Immunological Fecal Occult Blood Testing (iFOB)

BACKGROUND INFORMATION

Colorectal cancer kills 57,000 Americans each year, and is the second leading cause of cancer-related deaths in this country. According to the report published by American Cancer Society (ACS), an estimated 146,000 new colorectal cancer cases will be diagnosed yearly in the United States. The ACS estimates that by detecting and treating early-stage colorectal cancer can reduce the mortality rate by as much as 90%.

The underlying idea behind screening is that unlike many other types of cancer, colon cancer is easily curable if found early and also can be prevented by removing precancerous precursors (polyps). Both polyps and early-stage cancers are usually asymptomatic. Compared with these lesions, cancers that have grown large enough to cause symptoms have a much worse prognosis. This contrast highlights the need for screening in asymptomatic persons.

Fecal Occult Blood Test (FOBT) is the most commonly used method for initial screening of colorectal cancer. However, the conventional chemical test methods such as Guaiac test are not specific in detecting human occult blood. In order to get more accurate test results, it requires that certain foods, drugs, vitamins and many other substances be avoided 3-7 days before testing. In spite of this, pseudo-positive result remains as high as 30%.

In addition, a major drawback to Guaiac based fecal occult blood testing as a screening technique is poor compliance. Only about 38 percent of patients in the large trials completed all planned tests. The complexity includes patient preparation, inconvenience, facilities and equipment needed, and patient discomfort.

Hemosure®, an one-step, easy to use product developed by Hemosure, Inc. based on its years of clinical study, is the latest technological breakthrough in Immunological Fecal Occult Blood Testing (IFOBT), and it is both FDA approved and CLIA waived. Hemosure® employs a unique combination of monoclonal and polyclonal antibodies to detect only human blood in stool. As a result, abstinence of food and drug before taking this test is no longer necessary. These advantages can significantly enhance patient compliances.

In addition to the inherent specificity and sensitivity, Hemosure® test can be performed by health care providers in hospitals, labs and private practices. No need to send fecal samples to the laboratory. Doctors can easily, quickly and accurately read the test results within five to ten minutes. This new technology has greatly improved specificity, sensitivity, accuracy and cost-effectiveness of the fecal occult blood tests. Hemosure® has unquestionably set a new standard on how future fecal occult blood testing is carried out.

PRODUCT OVERVIEW:

Hemosure® is a trade name recognized worldwide in fecal immunochemical test (FIT). We make our FIT test fit your needs by making all the components available in a smart economical ordering kits as well as having all items available for sale separately. Regardless of how many tests you do per month there is packaging that will work best for you and your office or laboratory!

Hemosure One-Step Fecal Immunochemical Test

Is a qualitative, sandwich dye conjugate immunoassay and employs a unique combination of monoclonal and polyclonal antibodies to selectively identify in human feces, as an aid in diagnosis of fecal occult blood, with a high degree of sensitivity. In less than five minutes, elevated levels of human hemoglobin as low as 0.05ugHb/ml can be detected and positive results for high levels of hemoglobin can be seen in the test as early as one or two minutes.