There’s a lot riding on
your prostate test…

KNOW THE SCORE.

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 6 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.

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.

ClarityDX Prostate Physician Pack

ClarityDX Prostate Physician Brochure

ClarityDX Prostate Patient Pack

ClarityDX Prostate Patient Brochure

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.

FAQ

About the ClarityDX Prostate test:

ClarityDX Prostate is an easy, quick, and non-invasive reflex blood test that accurately predicts clinically significant (aggressive) prostate cancer after an abnormal PSA and/or digital rectal exam (DRE). When the patient receives their ClarityDX Prostate test result they should talk to their doctor to decide on the next steps to take for prostate cancer management.

The ClarityDX Prostate test result provides you and your physician with the probability of finding clinically significant, aggressive prostate cancer if a prostate biopsy were to be performed. Using the risk score generated from this blood test, you and your physician can make better-informed healthcare decisions.

A validation study with five independent cohorts totaling 3,448 men, showed that ClarityDX Prostate is 3X more accurate than PSA at detecting clinically significant prostate cancer. This improved accuracy can be used to better inform clinical decision-making on whether to proceed to prostate biopsy and/or magnetic resonance imaging (MRI).

ClarityDX Prostate is a laboratory-developed test by Nanostics that combines the lab results of two biomarkers (total PSA and free PSA) and three clinical features (age, previous negative prostate biopsy status, and digital rectal exam findings) to calculate the risk of having clinically significant prostate cancer, defined as Gleason Grade Group 2 or higher, on prostate biopsy.

The risk score is a percent probability ranging between 0.1% to 99.9% of clinically significant prostate cancer and is reported with the patient’s risk percentile associated with their age group. A risk score of 25% or above indicates a high-risk percentile for clinically significant prostate cancer.

A high Clarity DX Prostate risk score means that follow-up is recommended. This follow-up, determined by you and your physician, could include a digital rectal examination (DRE), magnetic resonance imaging (MRI), or a prostate biopsy.

The ClarityDX Prostate test does not diagnose prostate cancer. It is used after an abnormal PSA or DRE screening test to assist in the biopsy decision. The ClarityDX Prostate test assesses the probability of finding aggressive prostate cancer if you were to have a biopsy.

ClarityDX Prostate is a laboratory-developed test that is performed in Nanostics’ College of Physicians and Surgeons of Alberta (CPSA) accredited laboratory registration #L0526000. CPSA is the organization that performs medical service approvals for Alberta Health Services. In Canada, laboratory-developed tests offered as services are regulated by the provinces, rather than Health Canada.

ClarityDX Prostate is currently available as a private pay test and is not covered by local health authorities. It may be eligible for reimbursement through your employer’s health spending account.

Yes. The biomarkers utilized in ClarityDX Prostate have been researched by scientists at leading international cancer research centers for multiple decades. The accuracy and reliability of the ClarityDX Prostate test has been shown in clinical studies involving more than 3400 men.

The ClarityDX Prostate test was validated in a large and contemporary multi-site prospective study that included men from Canada, the US, and Czechia. We have published peer-reviewed articles in leading medical journals on the clinical effectiveness of the ClarityDX platform technology and the ClarityDX Prostate test.

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.

Reference values:
The test demonstrated an area under the receiver operating characteristic curve (AUC) of 0.82 and a sensitivity and specificity of 0.95 and 0.35, respectively, when using a Risk Score threshold of 25%.

Taking the ClarityDX Prostate test:

Patients must be between 40-75 years of age with total PSA ≥ 3 ng/mL and without a prior diagnosis of prostate cancer. Nanostics always recommends discussing screening options with your physician.

No, the patient must not have been previously diagnosed with prostate cancer. This test has not been evaluated in men who have had prostate cancer therapy in the past year or who have had a prior cancer diagnosis.

ClarityDX Prostate is currently available in select provinces across Canada. We will be expanding availability to other regions in Canada, the US, and Europe soon. Healthcare providers located in a province where ClarityDX Prostate is available can order the ClarityDX Prostate test. Contact your healthcare provider for more information about ClarityDX Prostate®.

ClarityDX Prostate is a simple blood test, no patient preparation is required.

Men with elevated levels of PSA will be prescribed ClarityDX Prostate, and the patient will go to a collection site to provide a blood sample. For example, in Alberta, the patient will go to an Alberta Precision Labs (including those formerly offered by DynaLIFE ) collection site. The blood sample is then sent to Nanostics’ accredited laboratory for processing and analysis. A report is generated with a risk score that indicates the likelihood of finding clinically significant prostate cancer with a prostate biopsy. The results are sent to the requesting physician, who will contact the patient regarding any needed follow-up.

Your healthcare provider will receive the results and share them with you. You can also request that the results be sent directly to you by completing the Request Form (click here for a link to this form) and emailing it to the CPSA-accredited laboratory with proof of identity.

It is important to follow recommended prostate cancer screening guidelines. Patients should discuss risk factors and screening frequency with their physician.

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    CITATIONS & ADDITIONAL NOTES

    [1] Mason et al., Update-2022 CUA. 16(4):E184-96. http://dx.doi.org/10.5489/cuaj.7851
    [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] Darren R. Brenner et al., CMAJ 2022 May 2;194:E601-7.doi: 10.1503/cmaj.212097
    [5] Darren R. Brenner et al., CMAJ 2022 May 2;194:E601-7.doi: 10.1503/cmaj.212

    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.