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MDxHealth SA

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Market Data: Yahoo Finance, Bloomberg

Report Link: Research Note Released (Dated 05/16/2018)

Symbol: MXDHF
Analyst: Howard Halpern
Taglich Rating: Speculative Buy
Price Target: $5.00
Time Horizon: 12 Months
Rating Established: May 5, 2016
Price When Established: $4.03
Most Recent Report: May 16, 2018
Price When Issued: $4.40


What's New

MDxHealth Announces Licensing Agreement Facilitating Launch of InformMDx

On June 6, 2018, MDxHealth announced it reached a worldwide licensing agreement with Philips for prognostic prostate cancer biomarker (terms not disclosed). The licensing agreement gives the company rights to manufacture and market Philips` recently validated prognostic biomarker for prostate cancer, as a prognostic test (based on technology jointly developed by Philips Research and The University of Glasgow).

The agreement enables MDxHealth to prepare the launch of its InformMDx test for prostate cancer. Management believes this agreement moves the company closer to launching the InformMDx test, which would be its fourth commercial test. InformMDx should provide value by providing physicians with critical information required to make an informed therapeutic decisions for men recently diagnosed with prostate 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 05/16/2018)

Updated Research Report (Dated 03/05/2018)

Updated Research Note (Dated 01/11/2018)

Updated Research Note (Dated 11/07/2017)

Updated Research Report (Dated 09/12/2017)

Updated Research Report (Dated 05/23/2017)

Updated Research Report (Dated 08/24/2016)

Initial Research Report (Dated 05/05/2016)


Disclaimer

Please view our current disclosure and disclaimer on our most recent research report.