Venaxis Reports on Recent FDA Submission Activities

             Venaxis Reports on Recent FDA Submission Activities

PR Newswire

CASTLE ROCK, Colo., July 16, 2014

CASTLE ROCK, Colo., July 16, 2014 /PRNewswire/--Venaxis, Inc. (Nasdaq: APPY),
an in vitro diagnostic company focused on obtaining FDA clearance for and
commercializing its CE Marked APPY1™ Test, a rapid, multi-analyte assay for
aiding in identifying children, adolescent and young adult patients that are
at low risk for appendicitis, updated on recent activities concerning its U.
S. Food and Drug Administration (FDA) submission for the APPY1 Test that was
filed in March 2014. The FDA has reviewed the submission, and provided Venaxis
with questions and information requests on the submission. 

Venaxis is compiling responses to the FDA's questions and their requests for
additional data and information, as well as seeking clarification from the FDA
on certain of its requests. Under the FDA's Submission Issue Meeting
procedures, we expect a meeting in the upcoming weeks to discuss the items on
which we seek clarification.

Steve Lundy, President and CEO of Venaxis, stated, "We are encouraged by the
FDA's responsiveness to our filing and look forward to working collaboratively
with the FDA to complete the review process."

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, multi-analyte 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, a limited commercial
launch for the APPY1 Test is ongoing in select European countries. For more
information, visit

Forward-Looking Statements
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 obtain FDA clearance or approval, maintain
CE Marking, cost effectively manufacture and generate revenues from the
APPY1Test 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 its
Form 10-K for the year ended December 31, 2013, filed with the SEC on March
28, 2014.

Venaxis and APPY1 are trademarks of Venaxis, Inc.

Contact – Jed Mahan,; (303) 794-2000 Ext. 255

SOURCE Venaxis, Inc.

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