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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 SelectMDx Study Demonstrates Cost-effectiveness in US

On July 21, 2018, MDxHealth announced publication in The Journal of Urology of a study validating the cost-effectiveness of its SeclectMDx for Prostate Cancer test.

The study illustrated that by incorporating the company’s SelectMDx test it resulted in an average gain of 0.045 life years in full health gained at a cost-savings of $1,694 for each patient undergoing biopsy. Extrapolating these data to a conservative estimate of 311,879 patients per year undergoing biopsy resulted in 14,035 life years in full health gained with an annual cost saving of more than $500 million for each cohort.

Management stated that this study is another milestone that reinforces the company strategy to pursue the primary care market. If the primary care market is penetrated successfully, it could quadruple the SelectMDx market in the US and Europe to more than two million patients annually.

MDxHealth Announces Medicare Establishes Final LCD for use of ConfirmMDx

On July 23, 2018, MDxHealth announced Palmetto GBA, a Medicare Administrative Contractor that assesses molecular diagnostic technologies, has issued a positive final Local Coverage Determination (LCD) to expand Medicare coverage of the ConfirmMDx for Prostate Cancer test.

On September 3, 2018, the final LCD, which expands Medicare coverage to all providers, becomes effective. The company anticipates this streamlined LCD should enable it to broaden the impact of ConfirmMDx, facilitating access for all men covered by Medicare.

MDxHealth Announces Positive Data on SelectMDx Test

On June 27, 2018, MDxHealth announced the publication of positive data demonstrating the value of the SelectMDx liquid biopsy test for Prostate Cancer in guiding patient management for men being considered for multiparametric MRI.

Management believes this study shows the clinical utility of SelectMDx for biopsy decision-making in real-world clinical practice.

The author of the study observed that the use of genomic classifiers such as SelectMDx is set to revolutionize the way patients are managed with prostate cancer, predicting with extreme accuracy the likely biopsy findings and allowing for tailored advice.

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)


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