FDA approves new type of PSA testing methodology

According to a report on the US Food and Drug Administration (FDA) web site, the FDA has just approved the “finger-prick” Sangia Total PSA blood test developed by OPKO Diagnostics.

It seems likely that many urology practices will be interested in using a method like this for PSA testing over the next couple of years, since it will mean (effectively) instant access to patients’ PSA data at the time of their regular visits — as opposed to the irritating wait required when blood samples have to be sent to outside laboratories for processing.

However, … a lot will depend on the economic factors affecting acquisition of necessary technology and the space required for the testing equipment.

What is unlikely to happen is that you will be able to get such a test at your primary care physicians’ offices.

3 Responses

  1. Suggest you read the Summary of Safety and Effectiveness Data (SSED), included in the link above to the article on the FDA web site.

    This new test certainly appears to be more accurate than the other fingerstick test that has been available for years.

    I am also interested in the cost.

  2. In reply to cost. A 2017, 360 interview with the then-president of their diagnostic unit listed the cost of the unit at $2,500.

    The breakdown was as follows. The Sangia Total PSA Test — P170037 — would cost about $2,500. It would also be available under a reagent rental agreement. The cassettes would cost about $10-$15 per cassette, depending on the test.

    In the press release, the company plans to expand the number of assays performed on the Claros 1 technology platform through future FDA submissions, including a planned submission for a testosterone test later this year.

    Along with the PSA and testosterone tests, they plan on developing assays for conditions such as cardiac disease, oncology, therapeutic drug monitoring, and the detection of other hormones.

  3. Dear John (and others):

    I think we need to be very clear that the cost of acquiring the Claros 1 analyzer is going to be very different from what a physician can bill Medicare (or any other payer) for using that technology platform to implement a Sangia Total PSA test.

    In a very recent presentation to investors in OPKO, there is no mention at all of the acquisition cost or the Claros 1 analyzer or of the cost of the diagnostic cassette necessary for conducting the Sangia Total PSA test.

    There has just been a major change in senior management at OPKO, and until actual data are available it is usually wise to “wait and see” what the actual cost of a new test like this might really be.

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