OnSite

FOB Rapid Test

A specific and sensitive colorectal cancer screening test

Colorectal Cancer (CRC)

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The third most common cancer worldwide

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About 1.4 million new case (10% of all cancer) in 2012

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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 Screening Methods

Screening Methods Fecal occult blood test (FOBT): Fecal DNA test Flexible sigmoidoscopy Double contrast barium enema (DCBE) CT , MRI Colonoscopy Test Interval Every 1-2 yr Uncommon Every 5 ys Every 5 ys Every 5 ys Every 10 ys Shortage Specific equipment Expensive; Specialist Specialist Expensive; Specialist Expensive; Specialist

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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

The Colorectal Prevention Policy in USA

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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

FOBT Indications

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Used to detect gastrointestinal disorders, such as: Cancer Polyps Colitis Diverticulitis

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

Principle Detection History Interpretation Specificity Sensitivity Accuracy Dietary & drug affected specimens <86% Yes Fecal Guaiac Test Chemical test Pseudo peroxidase activity of haem/Hb An old method Fecal immunochemical test (iFOBT) Immunochemical test Globin antigen in hHb On the market in 90’s Color change, hard to interpret Clear, accurate reading Poor, detect non hHb >90,000 ng/mL 3 required Highly specific for hHb Adjustable, as low as 25 ng/mL >= 95% No 1 is sufficient; 2 recommended

OnSite FOB Rapid Test - An Ideal iFOBT

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25 tests each kit, contains 25 test individual devices 25 fecal extraction tubes 25 specimen ID labels 1 IFU

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

Perform Assay - Simple, Rapid Procedure

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

Perform Assay - Clear, Easy-To-Read Result

Negative Positive

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

OnSite FOB Rapid Test

in comparison with other iFOBT on the market

OnSite FOB Rapid Test Has Three Sensitivity Levels The

OnSite

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

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25 ng hHb/mL buffer

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50 ng hHb/mL buffer

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100 ng hHb/mL buffer

Clinical Performance - Wider Detection Range

A wider detection range by the concentration of hemoglobin.

OnSite

FOB Rapid Test eliminates the risk of false negative results from specimens with a high hHb Level 5 mg/mL hHb 4 mg/mL hHb 3 mg/mL hHb 2 mg/mL hHb OnSite IFOBT result Weak positive Clear positive Clear positive Clear positive

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

Clinical Performance - High Accuracy

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.

Leading iFOBT Positive Negative Total OnSite FOB Rapid Test Positive

47 1 48

Negative

1 126 127

Total

48 127 175

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

Clinical Performance - Specific to hHb

Hemoglobin from different species was added to negative specimens and weak positive specimens. The by the patient as meat.

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 Hemoglobin Bovine Hemoglobin Chicken Hemoglobin Fish Hemoglobin Goat Hemoglobin Horse Hemoglobin Pork Hemoglobin Sheep Hemoglobin Rabbit Hemoglobin Turkey Hemoglobin Hb Concentration without Cross Reaction OnSite FOB Rapid Test

2 mg/mL 2 mg/mL 2 mg/mL 2 mg/mL 2 mg/mL 2 mg/mL 2 mg/mL 2 mg/mL 2 mg/mL

Other iFOBT

1 mg/mL 1 mg/mL 1 mg/mL 1 mg/mL 1 mg/mL 1 mg/mL 1 mg/mL 1 mg/mL 1 mg/mL

Clinical Performance - No Known Interference

The

OnSite

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

Substance Control Ascorbic Acid Bilirubin Caffeine Glucose Iron (Fe 3+/ Fe 2+) ) Horseradish Peroxidase Concentration

N/A 20 mg/dL 100 mg/dL 40 mg/dL 2,000 mg/dL 5 mg/mL 20 mg/mL

OnSite FOB Rapid Test Negative Positive

Negative Positive Negative Negative Positive Positive Negative Negative Negative Negative Positive Positive Positive Positive

Clinical Validation Test Result Not Affected by Cooked/Uncooked Food

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Beef Chicken Fish Lamb Pork Turkey

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Broccoli Cabbage Cantaloupe Cauliflower Horseradish Parsnip Red radish Turnip

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In addition, toilet bowl cleansers do not interfere with the results of the Rapid Test.

OnSite

FOB 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.

Positivia FOB External Control

Assure Product Performance

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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 2-30

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C The temperature of the test area falls outside of 15-30

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C To verify a higher than expected frequency of positive/negative results To investigate the cause of repeated invalid results

OnSite FOB Rapid Test - the Right Choice for You

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Non-invasive screening test

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Simple procedure, fast result, low cost, and minimal training

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Perform test anywhere

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Three levels of the sensitivity meet different needs

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25 ng hHb/mL buffer

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50 ng hHb/mL buffer 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

Technical Support

Contact Info.: 10110 Mesa Rim Rd. San Diego, CA 92121 USA Email Address: [email protected]

Telephone: 1 (858) 457-8698 Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY