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PROSTATE CANCER

First point-of-care PSA test for prostate cancer detection

The FDA’s approval of the first point-of-care total PSA test for prostate cancer has the potential to improve patient care by streamlining PSA testing. However, a Clinical Laboratory Improvement Amendments waiver is needed before this test can be fully integrated into clinical care.

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References

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    U.S. Food and Drug Administration. Recently-approved devices: Sangia Total PSA Test - P170037. FDA https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm630197.htm (updated 31 Jan 2019).

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    U.S. Food and Drug Administration. Summary of safety and effectiveness data (SSED). FDA https://www.accessdata.fda.gov/cdrh_docs/pdf17/p170037b.pdf (2019).

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    OPKO Diagnostics. Instructions for use. FDA https://www.accessdata.fda.gov/cdrh_docs/pdf17/p170037c.pdf (2019).

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    Loeb, S. et al. How active is active surveillance? Intensity of followup during active surveillance for prostate cancer in the United States. J. Urol. 196, 721–726 (2016).

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    Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments (CLIA). CMS https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia (updated 24 Feb 2019).

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    Centers for Medicare & Medicaid Services. How to obtain a CLIA certificate of waiver. CMS https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCertificateofWaiver.pdf (2006).

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Competing interests

The authors declare no competing interests.

Correspondence to Michael A. Gorin.

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Fig. 1: A microfluidic-based immunoassay employing Sangia technology.