MDxHealth SA, Herstal, Belgium, has launched the SelectMDx for Prostate Cancer in vitro diagnostic (IVD) polymerase chain reaction (PCR) kit with CE-marked components, including the complementary UrNCollec device, in Europe and other markets.
The kit will enable diagnostic laboratories with manual and automated RNA extraction and PCR platforms to perform the SelectMDx liquid biopsy test in their own facilities. The UrNCollect device is a user-friendly, compact collection tool that complements the IVD kit by enabling easy and efficient sample collection.
In a recent multisite study, investigators used the SelectMDx kit to test urine samples from men scheduled for prostate biopsies due to elevated prostate-specific antigen levels, an abnormal digital rectal exam, or family history of prostate cancer.1 There was less than a 2% 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.
Jan Groen, PhD, MDxHealth.
“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,” says Jan Groen, PhD, 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 for laboratories that are not equipped to use the kit. Samples are processed at MDxHealth’s diagnostic facilities in Nijmegen, the Netherlands, and Irvine, Calif.
For more information, visit SelectMDx.
REFERENCE
- Hessels D, de Jong H, Jannink SA, et al. Analytical validation of an mRNA-based urine test to predict the presence of high-grade prostate cancer. Trans Med Comm. 2017;2(1):5; doi: 10.1186/s41231-017-0014-8.
