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TEST:
ClarityDX Prostate®

Company:
Nanostics
Type:
CE Marked
Evidence

News

4ms
APCaRI-05: Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer (clinicaltrials.gov)
P=N/A; Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Mar 2024
Trial completion date • Trial primary completion date • Enrollment closed • Reflex
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ClarityDX Prostate®
7ms
Nanostics launches ClarityDX prostate test in Alberta to Significantly improve prostate cancer screening (Nanostics Press Release)
"Nanostics is thrilled to announce the availability of the ClarityDX Prostate test at its newly accredited clinical lab in Edmonton, Alberta. This innovative blood test marks a significant advancement in prostate cancer screening. It provides critical support to men, aged 40 to 75, and their physicians in making more informed decisions, with 3X the accuracy, about whether a biopsy is required following a high prostate-specific antigen (PSA) test result."
Commercial
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ClarityDX Prostate®
7ms
Nanostics receives provisional CPSA accreditation for its clinical laboratory (BioSpace)
"Nanostics Inc...announced today that the College of Physicians and Surgeons of Alberta (CPSA) granted provisional accreditation to Nanostics Clinical Laboratory in Edmonton, Alberta, Canada."
Regulatory
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ClarityDX Prostate®
over1year
Nanostics Receives CE Mark for its ClarityDX Prostate Test to Detect Clinically Significant Prostate Cancer (Canada Newswire)
"Nanostics Inc...is excited to announce today that it has received the CE-IVD Mark for its ClarityDX Prostate® test. This regulatory milestone allows Nanostics to market and sell ClarityDX Prostate® in Europe, as well as other countries that require the CE Mark for market access."
European regulatory
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ClarityDX Prostate®