European CE Marketing for In Vitro Diagnostic medical devices (CE-IVD Mark) has been granted to the ClarityDX Prostate test, a biomarker and machine learning–powered test for clinically significant prostate cancer, according to Nanostics Inc., the developer of the test.1
Using a machine-learning algorithm, ClarityDX Prostate assesses a combination of clinical and biological biomarker data and provides a risk score for a patient’s biopsy showing a clinically significant prostate cancer (Gleason grade group ≥2). According to Nanostics, the purpose of ClarityDX Prostate is to serve as a reflex test for helping patients with elevated PSA levels have more informed conversations with their physicians on whether or not to proceed with a biopsy.
The CE-IVD Mark allows ClarityDX Prostate to be marketed throughout the European Economic Area, which encompasses the EU as well as Iceland, Liechtenstein, and Norway.
"We're excited to reach this regulatory milestone for our ClarityDX Prostate test built on our robust biomarker and machine learning platform," John Lewis, CEO of Nanostics, stated in a press release. "Using ClarityDX Prostate as a reflex test for men with elevated PSA levels will help physicians, patients, and their families make more-informed decisions on how best to proceed with prostate cancer screening and result in better health outcomes for men with prostate cancer."1
Earlier this year, Nanostics announced positive results from a pre-biopsy clinical validation study of ClarityDX Prostate.2 The study included 1437 men with elevated PSA levels who were aged 40 to 75 years. The men had all been referred for a prostate biopsy and none had previously been diagnosed with prostate cancer.
According to Nanostics, “Algorithmic risk models to predict prostate cancer or clinically significant (grade group ≥2) prostate cancer were generated using data from 1036 men recruited at the Kipnes Urology Center in Edmonton, AB, and a site in Baltimore, USA. These models were then tested in a validation cohort of 401 men recruited at the Prostate Cancer Center in Calgary, AB.”2
The study results showed that ClarityDX Prostate had 94% sensitivity, 37% specificity, 49% positive predictive value, and 90% negative predictive value for predicting clinically significant prostate cancer, defined as Gleason grade group 2 or higher. The researchers also concluded that use of ClarityDX Prostate had the potential to avoid 37% of unnecessary biopsies and help alleviate the overtreatment of prostate cancer.
“The results from the study are being submitted for peer-reviewed publication. Beyond the immediate cost savings to the healthcare system, the launch of the ClarityDX Prostatetest will positively impact the overall healthcare experience and quality of life for men with prostate cancer,” according to Nanostics.2
1. Nanostics Receives CE Mark for its ClarityDX Prostate® Test to Detect Clinically Significant Prostate Cancer. Published online August 23, 2022. Accessed August 23, 2022. https://prn.to/3AGRdf5
2. Nanostics Announces Study Data Supporting ClarityDX Prostate as a Reflex Test to Predict Clinically Significant Prostate Cancer. Published online June 30, 2022. Accessed August 23, 2022. https://prn.to/3T5HEgZ