There’s a lot riding on
your prostate test…
KNOW THE SCORE.
your prostate test…
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ClarityDX Prostate is a blood-based diagnostic test that 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.
PSA testing alone doesn’t add up.
1 in 8 men will be diagnosed with prostate cancer in their lifetime. The good news is that when detected early, prostate cancer is one of the most successfully treated types of cancer (6).
The challenge is that the current method of screening – 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).
Higher PSA levels can indicate prostate cancer, but they can also be caused by vigorous exercise, recent sexual activity, a prostate infection, etc. In fact, biopsies show most ‘positive’ PSA tests are not indicative of clinically significant prostate cancer (2).
The result is that patients may opt for unnecessary, invasive prostate biopsies and treatments with potentially harmful side effects. There is a better way.
Order your test today
To order the ClarityDXProstate test, please select the province you will get your sample collected from the options below. Then, download the Requisition Package and follow the instructions within.
*ClarityDX Prostate is currently available in Alberta, British Columbia, Ontario, Quebec and Saskatchewan. If your province is not listed, it is not available there yet. We are actively working with testing laboratories to expand availability across Canada.
Up to 80% of men with elevated PSA will have low risk prostate cancer or no prostate cancer.
Better outcomes start from clarity.
When it comes to a cancer diagnosis, clarity means peace of mind. And when it comes to prostate cancer detection, it takes the right data to deliver that clarity.
ClarityDX Prostate is a fast, accessible, clinically-proven diagnostic test that combines multiple data points, including PSA levels, and uses the ClarityDX machine learning platform to calculate a more accurate prostate cancer risk score. It’s a decision-making test to help patients and their physicians determine whether to biopsy after an elevated PSA test result.
ClarityDX Prostate is up to 3X more accurate than PSA alone for predicting aggressive prostate cancer.
ClarityDX Prostate PATIENT JOURNEY
How ClarityDX Prostate works.
The ClarityDX Prostate test uses a proprietary machine-learning algorithm and data from two biological and three clinical biomarkers to generate an accurate risk score for aggressive prostate cancer (3,4).
Because the test can be performed by using lab data from a patient’s PSA blood test, it can be added to the care path with minimal inconvenience to patients and minimal cost to the healthcare system.
ClarityDX Prostate can be utilized at the initial diagnosis stage in the patient care path to inform the decision to biopsy.
Clinical data shows that adding ClarityDX Prostate to the patient care pathway could reduce unnecessary prostate biopsies by up to 35%.
TEST PERFORMANCE*
* Area Under the Curve is used as a quantitative measurement of the accuracy of the diagnostic test.
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CITATIONS & ADDITIONAL NOTES
[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.
[6] Canadian Cancer Statistics Advisory Committee. Canadian Cancer Statistics 2023. Canadian Cancer Society; 2023: https://cancer.ca/en/research/cancer-statistics
[7] Hyndman et al. (2024). npj Digital Medicine 7, 163. 10.1038/s41746-024-01167-9.
[8] Wallis et al. (2024).JCO 42, e17105-e17105. 10.1200/JCO.2024.42.16_suppl.e17105.
[9] Hyndman et al. (2024). Can Urol Assoc J 18 (6Suppl). http://dx.doi.org/10.5489/cuaj.8826MP.
Reference values: The test demonstrated an area under the receiver operating characteristic curve (AUC) of 0.82 and a sensitivity and specificity of 0.95and 0.35, respectively, when using a Risk Score threshold of 25%.
Test performance characteristics : The performance characteristics of ClarityDX Prostate® were determined by Nanostics in a primarily Albertan 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.
Collection site location: Nanostics has an accredited laboratory at 10150 102 Street, Edmonton, AB T5J 5E2 under the College of Physicians and Surgeons of Alberta to perform total PSA, free PSA, and ClarityDX Prostate® tests.