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
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