TEST:

ClarityDX Prostate®

P=N/A, N=1074, Not yet recruiting, 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."

These optimized risk models provide high accuracy for predicting csPCa in various clinical settings. Including MRI data greatly increases model accuracy, while DRE has a smaller effect on model accuracy.

"Nanostics Inc...announced today that it received an investment from the University of Alberta Innovation Fund (UAIF) to help propel adoption of Nanostics' ClarityDX Prostate test in North America....Funds raised through the UAIF will go towards expanding access to ClarityDX Prostate across North America and supporting the expansion of its product pipeline, including the development of ClarityDX Bladder, a minimally invasive bladder cancer diagnostic test."

P=N/A; Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Mar 2024

"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."

"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."

"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."