There’s a lot riding on
your prostate test…

KNOW THE SCORE.

Clarity DX 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.

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*

1 – AUC is used as a quantitative measurement of the accuracy of the diagnostic test.
2 – Sensitivity is the accuracy of detecting people with aggressive prostate cancer.
3 – Specificity is the accuracy of detecting people without aggressive prostate cancer.
4 – PPV is the accuracy of tests providing high-risk predictions.
5 – NPV is the accuracy of tests providing low-risk predictions.

FAQ

TAKING 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.

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 Alberta, Canada. We will be expanding availability to other regions in Canada, the US, and Europe soon. Alberta Physicians can order the ClarityDX Prostate test. Contact your physician for more information about The ClarityDX Prostate® test.

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.

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

The prescribing/requisitioning physician will receive the patient’s ClarityDX Prostate® test result within five (5) business days from the time our laboratory receives their blood sample. The prescribing/requisitioning physician will contact the patient to discuss the ClarityDX Prostate test result and options for the next steps regarding their prostate health.

ClarityDX Prostate patient reports are only sent to the prescribing/requisitioning physician. Forwarding patient reports to other physicians or the patient is the responsibility of the prescribing/requisitioning physician.

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.

Clarity DX Prostate is currently available as a private pay test and is not covered by Alberta Health. 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.

ADDITIONAL INFORMATION:

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%.

The requisitioning physician will receive your ClarityDX Prostate test result within five (5) business days from the time our laboratory receives your blood sample. Your physician will contact you to discuss your ClarityDX Prostate® test result and options for the next steps regarding your prostate health.

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

Bring your requisition to any Alberta Precision Lab collection sites in the province of Alberta (including those formerly offered by DynaLIFE).

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.

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CITATIONS

  • (1) Mason et al. 2022. Can Urol Assoc J. 16(4)
  • (2) Brenner et al. 2022. CMAJ. 194 (17)
  • (3) Paproski et al. 2023. Eur Urol. 83. Suppl 1
  • (4] Wallis et al. 2023. JCO. 41. 5023-5023