New point of care PSA test … coming soon to your doctor’s office?

According to a media release issued last week by a relatively new company called True Diagnostics, Inc., they hope shortly to be able to introduce a new, “point of care” technical system that can be used to assay PSA levels from a “finger-prick” quantity of blood, thus allowing almost instant assessment of PSA levels in the doctor’s office.

This new method for testing PSA levels (TrueDX™PSA) would certainly facilitate PSA testing, since it would eliminate the need for blood draws and the time involved in sending the blood to a laboratory for testing. However, what we haven’t seen yet are data to suggest that the methodology is as accurate as traditional PSA testing based on such blood draws (which may be needed anyway if you doctor also wants to know things like your cholesterol level or your white blood cell count [WBC] or your blood sugar level).

According to the media release, True Diagnostics has now received a CE Mark (a necessary element in the clinical use of this type of technology) for qualitative and quantitative versions of the TrueDX™PSA test. The qualitative version is only able to tell the doctor if a patient’s PSA value is > 5.0 ng/ml, so the clinical value of this test is limited. By contrast, the quantitative method will be able to assay PSA levels with greater accuracy (although it is not yet clear how much accuracy).

If this test is to become available in the USA, the company is going to need to carry out some relatively simple clinical studies to clearly demonstrate that this new method of assaying PSA levels is accurate and reproducible on a regular basis. Based on the media release, it does look as though the company’s goal is to be able to introduce this methodology in Europe and in North America.

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