MDxHealth Launches CE-Marked SelectMDx IVD PCR Kit and UrNCollect Device
NEWS RELEASE / REGULATED INFORMATION / INSIDE INFORMATION / FOR EX-US ONLY
IRVINE, CA, and HERSTAL, BELGIUM – 07:00 CEST, June 08, 2017 – MDxHealth SA (Euronext: MDXH.BR) today announced the launch in Europe and other markets* of the SelectMDx® for Prostate Cancer in vitro diagnostic (IVD) PCR kit with CE-marked components and CE-marked UrNCollect(TM) device.
The IVD 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 CE-marked UrNCollect device is a unique, user-friendly and compact collection tool that complements the IVD kit by enabling easy and efficient sample collection.
Robustness, reproducibility and interlaboratory performance of SelectMDx was recently published in a technical validation study in Translational Medicine Communications. Urine samples from men scheduled for prostate biopsies due to elevated PSA levels and/or an abnormal digital rectal exam (DRE) or family history of prostate cancer, were tested with SelectMDx. There was less than a two percent difference between the sites’ test results for finding high-grade prostate cancer upon biopsy and samples could be successfully evaluated even after being stored for a year.
Prior studies have validated that SelectMDx predicts the presence of high-grade prostate cancer and helps stratify patients to receive MRI scans or biopsies.
“Many of our current customers are eager to start using the IVD PCR kit so they can run the SelectMDx for Prostate Cancer test in their own labs,” said Dr. Jan Groen, CEO of MDxHealth. “It’s well-timed that our UrNCollect device is launching as a complement to the SelectMDx IVD PCR kit because pilot studies demonstrated that patients and physicians found the device easier to use than traditional urine collection tubes.”
SelectMDx service testing remains available through distribution partners and laboratories that are not equipped to use the IVD PCR kit. Samples are processed at MDxHealth’s state-of-the-art ISO-certified diagnostic facilities in Nijmegen, the Netherlands and Irvine, California, US.
Of the more than 2 million prostate biopsies performed each year in the US and Europe, less than a third find cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated complications and costs. SelectMDx* for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive ‘liquid biopsy’ method to assess a man’s risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce unnecessary MRI procedures and invasive prostate biopsies by approximately 50%, thereby reducing healthcare costs.
MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company’s tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
For more information:
Shalon Roth, EVP Corporate Communications
+44 (0)7393 906278
Ricardo ten Velden, Director Sales & Marketing EMEA
+31 (0) 24 327 94 94
*The SelectMDx IVD PCR kit is not available in all geographies and/or may not be approved for all uses discussed in this press release. It is currently not available for use in the United States.
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. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx, SelectMDx, AssureMDx, PredictMDx and UrNCollect are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.