Diagnostic biomarker tests are needed:
  • To identify men at increased risk of harbouring clinically significant cancer who may benefit from earlier diagnosis and treatment
  • To avoid the risk of missing the detection of clinically significant cancer
  • To avoid the number of unnecessary biopsies with associated complications and costs
Flow diagram: biomarkers in biopsy setting

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Table - indirect comparison of diagnostic biomarkers

Development and validation of SelectMDx

SelectMDx was developed and validated in a prospective, multicenter study using 2 independent cohorts of men scheduled for prostate biopsy [2]:

  • Before biopsy, post-DRE urine was collected and mRNA levels of several biomarkers were measured. The combination of HOXC6 and DLX1 had the highest predictive accuracy (AUC 0.76) for high-grade prostate cancer (Gleason score ≥7). From a previous study, it was also shown that these biomarkers have a higher predictive accuracy for high-grade prostate cancer than PCA3 [12].
  • Subsequently, logistic regression models were developed and validated combining the biomarkers with clinical variables (PSA, PSA density, DRE, age, family history and prior biopsy).
  • SelectMDx had a very high predictive accuracy (AUC 0.90) for high-grade prostate cancer, which was significantly better than the Prostate Cancer Prevention Trial (PCPT) risk calculator (AUC 0.77; P=0.015).
98%
NPV (98% certainty of no clinically significant prostate cancer with a negative test result)
2%
Risk of missing high-grade prostate cancer
53%
Of unnecessary biopsies avoided
Flow chart - SelectMDx value for biopsy decisions

How to use SelectMDx?

Instructions for use

To apply the SelectMDx test you have to follow 12 simple steps:

  1. Perform a DRE (3 strokes per lobe) to mobilise the prostate cancer cells and exosomes towards the urethra. Apply enough pressure to slightly depress the prostate surface (it is not intended to be a prostate massage)SelectMDx - how to do it
  2. Collect first voided urine immediately following the DRE. Use the UrNCollect device provided in your SelectMDx Urine Collection kit

  3. Remove the UrNCollect Funnel and Tube from the box

  4. Place the Tube upright on a flat surface and unscrew the cap (do not throw away the cap as it will be used later)

  5. Hold the Funnel upright and screw on the Tube

  6. Instruct the patient to point the spout of the device towards the toilet and urinate into the Funnel; the patient should continue urinating until the bladder is completely empty

  7. Unscrew the Tube from the Funnel. Gently tab floater against the inside of the Tube

  8. Firmly screw the cap onto the Tube and invert the tube 5 times to mix the content

  9. Place the barcode label on the Tube and Test Requisition Form

  10. Place the Tube into the Safety bag

  11. Place the sealed Safety bag with the Test Requisition Form in the SelectMDx Urine Collection kit

  12. Ship the box at ambient temperature as soon as possible after collection (it must reach the laboratory of MDxHealth BV within 5 days of collection)

 

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Contraindications

SelectMDx should be performed only when serum PSA has been determined less than 6 months ago.

 

SelectMDx should be performed only after 3 months in men who had:

  • a prostate biopsy
  • a transurethral resection of the prostate (TURP)

 

SelectMDx should be interpreted with caution in men:

  • taking 5α-reductase inhibitors (e.g. Proscar®, Avodart®)
  • having a urinary tract infection

 

SelectMDx is not influenced by prostatitis and Benign Prostatic Hyperplasia (BPH).

References

1. Loeb S, Vellekoop A, Ahmed HU, et al. Systematic review of complications of prostate biopsy. Eur Urol 2013;64:876-92.

2. Van Neste L, Hendriks RJ, Dijkstra S, et al. Detection of high-grade prostate cancer using a urinary molecular biomarker-based risk score. Eur Urol 2016;70:740-8.

3. 4Kscore Test Characteristics, available at http://4kscore.com/wp-content/uploads/2016/09/Interpreting-your-Results.pdf (last accessed May 2017)

4. Parekh DJ, Punnen S, Sjoberg DD, et al. A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer. Eur Urol 2015;68:464-70.

5. Van Neste L, Partin AW, Stewart GD, et al. Risk score predicts high-grade prostate cancer in DNA-methylation positive, histopathologically negative biopsies. Prostate 2016;76:1078-87.

6. Tomlins SA, Day JR, Lonigro RJ, et al. Urine TMPRSS2:ERG plus PCA3 for individualized prostate cancer risk assessment. Eur Urol 2016;70:45-53.

7. Gittelman M, Hertzman B, Bailen J, et al. PROGENSA®PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: a prospective multicenter clinical study. J Urol 2013;190:64-9.

8. Wei JT, Feng Z, Partin AW, et al. Can urinary PCA3 supplement PSA in the early detection of prostate cancer? J Clin Oncol 2014;32:4066-72.

9. Haese A, de la Taille A, Van Poppel H, et al. Clinical utility of the PCA3 urine assay in European men scheduled for repeat biopsy. Eur Urol 2008;54:1081-8.

10. de la Calle C, Patil D, Wei JT, et al. Multicenter evaluation of the prostate health index to detect aggressive prostate cancer in biopsy naive men. J Urol 2015;194:65-72.

11. Shariat SF, Roehrborn CG. Using biopsy to detect prostate cancer. Rev Urol 2008;10:262-80.

12. Leyten GHJM, Hessels D, Smit FP, et al. Identification of a candidate gene panel for the early diagnosis of prostate cancer. Clin Cancer Res 2015;21:3061-70.