Abstract
Background: A more accurate diagnostic test is still needed to enhance decision-making regarding prostate biopsy. MiCheck is a triage test to assist in a decision to proceed to prostate biopsy. It measures multiple cancer related proteins in blood while combining this information with clinical factors. It has been optimised to differentiate between aggressive (AgCaP) and non-aggressive (non-AgCaP) prostate cancer. The MiCheck-01 clinical trial collected samples from patients who proceeded to biopsy on the basis of an elevated age adjusted PSA. The performance of MiCheck was compared with PSA, %free PSA and PHI.
Methods: Serum samples were tested according to the MiCheck manufacturer's instructions. Patient samples were also tested using a standard PSA assay and additionally underwent PHI and % free PSA measurement. A range of different MiCheck cutpoints were examined for test performance and one chosen following consultation with Urologists and Clinical Chemists. This algorithm was applied to all evaluable patients from the trial and the outputs used for the development of a health economic model. The net cost impact of using MiCheck was assessed.
Results: The best performing MiCheck algorithm demonstrated a high AUC when differentiating AgCaP from non-AgCaP. MiCheck demonstrated a higher AUC than PSA, %free PSA and PHI in this population. Furthermore, the algorithm was superior to the other tests in PSA 4-10ng/ml range. The derived algorithm was applied to patients from the trial using a high sensitivity cutpoint. At this cutpoint, 25% of biopsies were avoided while only 5 (4%) AgCaP patients underwent a later diagnosis. A diagnostic workflow model of how the test might be employed by the clinician was constructed. This was applied to a health economic analysis demonstrating significant cost savings (between 2,744 and 5,047 per patient in year one) when incorporating MiCheck to standard of care.
Conclusions: The MiCheck test demonstrates a superior ability to discriminate between AgCaP and non-AgCaP in comparison to PSA,PHI, and % free PSA. Use of the MiCheck test would assist clinicians in assessing the need for a prostate biopsy and provide significant healthcare cost savings.
Methods: Serum samples were tested according to the MiCheck manufacturer's instructions. Patient samples were also tested using a standard PSA assay and additionally underwent PHI and % free PSA measurement. A range of different MiCheck cutpoints were examined for test performance and one chosen following consultation with Urologists and Clinical Chemists. This algorithm was applied to all evaluable patients from the trial and the outputs used for the development of a health economic model. The net cost impact of using MiCheck was assessed.
Results: The best performing MiCheck algorithm demonstrated a high AUC when differentiating AgCaP from non-AgCaP. MiCheck demonstrated a higher AUC than PSA, %free PSA and PHI in this population. Furthermore, the algorithm was superior to the other tests in PSA 4-10ng/ml range. The derived algorithm was applied to patients from the trial using a high sensitivity cutpoint. At this cutpoint, 25% of biopsies were avoided while only 5 (4%) AgCaP patients underwent a later diagnosis. A diagnostic workflow model of how the test might be employed by the clinician was constructed. This was applied to a health economic analysis demonstrating significant cost savings (between 2,744 and 5,047 per patient in year one) when incorporating MiCheck to standard of care.
Conclusions: The MiCheck test demonstrates a superior ability to discriminate between AgCaP and non-AgCaP in comparison to PSA,PHI, and % free PSA. Use of the MiCheck test would assist clinicians in assessing the need for a prostate biopsy and provide significant healthcare cost savings.
| Original language | English |
|---|---|
| Pages | 199 |
| Number of pages | 1 |
| DOIs | |
| Publication status | Published - 2019 |
| Externally published | Yes |
| Event | 2019 Genitourinary Cancers Symposium - San Francisco, United States Duration: 14 Feb 2019 → 16 Feb 2019 |
Conference
| Conference | 2019 Genitourinary Cancers Symposium |
|---|---|
| Country/Territory | United States |
| City | San Francisco |
| Period | 14/02/19 → 16/02/19 |