AppyScore Human Appendicitis Triage Blood Test
Appendicitis is a common acute surgical problem primarily affecting children and young adults under 30 years of age. It typically is an acute event that occurs between 24 and 36 hours from the initiation of symptoms to the point where if it is not operated on and removed it may perforate or burst causing a potentially life threatening event for the patient. It is estimated that approximately 6,000,000 patients enter U.S. emergency rooms with abdominal pain and that after diagnosis this results in approximately 320,000 appendicitis surgeries. An accurate diagnosis of appendicitis is a difficult challenge for emergency room doctors and the ability to do so effectively is a significant factor in achieving a successful patient outcome. An accurate and effective diagnosis, however, can be time consuming, expensive and difficult because there is considerable overlap of appendicitis with other clinical conditions. Furthermore, to date there appears to be no individual sign, symptom, test, or procedure capable of providing a reliable diagnosis of appendicitis. Misdiagnosis of appendicitis can lead not only to unnecessary surgery but also to delay of proper therapy for the actual underlying condition. Published data indicates that in the United States, an estimated 15-20% of appendectomies remove a normal appendix due primarily to incorrect diagnosis prior to surgery. In addition, approximately 58,000 patients suffer a perforated (or burst) appendix because they are not diagnosed in time. 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 high error rates. After performing basic tests and a physical health examination, a CT scan is the most commonly used emergency room diagnostic method used in the U.S. to rule out appendicitis for patients with abdominal pain. Currently the total estimated cost of an abdominal or pelvic CT scan plus associated fees can range from several hundreds of dollars to well over several thousands of dollars per procedure resulting in a total estimated expense of over $1.0 billion annually in the U.S. on CT to diagnose appendicitis. The scans can take more than four hours to complete (including typical processing time) and expose many patients to extremely high levels of ionizing radiation. While CT scans are still the current medical standard for diagnosing appendicitis, CT diagnostic error rates are estimated to exceed 15% and a high percentage of CT scans are simply inconclusive. The present approach contributes to a significantly large number of unnecessary (negative) appendicitis surgeries and false-negatives due to diagnostic errors.
In addition to health risks, hospital charges for unnecessary (negative) appendectomies are estimated to cost greater than $400 million annually in the U.S. alone (Flum et al., Arch Surg. 2002;137:799-804). Additionally up to 25% of patients are not diagnosed correctly in time and suffer a potentially life-threatening perforation of the appendix requiring immediate and more complex emergency surgery. Due to a very high risk of serious internal infection, perforated appendix cases require a more lengthy hospital stay, longer recovery or treatment period, substantially increased cost and tremendous discomfort for the patient. Appendicitis is one of the leading causes of litigation related claims of medical malpractice due to many factors including high diagnostic error rates, negative appendectomies, and increased cost and complications in cases where the appendix perforates.
Appendicitis most frequently occurs in patients aged 10 to 30, but can affect all ages. The appendicitis condition usually involves abdominal pain. Appendicitis is especially difficult to diagnose in children and young adults using a CT scan because many patients in this age group have low body fat resulting in very poor tissue differentiation or contrast on the CT scan. Our new blood-based appendicitis triage or screening test also has the potential to enhance overall safety by reducing the amount of radiation exposure from unnecessary CT scans.
The Company continues to make progress in the development and testing of its first-generation blood-based human diagnostic tests designed to rapidly aid in the diagnosis of appendicitis in patients complaining of abdominal pain. Specifically, we have created and optimized a specialized test to detect a marker in the blood associated with appendicitis and have tested this assay in several clinical research trials involving hundreds of human patients.
Preliminary results indicate that our first-generation ELISA triage screen test is highly effective in identifying patients with acute appendicitis. This marker demonstrates a strong correlation with the severity of appendicitis. As a result of these positive developments, the Company is advancing its appendicitis triage blood screen test AppyScore, which is based on a blood test result scoring system designed to be used as an initial appendicitis triage or screening test for patients entering an emergency department or urgent care facility complaining of abdominal pain. We anticipate that our new appendicitis triage screening test will be incorporated in routine blood testing as a patient’s blood sample is taken in the ordinary course of an initial assessment of any patient entering the emergency department.
Our creativity in discovery efforts and expertise in diagnostic development helped advance this test to the point where we are optimistic about the possibility of bringing AppyScore to market. We believe this test will cost-effectively and accurately assist emergency room personnel and primary care physicians to triage patients complaining of abdominal pain. Our test is designed to quickly divide abdominal patients into two patient groups, those at high risk of being appendicitis cases and those which are not. AppyScore is designed to provide the emergency department physicians with more accurate individual patient information on suspected appendicitis cases and in a time frame much faster than previous technology would allow.
Our first-generation AppyScore test is expected to be sold into the emergency room diagnostic market. If successfully developed and cleared by the FDA, we expect our patented test to be the only blood based triage screen specifically for appendicitis in the worldwide market. We believe there is a significant worldwide market opportunity for this product.
