# Prostate Health Index (phi, Beckman Coulter)

Source: https://onco.cc/drugs/prostate-health-index/  
OnCo record `prostate-health-index` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Also known as: Prostate Health Index; p2PSA; Access Hybritech p2PSA; [-2]proPSA
- Tags: test; screening-test
- Brand: phi
- Modality: Blood test combining three PSA measurements into an index
- Mechanism: Measures [-2]proPSA, a form of free PSA, alongside total and free PSA, and combines them into one index score.
- Approvals: 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)

## Sources

- FDA PMA P090026: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090026

## Connected records

- drugs: [4Kscore Test (OPKO Health)](https://onco.cc/drugs/4kscore/), [IsoPSA Assay (Cleveland Diagnostics)](https://onco.cc/drugs/isopsa/), [Progensa PCA3 Assay](https://onco.cc/drugs/progensa-pca3/)
- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [PSA and MRI-first prostate cancer screening](https://onco.cc/technologies/prostate-screening-psa-mri/)
- companies: [Beckman Coulter](https://onco.cc/companies/beckman-coulter/)
- terms: [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/), [Screening](https://onco.cc/terms/screening/)

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JSON: https://onco.cc/api/v1/entities/prostate-health-index.json