There’s a lot riding on
your prostate health…

KNOW THE SCORE.

ClarityDX Prostate uses clinical and blood-based biomarkers to determine a patient’s risk of having clinically significant prostate cancer to help patients and their physicians make more informed healthcare decisions.

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 clinically proven decision support tool that uses a machine learning platform to calculate an accurate prostate cancer risk score from clinical data and multiple blood-based PSA test results (5-7).

If you have an elevated PSA, or a suspicion of prostate cancer, ClarityDX Prostate may be right for you. ClarityDX Prostate takes the fear and uncertainty out of prostate cancer screening.

Order ClarityDX Prostate Today

To order the ClarityDX Prostate, please select the province where you will get your blood 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, Saskatchewan and Quebec. If your province is not listed, it is not available there yet. We are actively working with sample collection laboratories to expand availability across Canada.

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 (1).

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 measures levels of PSA, a protein made in the prostate, and flags higher levels for prostate cancer risk and further testing, including biopsy (2-4).

Elevated PSA levels can indicate prostate cancer, but these higher levels 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 on their own (2-4).

The result is that patients may opt for unnecessary, invasive prostate biopsies and treatments with potentially harmful side effects. There is a better way.

I am so supportive of this whole thing because I’ve been living it! My PSA had been creeping up on my annual civil aviation blood work and in discussing it with my doctor, I was wary of any invasive procedures unless absolutely necessary. Through my participation in the Edmonton Motorcycle Ride For Dad, I was aware that the ClarityDX Blood would soon be available. I was pleased to be among the first thirty or so tested in October of 2023. The ClarityDX Blood test was so easy and it provided a significant risk score which I found helpful, as did both of the Urologists that I ended up seeing because of it. We were all more confident in the next steps because of ClarityDX Prostate.

JB, Patient

The study published in NPJ Digital Medicine on June 20 2024 shows that ClarityDX Prostate is accurate at predicting if the patient has grade group 2 and above prostate cancer. Using this as an adjunctive test after PSA screening will give physicians more information to help decide if their patient should undergo a prostate biopsy or not.

Dr. Eric HyndmanDr. Eric Hyndman, Urologist and Chief Medical Officer at Nanostics

We are very happy that we can now bring a powerful tool in prostate cancer screening to men and their healthcare providers in Alberta, British Columbia, Quebec, Ontario, and Saskatchewan. When a doctor orders this test for their patient, they will receive accurate information about his risk of aggressive prostate cancer, helping make informed treatment decisions and avoid unnecessary invasive prostate biopsies.

Dr. John LewisDr. John Lewis, CEO of Nanostics and Bird Dogs Chair of Translational Oncology

ClarityDX Prostate Patient Journey

Prostate Cancer Pathway

How does ClarityDX Prostate work?

ClarityDX Prostate uses a proprietary machine-learning algorithm and data from two blood-based biological markers with up to five clinical biomarkers to generate an accurate risk score for aggressive prostate cancer (5-7).

Because ClarityDX Prostate uses lab data from a patient’s PSA blood test, it can be added to the healthcare pathway with minimal inconvenience to patients and low cost to the healthcare system.

ClarityDX Prostate can be utilized at multiple stages in the patient care path to inform the decision to biopsy.

ClarityDX Performance

Performance characteristics for ClarityDX Prostate models using up to five clinical features for predicting grade group 2 and above prostate cancer:

ClarityDX Prostate Test Performance

**AUC: Area Under the Curve is used as a quantitative measurement of accuracy.

Frequently Asked Questions

What is ClarityDX Prostate?

ClarityDX Prostate is a decision support tool that accurately predicts clinically significant (aggressive) prostate cancer after an abnormal PSA or a suspicion of prostate cancer. When the patient receives their ClarityDX Prostate result they should talk to their healthcare provider to decide on the next steps to take for prostate cancer management.

ClarityDX Prostate provides you and your healthcare provider with the probability of finding clinically significant, aggressive prostate cancer if a prostate biopsy were to be performed. You and your healthcare provider can make better-informed healthcare decisions using the ClarityDX Prostate Risk Score.

A validation study with five independent cohorts totalling 3,448 men, showed that ClarityDX Prostate is up to 4X more accurate than PSA at predicting individuals without aggressive prostate cancer. This improved accuracy can be used to better inform clinical decision-making on whether to proceed to prostate biopsy (5).

ClarityDX Prostate combines the lab results of two blood-based biomarkers (total PSA and free PSA) and up to five clinical features (age, previous negative prostate biopsy status, digital rectal exam findings, prostate volume, and PI-RADS) to calculate the risk of having clinically significant prostate cancer, defined as Gleason Grade Group 2 or higher, on prostate biopsy (3-8).

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 high Clarity DX Prostate Risk Score means that follow-up is recommended. This follow-up, determined by you and your healthcare provider, may include magnetic resonance imaging (MRI) and/or a prostate biopsy.

ClarityDX Prostate does not diagnose prostate cancer. It is used after an abnormal PSA test, or other suspicion of prostate cancer to assist in the biopsy and/or MRI decision. ClarityDX Prostate assesses the probability of finding aggressive prostate cancer if you were to have a biopsy.

ClarityDX Prostate is a Decision Support Tool that uses clinically proven biomarkers through 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.

It is not approved by Health Canada or the FDA.

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, biomarkers utilized in ClarityDX Prostate have been researched by scientists at leading international cancer research centers for many decades.

ClarityDX Prostate was validated in a large and contemporary multi-site prospective study that included men from Canada, the US, and Czechia. The results have been published peer-reviewed articles in leading medical journals on the clinical effectiveness of ClarityDX Prostate (5-7).

Taking ClarityDX Prostate:

Men with clinical suspicion of having prostate cancer (elevated PSA, abnormal DRE, or symptoms) and without a prior diagnosis of prostate cancer. Nanostics always recommends discussing screening options with your healthcare provider.

No, if the patient has already been diagnosed with prostate cancer ClarityDX Prostate cannot add further value.

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®.

No patient preparation is required to take ClarityDX Prostate.

Men with elevated levels of PSA or suspicion of prostate cancer can be prescribed ClarityDX Prostate, and the patient will go to a collection site to provide a blood sample. The blood sample will be used to measure total and free PSA and the clinical features will be incorporated with the lab results to determine the risk score. 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 healthcare provider, 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 contact Nanostics by email at [email protected] or by telephone at 1-800-672-2027, press 1 to connect with the Clinical Laboratory.

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

Other FAQs:

The proportion of patients without the disease or outcome who are correctly predicted.

The proportion of patients with the disease or outcome who are correctly predicted.

When applied to early diagnosis and screening for prostate cancer, the proportion of free PSA can be used in conjunction with other factors to reduce the number of false-positive results by 20-40%. When testing the ClarityDX Prostate model by removing components one by one, removing the percentage of free PSA had the greatest effect, which showed its strong contribution to the model.

ClarityDX Prostate is more accurate than other single biomarker tests, such as total PSA, to predict clinically significant prostate cancer (grade group ≥2) since it combines laboratory and clinical information including total PSA, free PSA, age, and prior prostate biopsy results. Additional information such as digital rectal exam findings, prostate volume, and PI-RADS score may be used for higher accuracy if the information is available.

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    CITATIONS & ADDITIONAL NOTES

    1) Sung et al. (2021) Cancer J. Clin. 71, 209–249.

    2) Dickinson et al (2016) CMAJ Open 4:E73-E79.

    3) McLaughlin et al: (2024) Scientific Reports 14:5810.

    4) Van Poppel et al: (2022) Nature Reviews Urology 19:562-572.

    5) Hyndman et al. (2024) npj Digital Medicine 7, 163. 10.1038/s41746-024-01167-9.

    6) Wallis et al. (2024) .JCO 42, e17105-e17105. https://ascopubs.org/doi/abs/10.1200/JCO.2024.42.16_suppl.e17105

    7) Hyndman et al. (2024) Can Urol Assoc J 18 (6Suppl). doi.org/10.5489/cuaj.8826 MP 1.13

    DISCLAIMER

    The performance characteristics of ClarityDX Prostate were determined by Nanostics in a population primarily between 40 to 75 years of age with PSA ≥3 ng/mL. PSA and free PSA tests are indicated for men between ≥50 years of age; caution required when interpreting individual PSA and free PSA results in patients below 50 years of age. Accuracy may be influenced by PSA-altering drugs such as 5-alpha reductase inhibitors. Patient management should be based on holistic clinical judgment. ClarityDX Prostate has not been cleared or approved by the U.S. Food and Drug Administration (FDA) or Health Canada. ClarityDX Prostate is intended to aid physicians in the decision for subsequent diagnostic testing such as prostate biopsy or imaging.

    CPSA Accredited Laboratory

    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® measurements.