An elevated PSA score doesn't always mean cancer.
The prostate-specific antigen (PSA) test looks at just one data point in a complex equation. The test identifies levels of PSA, a protein made in the prostate, and flags higher levels for prostate cancer risk and further testing, including biopsy. [1]
The issue is that although higher PSA levels can indicate prostate cancer, they can also be caused by vigorous exercise, recent sexual activity, a prostate infection, and more. In fact, studies show that up to 80% of men with elevated PSA level have low risk of prostate cancer, or no prostate cancer. [2]
This may lead to unnecessary invasive prostate biopsies and treatments with potentially harmful side effects.
Clinical data shows that adding ClarityDx Prostate to the patient care pathway could reduce unnecessary prostate biopsies by up to 47%. [5]
The issue is that although higher PSA levels can indicate prostate cancer, they can also be caused by vigorous exercise, recent sexual activity, a prostate infection, and more. In fact, studies show that up to 80% of men with elevated PSA level have low risk of prostate cancer, or no prostate cancer. [2]
This may lead to unnecessary invasive prostate biopsies and treatments with potentially harmful side effects.
Clinical data shows that adding ClarityDx Prostate to the patient care pathway could reduce unnecessary prostate biopsies by up to 47%. [5]
ClarityDx Prostate Outperforms Standard PSA Testing
Note: Area Under the Curve is used as a quantitative measurement of the accuracy of the diagnostic test.
ClarityDx Prostate helps patients and their physicians make informed decisions about treatment.
Key Features of ClarityDx Prostate
A blood based decision support tool that determines the risk of prostate cancer 4x more accurately than PSA alone
Reduces unnecessary biopsies and harmful side effects by up to 47%
Highly accurate and clinically proven diagnostic tool that utilizes machine learning
ClarityDx Prostate provides a risk score based on clinical and biological biomarkers, to help patients and their physicians make an informed decision after an elevated PSA test result.
ClarityDx Prostate is a fast, accessible, clinically-proven decision support tool that combines multiple data points, including PSA levels, and uses the ClarityDX machine learning platform to calculate a more accurate prostate cancer risk score.
ClarityDX Prostate is suitable for patients with abnormal age-specific total PSA and/or abnormal DRE.
This risk score provided by ClarityDX Prostate helps patients and their physicians to determine whether to biopsy after an elevated PSA test result.
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ADDITIONAL NOTES
Reference values: the test demonstrated an area under the receiver operating characteristic curve (AUC) of 0.80 to 0.87 and a sensitivity of 0.95 and specificity of 0.32 to 0.47, when using a Risk Score threshold of 17% or 25%, depending on the information available and the ClarityDX Prostate model used.
Performance characteristics : The performance characteristics of ClarityDX Prostate® were determined by Nanostics in a population 40 to 75 years of age with PSA ≥ 3 ng/mL. Evaluation of this test outside of these ages and PSA values has not been performed by Nanostics. Total PSA and free PSA tests are indicated for men ≥ 50 years of age; caution is required when interpreting individual total PSA and free PSA results in patients below 50 years of age. Patient management should be based on holistic clinical judgment. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA) or Health Canada.
CITATIONS
[1] Wallis et al. (2023).JCO 41, 5023-5023. 10.1200/JCO.2023.41.16_suppl.5023
[2] Moses et al., NCCN Guidelines, V1.2023. https://doi.org/10.6004/jnccn.2023.0014
[3] Bell, et al. CMAJ Nov 2014 186 (16) 1225-1234; DOI: 10.1503/cmaj.140703
[4] Paproski et al. (2023). Eur Urol 83, S91-S92. https://doi.org/10.1016/S0302-2838(23)00119-7
[5] Paproski et al. (2023). Can Urol Assoc J. 17 ((6 Suppl 2)), S117–S118. doi: 10.5489/cuaj.8417