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MDxHealth Provides Third Quarter 2012 Business Update

IRVINE, CA and LIEGE, BELGIUM -- (Marketwire) -- 11/15/12 -- MDxHealth SA (EURONEXT BRUSSELS: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today published a business update for the third quarter ending September 30, 2012.

Highlights
In Q3 2012, MDxHealth made significant progress across all facets of its business. On July 4, 2012, the company raised EUR 10 million in new equity funding via a private placement. As of September 30, 2012, the company had EUR 13.9 million of cash on hand. Commercial product and service revenues in Q3 increased 142% compared to the same period last year, with total revenues of EUR 2.9 million in the first nine months of 2012, an increase of 90% versus the same period in 2011.

The commercial roll-out of ConfirmMDx™ for Prostate Cancer, launched at the end of May of this year, is advancing according to expectations. In July, MDxHealth signed a collaboration agreement with Merck KGaA for the development and worldwide commercialization of MDxHealth's MGMT diagnostic test, PredictMDx™ for Glioblastoma.

In August, the company received CAP (College of American Pathologists) accreditation, as well as licenses from Florida and Pennsylvania, for its CLIA reference laboratory in Irvine, CA.

"We are very pleased with the acceptance of the ConfirmMDx for Prostate Cancer test among the US urology community as evidenced by our sales growth. The rising market awareness and adoption of the ConfirmMDx test reflect increasing momentum of our sales and marketing efforts," said Dr. Jan Groen CEO of MDxHealth. "Based on the favorable market reception, it is clear that our epigenetic test provides urologists with valuable information to help address false-negative biopsy concerns with their patients. This early success gives me confidence that ConfirmMDx will also deliver value for the company and its shareholders."

Key non-audited financials as of September 30, 2012

Amounts as at and for the three months ended

----------------------------------------------------------------------
Euro thousands                   Sept 30, 2012        Sept 30, 2011
----------------------------------------------------------------------
Commercial Revenues                   644                  267
----------------------------------------------------------------------
Total Revenues                        925                  378
----------------------------------------------------------------------
EBITDA (Loss)                       (2,244)              (1,760)
----------------------------------------------------------------------
EBIT Operating Income (Loss)        (2,330)              (1,862)
----------------------------------------------------------------------
Net Profit (Loss)                   (2,321)              (1,879)
----------------------------------------------------------------------
Cash and cash equivalents           13,899               12,916
----------------------------------------------------------------------

Amounts as at and for the nine months ended

----------------------------------------------------------------------
Euro thousands                  Sept. 30, 2012        Sept 30, 2011
----------------------------------------------------------------------
Commercial Revenues                  2,100                1,086
----------------------------------------------------------------------
Total Revenues                       2,939                1,785
----------------------------------------------------------------------
EBITDA Income (Loss)                (6,293)              (5,444)
----------------------------------------------------------------------
EBIT Operating Income (Loss)        (6,590)              (5,713)
----------------------------------------------------------------------
Net Profit (Loss)                   (6,580)              (5,692)
----------------------------------------------------------------------
Cash and cash equivalents           13,899               12,916
----------------------------------------------------------------------

Commercial revenues up 90% for the first 9 months

Revenues
The total revenues for the first nine months of the year amounted to EUR 2.9 million, of which EUR 2.1 million represent commercial revenues, up 90% compared to the same period last year.

Operating Expenses
The company's operating expenses were EUR 9.2 million in the first nine months of 2012, versus EUR 7.3 million in the same period in 2011, as the company continued to invest in the development of its product pipeline and sales and marketing activities in the US.

Cash Position
As of September 30, 2012, MDxHealth had EUR 13.9 million in cash, compared to EUR 12.9 million on September 30, 2011, EUR 1.0 million higher than the same period last year.

Outlook for fourth quarter and FY 2012
In Q4 2012, the company expects to report an increase in commercial product and service revenues compared to previous quarters, primarily due to continuing growth in sales of our ConfirmMDx for Prostate Cancer test in the US and commercial service revenues from our ongoing PharmacoMDx collaborations with Merck Serono, GSK Biologicals and other partners. The health economic study for the ConfirmMDx for Prostate Cancer test, providing healthcare providers with important cost comparison data, is scheduled to be submitted for publication. Total operating costs in Q4 are expected to increase due to higher sales and marketing and other operating activities.

About MDxHealth
MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. The company's first commercial product, the ConfirmMDx™ for Prostate Cancer test, has been shown to help distinguish patients who have a true-negative biopsy from those who may have occult cancer. MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. The company has a proprietary platform and a strong epigenetic product pipeline focused on the development of products for brain and lung cancers. The company is based in Irvine, California with a European headquarters in Liege, Belgium. For more information visit MDxHealth website at www.mdxhealth.com.

This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation.

Q3 2012 ENG: http://hugin.info/137314/R/1657741/536263.pdf

For more information:
Dr. Jan Groen
CEO
MDxHealth
US: +1 949 812 6979
BE: +32 4 364 20 70
[email protected]

Mike Sinclair
Halsin Partners
UK: +44 20 7318 2955
Cell: +44 7968 022075
[email protected]

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