocardial infarction (AMI), commonly known as a heart attack, occurs when blood flow stops to a part of the heart causing damage to the heart muscle. The most common symptom is chest pain or discomfort which may travel into the shoulder, arm, back, neck, or jaw. Cardiac Triple test measures the level of Myoglobin, CK-MB, Troponin I to detect and monitor heart attack or injury to heart muscle. Myoglobin has the advantage of responding very rapidly, rising and falling earlier than CK-MB or troponin. Creatine Kinase (CK-MB) test is relatively specific when skeletal muscle damage is not present. Troponin test is the most sensitive and specific test for myocardial damage.

31 Global Top Digital POCT Creator Troponin I Rapid Card/ Cardiac 3 in 1 Point of care test at Emergency Room No cross reactivity Analytical Sensitivity Troponin I: 1ng/mI CK-MB: 5ng/mI Myoglobin: 70ng/mI Specimen : Serum, Plasma or Whole Blood 120μl Reading Time : 15~20 min Troponin I Card (10T/Kit) Serum/Plasma/Whole Blood 18M 1~30 C Cardiac 3 in 1 (ctni/ck-mb/myo) Card (10T/Kit) Serum/Plasma/Whole Blood 24M 2~30 C Clinical Performance Troponin I ELISA BioTracer TM Cardiac 3 in 1 Positive Negative Total Positive Negative Total Sensitivity: 93.8% Specificity: 98.8% CK-MB BioTracer TM Cardiac 3 in 1 Total Positive Negative Positive ELISA Negative Total Sensitivity : 98.5%, Specificity : 97.3% Myoglobin BioTracer TM Cardiac 3 in 1 Total Positive Negative Positive ELISA Negative Total Sensitivity : 97.4%, Specificity : 98.8% 29 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

32 30 ELISA

33 Global Top Digital POCT Creator Norovirus / Rotavirus / Adenovirus ELISA (Research Use Only) Enzyme immunoassay for the qualitative detection of Norovirus, Rotavirus, Adenovirus in human fecal specimen Specimen: Human stool Sensitivity & Specificity Norovirus: 90.9%, >99.9% Rotavirus: 99.1%, 99.2% Adenovirus: >99.9%, >99.9% Test Procedure <Norovirus> Anti-human Norovirus coated plate <Rotavirus & Adenovirus> Anti-human Rota(Adeno) virus coated plate Conjugate 1 Add the streptavidin peroxidase conjugate (conjugate 2) Incubation : 60min at 20~30 C Conjugate 1 Conjugate 1 Add the stool sample and monoclonal Rota(Adeno) virus antibody enzyme conjugate Incubation : 60min at 20~30 C Conjugate 2 Conjugate 1 Add the sample and biotinylated monoclonal anti-norovirus antibodies (conjugate 1) Incubation : 60min at 20~30 C TMB substrate Incubation : 15min at 20~30 C Conjugate 2 Conjugate 1 TMB substrate Incubation : 15min at 20~30 C Norovirus Microplate (96T/Kit) Stool 12M 2~8 C Rotavirus Microplate (96T/Kit) Stool 12M 2~8 C Adenovirus Microplate (96T/Kit) Stool 12M 2~8 C Conjugate 2 Conjugate 1 Conjugate 2 Conjugate 1 Conjugate 2 Conjugate 1 Conjugate 2 Conjugate 1 31 FREND TM SSTEM BUDDI TM BioTracer TM ADAM

34 32 ADAM TM -rwbc FDA 510K Cleared New standard of automatic residual leukocyte counting 3 minutes you can count on! No more manual counting! ADAM TM -rwbc ADAM TM -rwbc is an analytical device for counting the number of residual white blood cells (rwbcs) in leukoreduced blood products. The device ensures the number of rwbcs meets the standards used to minimize complications associated with the transfusions performed in hospitals. ADAM TM - rwbc uses propidium iodide (PI) staining. The automatic X stage of ADAM TM -rwbc captures over 200 images and maximizes the accuracy of analytic. By averaging results, ADAM TM -rwbc produces accurate counting results in the analysis of low concentration of leukoreduced blood products. In combination with a disposable microfluidic slide, the operation of ADAM TM -rwbc is extremely simple and cost-effective. Warm-up time and messy cleaning is no longer necessary. The disposable slide also greatly reduces the risk of the exposure to hazardous blood samples or virus-infected cells. New technology behind the accuracy of ADAM TM -rwbc ADAM TM -rwbc is a precise, automated optical system capable of fluorescent image analysis. After samples are stained with propidium iodide (PI) which intercalates the DNA to stain the nucleus of the target cells, fluorescent images are automatically taken. ADAM TM -rwbc takes 203 images by the movement of the automatic X- stage. The obtained images are processed by image analysis software. All procedures are automated once the sample loaded slide is inserted into the device. LED light source Sensitive CCD detection Precision automatic stage Automatic image analysis Automatic focusing Microfluidic r-slide r-slide Unlike conventional cell counters, ADAM TM -rwbc doesn t require routine cleaning and maintenance. Each r-slide is designed for single use. Pumping, cleansing and waste bottles are not necessary for the ADAM TM -rwbc. Also, the risk of exposure to the potential hazardous blood samples is greatly reduced with the use of the disposable r-slide. Each r-slide is manufactured and validated in a state-of-the-art manufacturing facility for accuracy and precision. Disposables rwbc Kit (Cat No. AD1K-050) [ r-slide, r-solution and Standard Bead(50 Tests) ] r-solution / vol. 25 ml (Cat No. RDR-50) standard bead / vol. 7 ml (Cat No. ADST-001) r-slide (Cat no. RDS-50)

35 Global Top Digital POCT Creator ADAMII TM -CD34 A benchtop fluorescent CD34 counting analyzer Revolutionary new way to count CD34 ADAMII TM (CD34 cells/ µl) ADAMII TM -CD34 ADAMII TM -CD34 is a bench top fluorescent CD34 counting analyzer that can be used in hospital and research laboratory. It has 4-channel (Bright, ellow (PE), Red (PerCP) and Green (FITC)) light sources and perform assays for CD34+ / CD45+ cells as well as cell viability (CD34 and CD45) simultaneously. The automatic X--Z stage captures maximum 136 images and increases the accuracy of analysis. The obtained images are processed by image analysis software integrated inside the system. All procedures are automatic once the stained sample has been dropped to the disposable chip. Features A benchtop fluorescence CD34 counting analyzer Can be used in hospital and research laboratory Visualize: Quantitative results with visual confirmation Quantify fluorescent CD34 stem cells-antibody Simple and easy to use Pipetting sample Add staining with antibody and wait for 20 min Add lysis buffer and wait for 10 min Highly accurate analysis ADAMII TM VS. Flow cytometry (Mobilized PB) Load sample Total 16 Mobilized PB samples were used to compare ADAMII TM and flow cytometry. Linear regression analysis revealed a close correlation between the data for the absolute number of CD34+ and its cell fractions (%) obtained with the ADAMII and those obtained with thethe flow cytometry for PBSCs (Absolute number of CD34, R 2 = 0.97; CD34+ fractions (%), R 2 = 0.99). Insert slide ADAMII TM VS. Flow cytometry (PBSC) Get result Total 18 PBSC samples were used to compare ADAMII TM and flow cytometry. Linear regression analysis revealed a close correlation between the data for the absolute number of CD34+ and its cell fractions (%) obtained with the ADAMII and those obtained with the flow cytometry for PBSCs (Absolute number of CD34, R 2 = 0.99; CD34+ fractions (%), R 2 = 0.98). A: Total CD34 (Cells/µL) B: Total CD34 (%) A: Viable CD34 (Cells/µL) B: Viable CD34 (%) y=1.0172x y = x y = x y = x R² = R² = R² = R² = Flow cytometry (CD34 CD45 Flow cytometry (CD34 cells / µl) %) / Flow cytometry (CD34 cells/µl) Flow cytometry (CD34 %)/CD45 ADAMII TM (CD34 %)/ CD45 ADAMII TM (CD34 cells/ µl) ADAMII TM (CD34 %)/ CD FREND TM SSTEM BUDDI TM BioTracer TM ADAM The correlation for CD34 cell counts between the ADAMII TM and the flow cytometry (A) Absolute number of CD34+ cells, (B) Percentage of CD34+ cells The correlation for CD34 cell counts between the ADAMII TM and the flow cytometry (A) Absolute number of CD34+ cells, (B) Percentage of CD34+ cells

36 NESCT-ALL-001E(V.2.0)