Appendicitis Test
Human Appendicitis Diagnostic Test
Appendicitis is a common acute surgical problem affecting patients of a wide age range. It is estimated that there are approximately 700,000 cases annually in the United States and approximately 6,000,000 patients enter US emergency rooms annually complaining of abdominal pain. An accurate diagnosis at a sufficiently early stage is a significant factor in achieving a successful patient outcome. An accurate and early diagnosis, however, is expensive and difficult because there is considerable overlap of genuine appendicitis with other clinical conditions. Furthermore, to date there appears to be no individual sign, symptom, test, or procedure capable of providing a reliable indication of appendicitis. Misdiagnosis of appendicitis can lead not only to unnecessary surgery but also to delay of proper therapy for the actual underlying condition. A dilemma for surgeons is minimizing the negative appendectomy surgery rate without increasing the incidence of perforation among patients referred for suspected appendicitis.
Techniques currently used by emergency room doctors to diagnose millions of patients complaining of stomach and abdominal pain are expensive, time consuming and can have error rates estimated at between 15% and 40%. Currently no known effective appendicitis diagnostic test is available on the market in the United States or internationally. The only other diagnostic product marketed specifically to detect appendicitis was a radiological drug which was designed to be injected into the body and then have the patient X-rayed, this drug was recently pulled from the US market by the FDA.
Based upon preliminary work we have been performing on the test (patent pending), it shows early promise as an excellent indicator of appendicitis. The project is in an advanced research and development phase as blood and tissue samples are now being harvested and banked. Testing is ongoing to characterize the markers that could be used to assist in the rule out of appendicitis or determine the diagnosis of the condition. Significant additional development and testing over the upcoming months will be required to determine the exact commercial product form that would be brought to market. Prior to any product introduction into the marketplace — assuming successful commercial development can be achieved — significant clinical trials and FDA approval would be required, the successful completion of which cannot be assured. It should be noted that the FDA approval process for a diagnostic test such as this is generally much shorter than for a drug and potentially may be achievable in as little as 12 months.
Our goal is to create a blood-based test designed to quickly and accurately assist in diagnosing or ruling out appendicitis in humans. We have been working for some time in a productive collaboration with Dr. John Bealer, an experienced pediatric surgeon based in Denver, Colorado, to develop and refine this technology by discovering diagnostic markers through genomic and proteomic screening approaches. Dr. Bealer has been the catalyst in the progress we have made in the development of this technology. Our expertise in diagnostic development helped advance this test to the point where we are excited about the possibility of providing a blood test that cost-effectively and accurately assists emergency room personnel quickly diagnose or rule out appendicitis in patients complaining of abdominal pain.
Currently this test is expected to be sold into the human emergency room diagnostic market and be used primarily by emergency room physicians and lab personnel worldwide. If successfully developed, we expect our test to be the only blood based screen or rule out test specifically for appendicitis in the worldwide market. We believe that this test would be marketed under an agreement with a large pharmaceutical company, following successful completion and FDA approval. The potential worldwide market for this product is vast. In the United States alone it is estimated that approximately 6,000,000 patients enter US emergency rooms annually complaining of abdominal pain. As a screening or rule out test we anticipate our appendicitis test, if successfully completed could be used to test a large portion of these patients to aid the physician in his or her efforts to more rapidly determine a diagnosis.
