TEST:

ClarityDX Prostate®

" Nanostics Inc...developing diagnostic tests with its ClarityDX® platform technology, announced today significant financial support from Genome Canada and Genome Alberta through the Canadian Biotechnology Innovation and Commercialization Initiative (CBIC) to accelerate the integration of ClarityDX Prostate into the standard of care for prostate cancer screening across Canada. This project is propelled by academic, clinical, and economic collaborations with leadership from Dr. John Lewis, Bird Dogs Chair in Translational Oncology at the University of Alberta, Partnerships and Innovation at Acute Care Alberta (formerly Alberta Health Services), and Nanostics."

P=N/A, N=2800, Active, not recruiting, Nanostics | Trial completion date: Dec 2024 --> Mar 2027 | Trial primary completion date: Mar 2024 --> Nov 2026

"Nanostics Inc...with its ClarityDX® platform technology, has met a major milestone with the recruitment of the first patient into its recently launched clinical utility study (NCT06678828). The study will quantify the clinical and economic impact of incorporating ClarityDX Prostate into the standard of care for prostate cancer screening."

P=N/A, N=1074, Recruiting, Nanostics | Not yet recruiting --> Recruiting | Initiation date: Dec 2024 --> Apr 2025 | Trial primary completion date: Oct 2027 --> Apr 2027

P=N/A; N=1074; Not yet recruiting; Sponsor:Nanostics

"Nanostics was excited to be the first to be featured on a new podcast by AIMSS, called ByteMed! Watch us delve into the transformative world of diagnostic technology. Discover how the innovative platform, ClarityDX®, harnesses advanced machine learning algorithms to create noninvasive disease risk scores, particularly in the realm of cancer detection."

"Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX platform technology, and OncoHelix, a leader in precision diagnostics, today announced their partnership to provide ClarityDX Prostate to healthcare providers and men in the Middle East...ClarityDX Prostate uses biological data, clinical information, and AI-powered learning models to generate a risk score for aggressive prostate cancer, marking a significant advancement in prostate cancer screening....OncoHelix provides advanced molecular diagnostics and immune profile testing to the Middle East and North Africa (MENA) region through OncoHelix-coLAB, a state-of-the-art laboratory within Burjeel Medical City, Abu Dhabi."

"Nanostics...and Protean BioDiagnostics...announced their partnership to provide CDX Prostate in the United States....CDX Prostate uses biological data, clinical information, and AI-powered learning models to generate a risk score for aggressive prostate cancer, marking a significant advancement in prostate cancer screening. It provides critical support to men and their healthcare providers in making more informed decisions about whether to proceed with a biopsy following a high prostate-specific antigen (PSA) test result or an abnormal Digital Rectal Exam (DRE)."

"Nanostics Inc...is thrilled to announce the publication of the research supporting the development of the ClarityDX Prostate test. This test combines an optimized machine learning platform with blood-based biomarkers for clinically significant prostate cancer and clinical biomarker data to generate the patient's risk score for clinically significant (defined as Grade Group 2 and above) prostate cancer."

ClarityDX Prostate showed higher accuracy for predicting the risk of csPCa than PSA alone and the tested model-based risk calculators. Using this test as a reflex test in men with elevated PSA levels may help patients and their healthcare providers decide if a prostate biopsy is necessary.

"Nanostics Inc...is thrilled to announce today that men can now provide blood samples for its ClarityDX Prostate test at LifeLabs collection sites across British Columbia, Saskatchewan, and Ontario....ClarityDX Prostate is available in British Columbia, Saskatchewan, and Ontario as a laboratory-developed test from Nanostics Clinical Laboratory in Edmonton, Alberta. In these provinces, tests are ordered, analyzed, and reported to the prescribing healthcare provider by Nanostics."

"Nanostics Inc...signed an agreement with Quebec-based CDL Laboratories (CDL) to expand access to the ClarityDX Prostate to men and their healthcare providers."