Venaxis, Inc. (NASDAQ: APPY) is an in vitro diagnostic company focused on the development and commercialization of its leading product candidate, the APPY1™ Test. This novel blood-based diagnostic test is designed to aid in the evaluation of patients at low risk for acute appendicitis, allowing physicians to more effectively manage the large number of children and adolescents who enter hospital emergency departments with abdominal pain. Currently, determining if a patient requires emergency surgery for appendicitis normally requires diagnostic CT imaging, which is both expensive and time-intensive. In cases where imaging capacity is limited, patients are often admitted to the hospital in order to avoid the risk of appendicitis rupture at home, which adds significant cost for both patients and hospitals.
When fully commercialized, the APPY1 Test will provide physicians with a more cost-effective approach to diagnosing appendicitis. According to the Centers for Disease Control and Prevention, physicians ordered an estimated 7.5 million blood tests for abdominal pain in 2010, and approximately one million were performed on patients less than 21 years old. Statistically, these young patients have the highest risk of long-term health effects resulting from CT imaging. For this reason, Venaxis is initially developing the APPY1 Test for pediatric, adolescent and young adult patients.
In January, the FDA determined that the Appy1 Test did not meet the criteria for substantial equivalence based upon data and information submitted by Venaxis. As of the company’s latest business update in June, FDA clearance process and status for the APPY1 Test was still under evaluation. However, Venaxis is continuing to advance toward the commercialization of its innovative product through a limited launch in select European countries scheduled to begin in the coming months.
“The FDA decision is very disappointing,” Steve Lundy, president and chief executive officer of Venaxis, stated in a January news release. “We believe that the strong clinical trial results we achieved and the additional clinical utility information we provided to the FDA in response to its requests for additional information were compelling, and we intend to continue to work with the FDA to advance the progress of a blood-based diagnostic test to assist in the evaluation of appendicitis.”
Despite beginning the year with a disappointing FDA ruling, Venaxis has made significant strides toward improved financial results through the continued development of the APPY1 Test. For prospective shareholders, Venaxis’s unwavering commitment to the development of innovative alternatives to current appendicitis diagnostic techniques could provide a platform upon which to realize sustainable returns in the years to come.
For more information, visit www.venaxis.com
