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A blood test approved by the FDA in November 2025 to help decide on a prostate biopsy in men 50 and older with a PSA between 4 and 10.
The IsoPSA Assay (Cleveland Diagnostics, PMA P200048) was approved by the FDA on 28 November 2025. It combines total PSA and free PSA results (Roche Elecsys) from partitioned heparinised plasma into a single numerical index and is indicated, with other patient information, "to aid in detection of high-grade prostate cancer (Grade Group >= 2; Gleason score >= 7) in men >= 50 years of age, with total PSA levels >= 4.0 to =< 10.0 ng/mL for whom a biopsy is being considered by a urologist". A biopsy is still required for a diagnosis.
Partitions PSA in plasma and combines total and free PSA results into a single numerical index associated with high-grade cancer.
PMA P200048 approved source
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Aid in detecting Grade Group 2 or higher prostate cancer, men 50 and older with PSA 4 to 10 ng/mL (PMA P200048) |
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Query for this drug: (TITLE:"IsoPSA Assay" OR ABSTRACT:"IsoPSA Assay" OR TITLE:"Cleveland Diagnostics" OR ABSTRACT:"Cleveland Diagnostics" OR TITLE:"IsoPSA" OR ABSTRACT:"IsoPSA") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about IsoPSA Assay (Cleveland Diagnostics), not a curated reading list.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
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