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CASTLE ROCK, Colo.,
June 13, 2013 /PRNewswire/ --
Venaxis, Inc. (Nasdaq: APPY), an
in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked
APPY1 Test, a rapid, protein biomarker-based assay for identifying patients at low risk for appendicitis, today announced its support of key findings from a large retrospective study that was published earlier this week in the peer-reviewed medical journal
JAMA Pediatrics. The study concluded, among other things, that the risk of radiation-induced solid cancers was highest for patients undergoing CT scans of the abdomen/pelvis and that abdominal/pelvic scans saw the most dramatic increase in use over the study period, especially among older children. Possible appendicitis was cited as a leading cause of abdominal/pelvic CT usage.
Importantly, the authors of the study concluded that reducing unnecessary CT scans in favor of other imaging or non-imaging approaches (if proven through research to be as effective), combined with effective radiation dose-reduction strategies, could dramatically reduce the number of radiation-induced cancers.
Steve Lundy, President and CEO of Venaxis, stated, "The findings of this large observational study are aligned with our focus – developing a blood-based
APPY1 Test to aid physicians in identifying patients at low risk for acute appendicitis. We applaud the authors of the study for reporting these findings and for highlighting the urgent need for research to determine when the use of CT scans leads to improved health outcomes and when
other imaging and non-imaging diagnostic techniques could be as effective. The
APPY1 Test is designed to provide rapid, objective results and has demonstrated high negative predictive value for appendicitis in clinical studies. Venaxis' goal with the
APPY1 Test is to provide physicians with an additional tool that may allow for more conservative patient management, including reducing the number of CT scans."
JAMA Pediatrics study measured the rate of CT scan use (from 1996 to 2010) and the dose of ionizing radiation (for CT scans performed between 2001 and 2011) in children younger than 15 years of age, and estimated the lifetime attributable risks of certain cancers. The projected lifetime attributable risk of developing solid cancers was higher for patients who underwent CT scans of the abdomen/pelvis or spine than for patients who underwent other types of CT scans. The risk was highest for younger patients and for girls, with a radiation-induced solid cancer projected to result from every 300 to 390 abdomen/pelvis scans.
About Venaxis, Inc. Venaxis, Inc. is an
in vitro diagnostic company focused on the clinical development and commercialization of its CE Marked
APPY1 Test, the Company's rapid, protein biomarker-based assay for appendicitis. This unique appendicitis test has projected high sensitivity and negative predictive value and is being developed to aid in the identification of patients at low risk for acute appendicitis, allowing for more conservative patient management. The
APPY1 Test is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the highest risk for appendicitis and has the highest risk of long-term health effects associated with CT imaging. While FDA clearance is being sought, an initial launch for the
APPY1 Test is ongoing in select European countries. For more information, visit
This press release includes "forward-looking statements" of Venaxis, Inc. ("Venaxis") as defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact, included in this press release that address activities, events or developments that Venaxis believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors Venaxis believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Venaxis. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including our ability to successfully complete required product development and modifications in a timely and cost effective manner, complete clinical trial activities for the
APPY1 Test required for FDA submission, obtain FDA clearance or approval, maintain CE Marking, cost effectively manufacture and generate revenues from the
APPY1 Test at a profitable price point, execute agreements required to successfully advance the company's objectives, retain the management team to advance the products, overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property rights, and realize value of intangible assets. Furthermore, Venaxis does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this press release should be considered in conjunction with the risk factors contained in Venaxis' recent filings with the SEC, including the prospectus filed on
May 24, 2013.
For Investors and Media:Tiberend Strategic Advisors, Inc.Joshua Drumm, PhD
firstname.lastname@example.org; (212) 375-2664
Claire Sojdacsojda@tiberend.com; (212) 375-2686
SOURCE Venaxis, Inc.