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DiaDexus, Inc. (DDXS) Is “One To Watch”

diaDexus has developed the PLAC® Test ELISA Kit, the only FDA-cleared blood test for helping to predict both coronary heart disease and atherosclerosis-related ischemic stroke (respectively the number one and number three causes of death in the U.S. alone). Constantly striving to innovate along similar lines in the larger cardiovascular diagnostics space, DDXS has amassed quite the portfolio of technologies and continues to break new ground in unmet or underserved areas of the market.

The PLAC Test offers a powerful benchmarking framework for analyzing Lp-PLA2 levels (LDL or low density lipoprotein-associated phospholipase A2, a vascular-specific inflammatory enzyme which acts as a hallmark for the targeted conditions), a vector well established (with over 65 papers in publication that validate the function) for rupture-prone plaques (thrombosis) that inevitably lead to the vast majority of cardiac events.

It's a heart attack susceptibility test basically (immunoassay that quantifies enzyme level), and it's exactly the kind of product the company has become known for in the industry. In fact, with big players like GlaxoSmithKline throwing their hat in the ring behind this exceptionally useful cardiovascular risk marker, it is clear that Lp-PLA2 sensor products are a stable market with a big future.

It is clear from extant research that in as much as half of all cases of cardiovascular events, the nominal lipid levels mask a severe, life-threatening problem. But the PLAC Test leapfrogs the existing, inefficient, and obviously limited risk evaluation methods, using a powerful Lp-PLA2 metric that offers real hope to patients who are at risk. The PLAC Test can often red flag a case where more aggressive therapy targeting lower LDL-C categories, like statin use, could be implemented with life-saving results.

The market looks solid as well, with over 120M people in the U.S. currently covered via a CMS/NLA (Category I CPT Code via Centers for Medicare and Medicaid Services National Limitation Amount) reimbursement of $47.77 (2011 CMS Clinical Laboratory Fee Schedule) and the rest able to pay out of pocket for this simple blood test that is available nationally via clinical referral, hospitals, and cardiovascular labs. Think for a moment that atherosclerotic cardiovascular disease is also the top killer in Europe (product is also CE-marked) and then extrapolate these baseline metrics to the global market, you will immediately see the potential and the size of the unmet demand. Indeed, many people are caught up in a woefully ineffective LDL testing loop and are likely not even aware of the problem this ineffective test framework represents, nor the potentially life-saving capabilities of the PLAC Test.

The company has done a great job disseminating information though and since the July 2010 completion of the reverse merger, DDXS has continued to post excellent financials, with Q1 2012 revenues up 49% year-over-year to $4.9M, following up last year's FY11 data that showed revenues increase 39% from 2010 to $16.4M.

The recent report that Lp-PLA2 was included in the American Association of Clinical Endocrinologists (AACE) guidelines for clinical practice (published in March/April 2012 issue of Endocrine Practice) was yet another milestone for the company's PLAC Test product and offers shareholders every reason to smile with confidence. The natural receptivity and abundant documentation of the method of effect, combined with a national presence and ready availability has certainly made DDXS successful and the company intends to capitalize on this success by continuing to improve the PLAC Test, in parallel to new product R&D.

CEO of DDXS, Brian E. Ward, Ph.D., points to strands of the pertinent analysis of Lp-PLA2 measurement efficacy, like the AACE guideline inclusion, as a glowing endorsement of the PLAC Test ELISA Kit.

Lp-PLA2 was also recently looked at in two major studies (LIPID and JUPITER - reported Mar 19) that showed strong correlation between Lp-PLA2 level reduction and coronary heart disease that far exceeded the results of reducing LDL cholesterol (using statin therapy). These studies are a bit paradigm-shattering really, showing a serious link between Lp-PLA2 and incident rate, something that has not been looked at in previous studies. The JUPITER data shows Lp-PLA2 to be, according to Mr. Ward, clearly "predictive of cardiovascular events in apparently healthy men and women."

Needles to say, this San Francisco-based cardiovascular diagnostics powerhouse is a company to keep a close eye, the management has a clear strategy for identifying unmet demand and commercializing/placing IP in the market.

For more information on diaDexus, Inc., please visit the company's website at: diaDexus.com

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