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MDxHealth Launches CE-Marked SelectMDx IVD PCR Kit and UrNCollect Device
publication date: Jul 7, 2017
MDxHealth SA (Euronext: MDXH.BR) have 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™ 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.