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MDxHealth SA

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Market Data: Yahoo Finance, Bloomberg

Report Link: Updated Research Report (Dated 05/23/2017)

Symbol: MXDHF
Analyst: Howard Halpern
Taglich Rating: Speculative Buy
Price Target: $7.90
Time Horizon: 12 Months
Rating Established: May 5, 2016
Price When Established: $4.03
Most Recent Report: May 23, 2017
Price When Issued: $5.45

What's New

MDxHealth Appoints Executive Vice President of Sales for North America

On August 7, 2017, MDxHealth announced the appointment of Paul Marr as Executive Vice President of Sales for North America. He will lead a newly expanded US sales force of 50 representatives.

Mr. Marr had more than 20 years of sales leadership experience in clinical diagnostics. He most recently served as VP of Sales, North America at Beckman Coulter, a Danaher Company. He previously served in senior leadership positions at Hologic, Gen-Probe, Leica Biosystems, Bayer Diagnostics and Siemens Healthcare.

The North American sales force will be focused on market opportunity for the company’s portfolio of molecular diagnostic tests for urology, including ConfirmMDx, its new SelectMDx liquid biopsy test, and the recently launched liquid biopsy bladder cancer test, AssureMDx.

MDxHealth Enters Agreement with First German Medical Laboratory for SelectMDx

On July 31, 2017, MDxHealth announced MVZ Dr. Stein & Kollegen medical laboratory has signed an agreement to become the first German laboratory to offer its SelectMDx for Prostate Cancer test.

MVZ Dr. Stein & Kollegen medical laboratory in Mönchengladbach Germany will perform SelectMDx service testing through their laboratory network. MVZ will purchase SelectMDx CE-marked IVD kits from MDxHealth.

The company believes that MVZ’s broad hospital network and commercial capabilities will significantly contribute to the successful market penetration of SelectMDx.

MDxHealth Launches SelectMDx in vitro diagnostic PCR kit in Europe

In June, 2017, MDxHealth launched in Europe its SelectMDx for Prostate Cancer in vitro diagnostic PCR kit with CE-marked components and CE-marked UrNCollect device.

The in vitro diagnostic PCR kit will enable diagnostic laboratories with manual and automated RNA extraction and PCR platforms to perform the SelectMDx liquid biopsy test in their own facility.

The company expects some of its current customers will start using the kits in order to perform the SelectMDx for Prostate Cancer test in their own labs.

MDxHealth Enters Distribution Agreement with IPS Gexomix for SelectMDx

On July 10, 2017, MDxHealth announced the singing of a commercial agreement with IPS Genomix for the distribution of its SelectMDx for Prostate Cancer test in the Middle East.

IPS Genomix is ideally positioned to reach the estimated 1 million men across Lebanon, Egypt, United Arab Emirates, Saudi Arabia, Oman, Bahrain, Qatar, and Jordan with an elevated PSA, who would be potential candidates for SelectMDx.

The agreement calls for IPS Genomix to handle distribution and reimbursement within the Middle East, while MDxHealth will perform the SelectMDx testing service in its ISO certified clinical diagnostic laboratory in Nijmegen, The Netherlands. IPS Genomix will reimburse MDxHealth for all testing services performed.

MDxHealth Launches AssureMDx for Bladder Cancer

On July 6, 2017, MDxHealth announced the commercial launch of its AssureMDx™ for Bladder Cancer test in the US as a laboratory developed test. Testing will be conducted at the company's CAP and CLIA accredited laboratory facilities in Irvine, California.

AssureMDx is a non-invasive, urine-based test, combining methylation and mutation biomarkers, to assess the risk of bladder cancer for patients diagnosed with hematuria. AssureMDx has been validated to improve upon the standard of care, helping rule out the risk of bladder cancer with a negative predictive value of 99%.

In the US each year it is estimated that nearly 11 million patients are referred to a urologist for clinical evaluation due to blood in urine. Blood in the urine is the most common symptom of bladder cancer, however only 3% to 28% of those patients are diagnosed with bladder cancer.

Company Description

MDxHealth, headquartered in Herstal, Belgium, was established in 2003. The company maintains a US headquarters in Irvine, CA, and operates a CLIA (Clinical Laboratory Improvement Act) diagnostic laboratory in Irvine, California, and a laboratory in Nijmegen, the Netherlands.

The company has developed noninvasive diagnostics based on epigenetics, which uses selected biomarkers to detect the presence of cancer and gauge the extent of its progress by analyzing a patients’ tissue, blood or urine samples. Biomarkers are measurable structures or processes in the body that indicate the presence of a disease and, potentially, the effects of treatments for that disease.

MDx’s lead product, ConfirmMDx, was launched in 2012. ConfirmMDx, analyzes a biopsy tissue sample from suspected prostate cancer cases who have tested negative. As initial biopsies (as well as follow-up ones) can be inconclusive, repeat biopsies are frequently performed to verify or rule out a diagnosis of prostate cancer. Confirm MDx can confirm a true negative biopsy, sparing the patient the ordeal and risks of unnecessary repeat biopsies. It can also identify cases of undetected cancer.

SelectMDx was launched in Europe in 2015 and in the US in March 2016. Select MDx, an initial diagnostic tool, analyzes a patient’s urine and identifies patients at low risk for prostate cancer, as well as patients at high risk for undetected aggressive prostate cancer that should be treated with greater urgency.

MDx is also developing AssureMDx, a bladder cancer test, and is exploring diagnostics for kidney cancer. The company has developed markers for non-urologic – colon, brain and cervical – cancers that have been licensed to other diagnostic companies, adding royalties and milestone payments to its potential revenue stream.

At current incidence rates, the number of US men diagnosed with prostate cancer could rise to 255,000 by 2050, up from an estimated 181,000 in 2016. Almost three million men in the US who have been diagnosed with prostate cancer at some point in their lives are alive today. Roughly 26,000 US patients will succumb to the disease in 2016 We believe that the statistics for Western Europe are comparable.

As non-invasive and inexpensive diagnostics, ConfirmMDx and SelectMDx could significantly reduce the cost of prostate cancer diagnosis by enabling patients to avoid biopsies − they cost the US healthcare system around $4 billion annually − and improve outcomes by identifying cases of potentially lethal fast growing disease more quickly.

Company Reports

Updated Research Report (Dated 05/23/2017)

Updated Research Report (Dated 08/24/2016)

Initial Research Report (Dated 05/05/2016)


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