OnSite FOB Rapid Test A specific and sensitive colorectal cancer screening test

The third most common cancer worldwide o About 1.4 million new case (10% of all cancer) in 2012 o 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 MethodsTest IntervalShortage Fecal occult blood test (FOBT):Every 1-2 yr Fecal DNA testUncommonSpecific equipment Flexible sigmoidoscopyEvery 5 ysExpensive; Specialist Double contrast barium enema (DCBE)Every 5 ysSpecialist CT, MRIEvery 5 ysExpensive; Specialist ColonoscopyEvery 10 ysExpensive; 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 TestFecal immunochemical test (iFOBT) PrincipleChemical testImmunochemical test DetectionPseudo peroxidase activity of haem/Hb Globin antigen in hHb HistoryAn old methodOn the market in 90’s InterpretationColor change, hard to interpretClear, accurate reading SpecificityPoor, detect non hHbHighly specific for hHb Sensitivity>90,000 ng/mLAdjustable, as low as 25 ng/mL Accuracy<86%>= 95% Dietary & drug affected YesNo specimens3 required1 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 developedBoth C and T line are developed Perform Assay - Clear, Easy-To-Read Result NegativePositive

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 LevelOnSite IFOBT result 5 mg/mL hHbWeak positive 4 mg/mL hHbClear positive 3 mg/mL hHbClear positive 2 mg/mL hHbClear positive

OnSite FOB Rapid Test Leading iFOBTPositiveNegativeTotal Positive47148 Negative Total 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

Hemoglobin Hb Concentration without Cross Reaction OnSite FOB Rapid TestOther iFOBT Bovine Hemoglobin2 mg/mL1 mg/mL Chicken Hemoglobin2 mg/mL1 mg/mL Fish Hemoglobin2 mg/mL1 mg/mL Goat Hemoglobin2 mg/mL1 mg/mL Horse Hemoglobin2 mg/mL1 mg/mL Pork Hemoglobin2 mg/mL1 mg/mL Sheep Hemoglobin2 mg/mL1 mg/mL Rabbit Hemoglobin2 mg/mL1 mg/mL Turkey Hemoglobin2 mg/mL1 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 Test NegativePositive ControlN/ANegativePositive Ascorbic Acid20 mg/dLNegativePositive Bilirubin100 mg/dLNegativePositive Caffeine40 mg/dLNegativePositive Glucose2,000 mg/dLNegativePositive Iron (Fe 3+/ Fe 2+) )5 mg/mLNegativePositive Horseradish Peroxidase20 mg/mLNegativePositive 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 2-30  C The temperature of the test area falls outside of  C 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 training o Perform test anywhere Three levels of the sensitivity meet different needs o 25 ng hHb/mL buffer o 50 ng hHb/mL buffer o 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.: Mesa Rim Rd. San Diego, CA USA Address: Telephone: 1 (858) Fax: 1 (858) Technical Support

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