Breakthrough Device Designation for miR Sentinel™ urine test


According to a media release issued on Tuesday this week by miR Scientific, the US Food and Drug Administration (FDA) has issued a Breakthrough Device Designation for the company’s new urine-based test for risk of prostate cancer (the miR Sentinel™ Prostate Test). The FDA’s Breakthrough Device Designation allows for accelerated approval of novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

We have previously reported on the potential value of this test in the early assessment of categorizable forms of prostate cancer and their risk. We hope to see this product become widely available in the relatively near future for a variety of potential applications in the diagnosis and management of prostate cancer.

5 Responses

  1. Mike,

    Where would you see this test fitting into the healthcare ecosystem? Based on the pricing of another liquid biopsy test that requires sequencing of DNA/RNA material I am guessing that this test will likely cost at least $1200. Would that be practical for insurance companies and Medicare to cover as an annual screen for men over 60? Or, do you see it only being used in place of a biopsy, say after an elevated PSA or suspicions raised by a DRE?

    Thanks for your educated opinion.

  2. Dear Douglas:

    At least initially, I suspect that the most appropriate way to be using this test will be prior to a biopsy for a man who has slightly elevated PSA level of (say) between 2.5 and 10 ng/ml. I also suspect that this test may have great value in replacing MRIs and biopsies as a way to monitor men on active surveillance. However, we are going to have to see what the FDA says before we can get any idea of how insurance companies and other payers (Medicare) will look at a test like this, and additional study data will also be essential to further validate the accuracy of a test like this.

  3. I, for one, would appreciate an immediate update once the FDA status of this test changes. I would be willing to pay NOT to have a biopsy, as I have the prerequisite PSA and DRE. BTW, I have written to miR Scientific (over 5 weeks ago) and received no reply.

  4. Dear CHP:

    It is my understanding that it is impossible for miR Scientific to make this test available (except through this clinical trial) until the FDA has ruled on the status of this test — which I would expect to happen relatively early in the new year. The previously mentioned trial is enrolling patients at centers in New York state and Georgia.

    What I can tell you, however, is that a lot of physicians are also very interested in being able to use this test as soon as it becomes available … particularly in men like you who may not need a biopsy if the test shows that they have no prostate cancer or only a low-risk form of prostate cancer.

    You might want to do two things in particular: (1) watch the media releases on the company’s web site, because they will most certainly be the first to tell everyone once there is a ruling from the FDA and (2) make sure your own doctor knows you want this test so that he can be sure to set up appropriate arrangements with miR Scientific in advance.

  5. Thank you. miR has a contact form which I used today to stay informed. You can subscribe to an e-mail list there as well.

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