What is FREND? Summary of Advantages The Principle of Reaction The Technology

2. Index What is FREND? Summary of Advantages The Principle of Reaction The Technology Test for Prostate Specific Antigen Performance Characteristics How to Use FREND PSA Kit Correlation with Commercial PSA Equipments Assay Table in 2010 Specifications

3. What is FREND ? Fluorescence Response Enhanced Novel Diagnostics • The FREND is designed by LOC (Lab-on-a-chip) based technology • For RAPID and QUANTITATIVE immunoassay using small sample volume • Innovative platform developed

4. Summary of Advantages Fast: Loading Reading Result, Test in an Instant (5min) Accurate : Ensure the Accuracy (CV 5 ~ 7%) Compact : Small & Light Weight Sample : Plasma/Serum 30㎕

5. The Principle of Reaction Conjugate Zone Sample Inlet Test Zone Reference Zone Sample buffer & conjugate buffer are treated on the settled position and dried. Antibody detector coupled Fluorescence Particle Dark Red F. P. Plasma / Serum PSA 5min Biotinylated Capture Antibody B Avidin Slide Test zone

6. The Technology MEMS for Device – Membrane Free Revolutionary platform ; Sample, reaction and absorption pads have been replaced by several micro-fluidic components which have been optimized for a FRENDTM device. Membrane-free technology ; No need for sample or conjugate pad

7. Test for Prostate Specific Antigen The Risk of Prostate Cancer • 192,280 patients were newly diagnosed • with prostate cancer*). • 27,360 patients died • due to prostate cancer*). • Worldwide, 670,000 men were newly • diagnosed with prostate cancer in2008**). • Prostate cancer has the second highest • mortality rate, after lung cancer. • One out of six men may be diagnosed with • prostate cancer in their lifetime. • One out of 35 men may losetheir life • due to prostate cancer. • *)The American Cancer Society (ACS), 2009 • **)European Randomized Study of Screening for • Prostate Cancer (ERSP), 2008

8. Test for Prostate Specific Antigen • Prostate-Specific Antigen (PSA) is a tumor marker specific to the prostate • PSA takes a very important role in early diagnosis of prostate cancer • In general, less than 4ng/ml is regarded as the normal value of PSA • 30~35% men (PSA level is over 4ng/ml) may be diagnosed with prostate cancer • A PSA level over 10ng/ml has a 50% chance in a prostate cancer diagnosis. • The FDA has confirmedthat a PSA test is effective in the detection of prostate cancer • when used in combination with a digital rectal examination (DRE) in men aged 50 years or older***) • ***)National Cancer Institute

9. Performance Characteristics FRENDTM PSA Measurable Ranges: 0.5 ~ 60ng/mL Cut-Off : PSA 4ng/mL Reaction Time: about 5min Sample Volume: Plasma/Serum 30㎕ Sensitivity : 99% CV(coefficient of variation) : 5~7%

10. How to Use FRENDTM PSA Step1. Step 2. Step 3. Loading Reading Result Display Quantitative Result on the Screen

11. Correlation with Commercial PSA Equipments FREND PSA con.(ng/㎖) FREND PSA con.(ng/㎖) Commercial equipment A(ng/㎖) Commercial equipment B(ng/㎖) The correlation of PSA determined by FRENDTM against Laboratory results R2 value is more than 0.94

12. Specifications PSA Kit Q.C device Mobile Printer Barcode Reader Front Side Back