AssureMDx for Bladder Cancer Test

Liquid Biopsy AssureMDx - MDxHealth

AssureMDx for Bladder Cancer is a noninvasive liquid biopsy test to aid in the decision for cystoscopy.

The test combines epigenetic and mutation biomarkers with the addition of clinical risk factors to help determine a patient's risk of having bladder cancer detected upon cystocopy.

The test helps healthcare professionals:

  • Identify patients at increased risk for bladder cancer who may benefit from cystoscopy
  • Gain piece of mind for patients at low risk for bladder cancer

AssureMDx Assay Performance

AssureMDx Sensitivity Chart  

 Performance by Tumor Grade

Bladder Tumor Sensitivity Specificity NPV (10% prev) PPV (10% prev) NPV (5% prev) PPV (5%) AUC Odds Ratio
Ta 88.60 89.40 98.60 48.20 99.30 30.60 93.50 65.60
T1 91.70 94.40 99.00 64.50 99.50 46.30 97.50 185.80
T2-T4 92.30 95.70 99.10 70.50 99.60 53.00 94.10 264.00
Low Grade (G1 & G2) 85.50 90.10 98.20 49.00 99.20 31.30 93.90 53.50
High Grade (G3) 93.50 92.50 99.20 58.10 99.60 39.60 96.50 180.00

Background-Unmet Clinical Need

Each year in the United States, it is estimated that nearly 11 million patients are referred to a urologist for clinical evaluation due to hematuria (blood in urine). Hematuria is the most common symptom of bladder cancer, yet only 3% to 28% of hematuria patients are diagnosed with bladder cancer. The current standard of care for bladder cancer diagnosis is a cystoscopy, which is an invasive procedure where a cystoscope is inserted into the patient’s urethra to visualize the bladder wall and to perform a biopsy if a lesion is identified. However, given the low prevalence of bladder cancer, the vast majority of hematuria patients could avoid the unnecessary discomfort and cost of cystoscopy, if cancer could be ruled out by a less intrusive method. 

Chart Background

AssureMDx 

AssureMDx is a non-invasive, urine-based test, combining methylation and mutation biomarkers, to assess the risk of bladder cancer for patients diagnosed with hematuria. AssureMDx has been validated to improve upon the standard of care, helping rule out the risk of bladder cancer with a negative predictive value (NPV) of 99%. The high NPV led study investigators to report that the test could potentially spare as many as 77% of hematuria patients from undergoing cystoscopy unncessarily. Furthermore, the test’s 93% sensitivity and 85% specificity can help doctors identify patients at increased risk for bladder cancer, who may benefit from cystoscopy. 

AssureMDx Provides Actionable Results

AssureMDx Decision Tree

How AssureMDx Works

The test uses methylation specific PCR (MSP to assess the DNA methylation status of  OTX1, ONECUT2 and TWIST1 in combination with next generation sequencing (NGS) to determine the somatic statuses  in FGFR3, TERT and HRAS for the detection of bladder cancer in urine. The methlyation results are combined with patient's demographic information in a clinically validated model to generate a personalized risk profile. When the risk surpasses critical threshold, the patient result is reported POSITIVE; otherwise the patient is reported as NEGATIVE.

References

1. David SA, et al; Urology 2017 Feb;100:20-26

2. Kessel K, et al; Journal of Urology 2017 Mar; 197(3): 590-595

3. Kessel K, et al; Journal of Urology 2016; Mar; 195(3): 601-7