The AppyScore™ Solution

AppyScore™ is a novel, blood-based test designed to assist emergency physicians in the difficult challenge of evaluating patients suspected of having or not having acute appendicitis. A recent pilot study of 500+ patients demonstrated that AppyScore would have been an effective blood based test to aid in managing appendicitis in children and adolescents presenting with abdominal pain at hospital emergency departments, thus potentially obviating the need for CT scans in the low risk population. The test value will be confirmed in a pivotal clinical trial, the results of which will be submitted to the Food and Drug Administration for product marketing clearance. We believe that the availability of a test capable of assisting emergency physicians in improving diagnostic accuracy, assessing risk which could potentially reduce CT scans, and potentially reducing radiation exposure risk for patients, reducing health care costs, and increasing throughput in the emergency department. The AppyScore™ test is designed to help emergency physicians identify those patients who are at low risk for appendicitis, allowing clinicians to take a more conservative approach to patient management. The current focus of our efforts is the use of AppyScore™ in children and adolescents suspicious of the disease as this population is at the highest risk of the long term health effects associated with CT imaging.

Product Features

  • High sensitivity and high negative predictive value.
  • AppyScore™ fits in hospital lab workflow and ordinary turnaround time for hospital emergency department lab results.
  • AppyScore™ is a multi-marker blood test panel consisting of the company's patented MRP 8/14 biomarker and C - reactive protein ("CRP"), along with White Blood Cell Count ("WBC").
  • The scoring results of the individual components will be analyzed using the company's proprietary algorithm software embedded in the AppyScore cassette reader to provide a timely AppyScore™ result to the clinician.

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Abdominal pain is a high-volume, potentially high-risk complaint and represents the single largest reason for emergency department visits. For patients presenting with abdominal pain, accurately diagnosing appendicitis is among the primary concerns for emergency physicians because if left untreated, the inflamed appendix can perforate or burst, greatly increasing the patient's risk for complications, possibly death and certainly negatively impacting recovery time. Even with the most advanced diagnostic technologies available including CT, patients suspicious for appendicitis can be misdiagnosed. This potentially results in a patient either being sent to surgery only to find that the appendix was normal after being removed or being sent home to later find that the patient had appendicitis which may have burst due to the delay in treatment. Among children between 6 and 17 years of age, appendicitis is the second most common cause of malpractice litigation against emergency physicians. The diagnosis of appendicitis can be challenging even in the most experienced of clinical hands.

Given the challenges of diagnosing appendicitis, it is not surprising that the use of computed tomography (CT) has become widespread.

  • CT scanning presents several well-documented downsides, including exposure to ionizing radiation, risks associated with the use of intravenous contrast dye, overall time to schedule and conduct a CT, increased resource use, increased length of evaluation, and cost (ACEP Clinical Policy).
  • The risks relative to radiation exposure depend on both sex and age at exposure, with children and pregnant or potentially pregnant females at highest risk (Brenner). Therefore, the ability to identify patients with low probability of appendicitis and reduce the use of CT in these patients would be of great value to clinicians and patients alike.

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