OnSite FOB Rapid TestA specific and sensitive colorectal cancer screening test

• The third most common cancer worldwideo About 1.4 million new case (10% of all cancer) in 2012o About 96,830 new case and 50,310 deaths in U.S. in 2014

• More than 95% of CRC develop from untreated polyps

• Curable if found early

• Preventable by removing precancerous polyps

- Colon and rectum cancers world map-Death- WHO 2004

Colorectal Cancer (CRC)

Colorectal Cancer Screening Methods

Advantages of using the FOBT: • Relatively simple; No cleansing of the colon is necessary• Samples can be collected at home• Low cost compared to other CRC screening tests• Non invasive, do not cause bleeding or tearing of the colon’s lining• Suitable for large population-based screening

Screening Methods Test Interval ShortageFecal occult blood test (FOBT): Every 1-2 yr

Fecal DNA test Uncommon Specific equipmentFlexible sigmoidoscopy Every 5 ys Expensive; SpecialistDouble contrast barium enema (DCBE) Every 5 ys SpecialistCT , MRI Every 5 ys Expensive; SpecialistColonoscopy Every 10 ys Expensive; Specialist

The Colorectal Prevention Policy in USA

Screening for CRC (from at age 50 ys till 75 ys) by using:

• High-sensitivity, non invasive, fecal occult blood testing (FOBT)

• Invasive sigmoidoscopy or colonoscopy -recommend from US Preventive Services Task Force

Used to detect gastrointestinal disorders, such as:

• Cancer

• Polyps

• Colitis

• Diverticulitis

FOBT Indications

FOBT performed every 1-2 years in people over 50 can reduce

the number of deaths due to CRC by 15-33%.

Two Major Types of FOBT

Fecal Guaiac Test Fecal immunochemical test (iFOBT)

Principle Chemical test Immunochemical test

Detection Pseudo peroxidase activity of haem/Hb

Globin antigen in hHb

History An old method On the market in 90’s

Interpretation Color change, hard to interpret Clear, accurate reading

Specificity Poor, detect non hHb Highly specific for hHb

Sensitivity >90,000 ng/mL Adjustable, as low as 25 ng/mL

Accuracy <86% >= 95%

Dietary & drug affected

Yes No

specimens 3 required 1 is sufficient; 2 recommended

OnSite FOB Rapid Test - An Ideal iFOBT

25 tests each kit, contains

• 25 test individual devices

• 25 fecal extraction tubes

• 25 specimen ID labels

• 1 IFU

Key features• Simple procedure, clear result, no equipment needed, minimal training• Perform assay anywhere • 24 month shelf life • Room temperature storage

Collect specimen Shake vigorously 2 drops of sample 5-10 minutes

Perform Assay - Simple, Rapid Procedure

Protective cap

Only C line is developed Both C and T line are developed

Perform Assay - Clear, Easy-To-Read Result

Negative Positive

OnSite FOB Rapid Test

in comparison with other iFOBT on the market

The OnSite FOB Rapid Test has three levels of the analytical sensitivity to meet the needs from different market:

• 25 ng hHb/mL buffer

• 50 ng hHb/mL buffer

• 100 ng hHb/mL buffer

OnSite FOB Rapid Test Has Three Sensitivity Levels

A wider detection range by the OnSite FOB Rapid Test eliminates the risk of false negative results from specimens with a high concentration of hemoglobin.

Clinical Performance - Wider Detection Range

2 mg/mL buffer is the dose of hook effect by the most other iFOBTs

hHb Level OnSite IFOBT result

5 mg/mL hHb Weak positive

4 mg/mL hHb Clear positive

3 mg/mL hHb Clear positive

2 mg/mL hHb Clear positive

OnSite FOB Rapid Test

Leading iFOBT Positive Negative Total

Positive 47 1 48

Negative 1 126 127

Total 48 127 175

A total of 175 specimens were collected for the performance study. The OnSite FOB Rapid Test was compared side by side with a leading brand iFOBT marketed in U.S. and other regions. The results show that both tests have high degree of agreement.

Relative Sensitivity: 97.9%, Relative Specificity: 99.2%, Overall Agreement: 98.9%

Clinical Performance - High Accuracy

HemoglobinHb Concentration without Cross Reaction

OnSite FOB Rapid Test Other iFOBTBovine Hemoglobin 2 mg/mL 1 mg/mLChicken Hemoglobin 2 mg/mL 1 mg/mLFish Hemoglobin 2 mg/mL 1 mg/mLGoat Hemoglobin 2 mg/mL 1 mg/mLHorse Hemoglobin 2 mg/mL 1 mg/mLPork Hemoglobin 2 mg/mL 1 mg/mLSheep Hemoglobin 2 mg/mL 1 mg/mLRabbit Hemoglobin 2 mg/mL 1 mg/mLTurkey Hemoglobin 2 mg/mL 1 mg/mL

Hemoglobin from different species was added to negative specimens and weak positive specimens. The OnSite FOB Rapid Test displayed very low risk of cross reactivity compared to other iFOBT. So it has less possibility to cross react with sources of hemoglobin consumed by the patient as meat.

Clinical Performance - Specific to hHb

Substance Concentration OnSite FOB Rapid TestNegative Positive

Control N/A Negative PositiveAscorbic Acid 20 mg/dL Negative PositiveBilirubin 100 mg/dL Negative PositiveCaffeine 40 mg/dL Negative PositiveGlucose 2,000 mg/dL Negative PositiveIron (Fe3+/Fe2+)) 5 mg/mL Negative PositiveHorseradish Peroxidase 20 mg/mL Negative Positive

The OnSite FOB Rapid Test gives correct results with no interference from common medicine and dietary substances.

Clinical Performance - No Known Interference

Clinical Validation

Test Result Not Affected by Cooked/Uncooked Food

• Beef

• Chicken• Fish• Lamb• Pork• Turkey

• In addition, toilet bowl cleansers do

not interfere with the results of the OnSite FOB Rapid Test.

• Broccoli• Cabbage• Cantaloupe• Cauliflower• Horseradish • Parsnip• Red radish• Turnip

In clinical practice, it has been demonstrated that the test result won’t by affected by a wide range of cooked or uncooked food, and no restricting diet or medication is needed for three days before testing.

We provide the external controls to ensure the proper performance of the assay, particularly when:• A new operator uses the test kit, prior to performing test• A new lot of test kits is used• A new shipment of test kits is used• The storage temperature of the kit falls outside of 2-30C• The temperature of the test area falls outside of 15-30C• To verify a higher than expected frequency of positive/negative

results• To investigate the cause of repeated invalid results

Positivia FOB External Control

Assure Product Performance

OnSite FOB Rapid Test - the Right Choice for You

• Non-invasive screening test o Simple procedure, fast result, low cost, and minimal trainingo Perform test anywhere

• Three levels of the sensitivity meet different needso 25 ng hHb/mL buffero 50 ng hHb/mL buffero 100 ng hHb/mL buffer

• Wider detection range and specific to hHb

• 98.9% agreement with the leading iFOBT

• Positivia external FOB assay control is available

Contact Info.:10110 Mesa Rim Rd. San Diego, CA 92121 USAEmail Address: tech@ctkbiotech.com Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739

Technical Support

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