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.

2 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.

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