bio1021 - a novel point-of-care diagnostic test for appendicitis

Appendicitis is the most common medical emergency that results in an operation, yet diagnosis is still mainly reliant on physical examination and a series of signs and symptoms that are non-specific and common to a variety of possible conditions. Currently, there are no rapid diagnostic tests specifically for appendicitis.

biOracle's new diagnostic test for appendicitis promises to change this situation dramatically, for the first time providing clinicians with a test that is accurate, specific and, equally importantly, quick and easy to administer at the point of care. 

Based on a novel marker that can easily be measure at the point of care, the new test will help clinicians to assess patients more quickly and more accurately, ensure that patients receive treatment as rapidly as possible, and reduce the number of unnecessary appendicectomies (appendectomies) that are carried out.

Some facts about appendicitis

About bio1021

Some facts about appendicitis

• every year, 10 million patients present to emergency rooms in the USA with abdominal pain which could be appendicitis
   
• around 8% of people will be affected by appendicitis at some stage in their life
   
• the prevalence of appendicitis is 16 per 10,000 in the USA, resulting in as many as 500,000 cases per year
   
• in patients suspected of having appendicitis and who have surgery to remove their appendix, in 20 - 30% of cases the appendix turns out to be normal
   
• 1 in 10 patients who have surgery to remove their appendix experience complications as a consequence of the surgery
   
• 15% of patients who have surgery for suspected appendicitis that turns out not to be appendicitis have complications
   
• death rates from appendicitis due to delays and complications such as peritonitis are in the range from 0.17 to 7.5%
   
• misdiagnosis rates for appendicits in children under the age of 2 and young females can be as high as 20% to 45% respectively
   
• perforated appendix occurs in between 4 - 4.5% of cases, with perforation rates being significantly higher in the over-35's and under-15's (where perforation rates can be as high as 36%)

About bio1021

bio1021 is a rapid, point of care diagnostic test that can be used as an aid to the diagnosis of appendicitis. The test is carried out on a urine sample from a patient with suspected appendicitis. The test can be used along with other clinical signs and symptoms of appendicitis to help clinicians reach more informed decisions when faced with an uncertain diagnostic picture.

Based on proprietary patented technology that recognises a unique marker present at elevated levels in the urine of patients with acute appendicitis, bio1021 has the potential to radically alter and improve diagnosis and treatment of suspected appendicitis, as well as being an effective screening tool in the management of abdominal pain.

Main advantages of bio1021

• simple - a colorimetric test that can be carried out easily at the point of care
• fast - results are available in minutes
• reliable - clinical evaluation shows that bio1021 is more specific to appendicits than any other individual diagnostic parameter
• cost effective - more economic than many other diagnostic tests commonly used for patients with suspected appendicitis
• convenient - rapid and accurate results when they are most needed