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A blood test that combines three forms of PSA into one score, to help men with a moderately raised PSA and a normal examination decide whether to have a biopsy.
The FDA approved the Access Hybritech p2PSA assay (Beckman Coulter, PMA P090026) on 14 June 2012. It measures [-2]proPSA, an isoform of free PSA, and is used with the total and free PSA assays to calculate the Beckman Coulter Prostate Health Index (phi), "indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA >= 4.0 to <= 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer". A biopsy is still required for a diagnosis.
Measures [-2]proPSA, a form of free PSA, alongside total and free PSA, and combines them into one index score.
| Region | Year | Indication |
|---|---|---|
| US | 2012 | Aid in distinguishing prostate cancer from benign conditions, men 50 and older with PSA 4 to 10 ng/mL and a non-suspicious rectal examination (PMA P090026) |
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Query for this drug: (TITLE:"Prostate Health Index" OR ABSTRACT:"Prostate Health Index" OR TITLE:"phi, Beckman Coulter" OR ABSTRACT:"phi, Beckman Coulter" OR TITLE:"p2PSA" OR ABSTRACT:"p2PSA" OR TITLE:"Access Hybritech p2PSA" OR ABSTRACT:"Access Hybritech p2PSA" OR TITLE:"[-2]proPSA" OR ABSTRACT:"[-2]proPSA") 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 Prostate Health Index (phi, Beckman Coulter), 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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