MDxHealth announced the launch of the SelectMDx® in vitro diagnostic (IVD) PCR kit for Prostate Cancer with CE-marked components and CE-marked UrNCollect device in Europe and other non-US markets.
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.
Read more on IVD in the dedicated BioVox white paper.
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.
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."
Read more on MDx Health.