Blood test to detect appendicitis AppyScore is coming: AspenBio Pharma

AppyScore will the first-ever blood test to diagnose appendicitis, if approved

AppyScore, a blood test to diagnose appendicitis in humans by AspenBio Pharma, Inc. is currently in clinical studies.

AspenBio Pharma is in the process of the Premarket Notification 510(k) submission of its ELISA format AppyScore test.

AppyScore is the first blood-based test designed to aid in the evaluation of patients suspected of having acute appendicitis, AspenBio Pharma said in a press release.

Preliminary results indicated that AppyScore ELISA triage screen test is highly effective in identifying patients with acute appendicitis. This marker demonstrates a strong correlation with the severity of appendicitis.

AppyScore 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.

AppyScore appendicitis blood test scoring system is designed to numerically measure the blood marker level, which guides the physician in determining not only the presence but also the potential stage or severity of appendicitis being experienced by the patient.

Determining the stage or severity of appendicitis helps the physician assess the level of possible danger and the potential for the appendix to perforate, potentially causing life-threatening complications.

AspenBio Pharma believes that AppyScore 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.

AppyScore test will cost-effectively and accurately assist emergency room personnel and primary care physicians to triage patients complaining of abdominal pain.

AppyScore 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 will also 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.

AppyScore supplemental clinical trial is being conducted with over 400 patients enrolled to-date from the emergency departments of more than a dozen well-known hospitals across the United States.

What is appendicitis?

Appendicitis is a common acute surgical problem primarily affecting children and young adults under 30 years of age. Appendicitis  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 alone 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.

Currently, there is 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.

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.

AspenBio Pharma is an emerging bio-science company dedicated to the discovery, development and commercialization of novel products that address unmet diagnostic and therapeutic needs in both human and animal health.