PSA is 2.65, and Exosomedx 35.8, should I be scheduled for biopsy?

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Should I be concerned?

5 Answers

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To the best of my knowledge, exosomedx has not been approved by the FDA.

Your PSA level is within the normal range (<4ng/ml). Traditionally, your risk for prostate cancer is low. However, your exosomedx result is high, meaning possibility of prostate cancer. According to the information provided by the company, the test is intended for men of ≥ 50 years of age with a PSA level of between 2 and 10 ng/ml. Basically, the lower the value, the lower probability for high-grade disease on an initial biopsy.

So, basically your PSA result contradicts with your exosomedx result. Your best management should be made by your treating urologist.
How old are you? Your PSA level is OK.

Using a proprietary algorithm that combines the relative weighted expression of the three-gene signature, the Exosomedx test assigns an individual risk score for patients ranging from 0 to 100. A score >15.6 is associated with an increased likelihood of high-grade prostate cancer on a subsequent biopsy.

Therefore, based on the Exosomedx test, you’d better have a prostate biopsy.
I'm 66, the urine test is fairly new, what is it's accuracy. PSA has never been high,and rectal exam always negative.
There are still no results posted on clinicaltrials.gov website about the utility of the test. And, the cut-point score (of 15.6) was optimized to increase the probability of finding clinically (more) significant high-grade disease, so a percentage of men with low-grade and benign biopsies will have false positive results using this test.
In a large clinical validation study, ExoDx Prostate demonstrated a statistically significant improvement in the ability to accurately predict high-grade prostate cancer in men presenting for an initial biopsy when added to the standard of care versus standard of care alone (JAMA Oncology, P Carroll et al, July 2016).
Your PSA level is OK. What is the result of ultrasound for prostate? Are there other imaging tests done? Do you have symptoms or a family history?

The Exosomedx test assigns an individual risk score for patients ranging from 0 to 100. A score >15.6 is associated with an increased likelihood of high-grade prostate cancer on a subsequent biopsy. Therefore, based on the Exosomedx test, you should have a prostate biopsy. You'd better see a urologists to comprehensively assess your condition.
I did  PSA and my PSA was 1.4. However, I also did a CT examination and the result is not good and I was asked to have a prostate biopsy. My PSA level is normal, but I still have risk of prostate diseases. The result of exosomedx is not good. I think you need to do a  biopsy.
I had the Exosomedx last month. My PSA is 3.2, then the doctor asked me to do the Exosomedx, proved to be 39. For accuracy, I dis biopsy as well. However, the result remained. Later, I learned many patients in my wardroom had the same experience like me. Thus, I think the test is accurate.
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