SOUTH SAN FRANCISCO, Calif.,
Jan. 9, 2012 /PRNewswire/ --
diaDexus, Inc. (OTC Bulletin Board: DDXS.OB), a diagnostics company
focused on patent-protected in vitro diagnostic products
addressing unmet needs in cardiovascular disease, today announced
preliminary Q4 2011 revenues of approximately $4.9 million, up 48% from the prior year's fourth
quarter. This result brings projected year-end 2011 revenue to
$16.4 million, up 39% over 2010's
full year revenues. These preliminary results are unaudited and
subject to adjustment prior to the Company filing its Annual Report
on Form 10-K on or before March 21,
2012.
The Company also announced a preliminary cash and investments
balance of approximately $17.2
million as of December 31,
2011. This preliminary balance is unaudited and subject to
adjustment prior to the Company filing its Form 10-K on or before
March 21, 2012.
diaDexus provided new guidance for 2012 total revenue at
$20 - 21 million, estimating
year-over-year growth of approximately 26% compared to 2011.
According to Brian E. Ward, Ph.D,
Chief Executive Officer, "2011's strong revenue growth reflects
significant assay purchases by cardiovascular specialty
laboratories. diaDexus' dominant role as the only supplier of
LP-PLA2 assays in this market, plus the fact that the PLAC
Test has become a cornerstone of comprehensive diagnostic lipid
profile analysis, are the primary contributors to this
growth. We also believe that guidelines published in 2010 and 2011
by the American Heart Association and the American Stroke
Association to support testing of LP-PLA2, coupled with emerging
clinical utility data, are increasing physician awareness of this
important cardiovascular risk assessment tool. Looking forward, we
believe this growth trend will continue to be fueled by penetration
of more generalized laboratories, our new activity assay which will
be launched in Europe, broader
reimbursement coverage, and additional positive clinical outcomes
data."
The company expects to report 2011 year-end financial results on
or around March 21, 2012.
About diaDexus, Inc.
diaDexus, Inc., based in South San
Francisco, California, is focused on the development and
commercialization of patent-protected in vitro diagnostic products
addressing unmet needs in cardiovascular disease. The company's
PLAC Test for Lp-PLA2 is the only blood test cleared by the FDA to
aid in predicting risk for both coronary heart disease (CHD) and
ischemic stroke associated with atherosclerosis, the #1 and #3
causes of death, respectively, in the
United States. For more information, please visit the
company's website at www.diaDexus.com
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such statements include, but are not limited to, statements about
the company's plans, objectives, expectations and intentions with
respect to future operations and products and other statements that
are not historical in nature, particularly those that use
terminology such as "will," "potential", "could," "can," "believe,"
"intends," "continue," "plans," "expects," "estimates" or
comparable terminology. Forward-looking statements are based on
current expectations and assumptions, and entail various known and
unknown risks and uncertainties that could cause actual results to
differ materially from those expressed in such forward-looking
statements. Important factors known to diaDexus that could cause
actual results to differ materially from those expressed in such
forward-looking statements include diaDexus' ability to maintain
regulatory clearance for and successfully commercialize its PLAC
test, including its ability to submit a new 510(k) application for,
and obtain FDA clearance of, its new automated Lp-PLA2 activity
assay; its ability to hire a chief financial officer and to
attract, retain and motivate other qualified personnel: its
relationship with key customers; diaDexus' reliance on sole source
third party manufacturers to manufacture and supply diaDexus' main
reagent and the PLAC Test; the effects of government regulations
and the company's ability to comply with such regulations;
diaDexus' ability to demonstrate that treatment of individuals
based on their Lp-PLA2 levels improves clinical outcomes in
prospective clinical studies; the rate of adoption of the PLAC Test
by doctors and laboratories; third party payors' acceptance of and
reimbursement for the PLAC Test; downward pressure on diaDexus'
product pricing, particularly from the company's largest customers;
the adequacy of the company's intellectual property rights;
diaDexus' limited revenue and cash resources; diaDexus' ability to
accurately forecast revenues prior to review and issuance of its
financial statements for the year ending December 31, 2011; and diaDexus' significant
corporate expenses, including real estate liabilities and expenses
associated with being a public company. Additional factors that
could cause diaDexus' results to differ materially from those
described in the forward-looking statements can be found in
diaDexus' most recent annual report on Form 10-K and subsequent
quarterly reports on Form 10-Q and other reports filed with the
Securities and Exchange Commission, and available at the SEC's web
site at www.sec.gov. The information set forth herein speaks only
as of the date hereof, and diaDexus disclaims any intention and
does not assume any obligation to update or revise any forward
looking statement, whether as a result of new information, future
events or otherwise.
SOURCE diaDexus, Inc.