Image: The UrNCollect device is designed for use with the SelectMDx in vitro diagnostic (IVD) PCR test kit for prostate cancer (Photo courtesy of MDxHealth).
A novel sample collection device was designed to support a urine-based non-invasive "liquid biopsy" molecular diagnostic test that determines the risk for developing high-grade prostate cancer.
The biomedical company MDxHealth SA (Herstal, Belgium) has announced the European launch of its CE-marked UrNCollect device for use with the SelectMDx in vitro diagnostic (IVD) PCR test kit for prostate cancer.
UrNCollect is a user-friendly device that enables the hygienic and standardized collection of the first 16 milliliters of the urine stream and reduces laboratory errors by automating preservative mixing without additional handling or pipetting.
The SelectMDx PCR kit enables diagnostic laboratories with manual and automated RNA extraction and PCR platforms to perform the liquid biopsy test in their own facility. Laboratories that are not equipped to use the IVD PCR kit can have samples processed at MDxHealth’s state-of-the-art ISO-certified diagnostic facilities in Nijmegen, the Netherlands or Irvine, California, USA.
“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 is 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.”
A technical validation study that assessed and confirmed the robustness, reproducibility, and interlaboratory performance of SelectMDx was published in the May 11, 2017, issue of the journal Translational Medicine Communications.