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Clinical Utility
Clinical investigators need to be wary of confounding and bias in real-world studies; here is what to look for and how to address it
Clinical investigators need to look out for confounding and bias associated with real-world data in randomized trials and observational studies used to produce real-world evidence (RWE) to assess the safety and efficacy of an intervention.
March 17, 2023
After Illumina presentation highlighting Grail potential comes a possible EU fine
At the J.P. Morgan healthcare event this week, Illumina's CEO said Grail must be operated separately and independently pursuant to measures required by the EU.
January 12, 2023
Biological Dynamics embarks on clinical utility studies for pancreatic cancer detection assay
Biological Dynamics said that it is collaborating with Qure Healthcare and Curta to also evaluate the effects of its pancreatic cancer detection assay on patient outcomes and healthcare economics.
November 23, 2022
Roche points to results of heart failure study leveraging its cardiac hormone biomarker and test
The results were shared this week at an American Heart Association Late-Breaking Scientific Session and published simultaneously in the Lancet.
November 9, 2022
Self-supervised deep learning algorithm shows promise for rapid whole-slide-imaging retrieval
Brigham and Women’s Hospital researchers are developing an algorithm to speed whole-slide-imaging retrieval from large digital repositories.
October 19, 2022
Prelude Dx to present clinical utility data for DCIS risk assessment test
DCISionRT predicts radiation therapy benefit through a risk assessment test for patients with ductal carcinoma in situ (DCIS).
October 21, 2022
Interpace Biosciences announces data for test to assess indeterminate thyroid nodules
The data support both versions of its test platform and a blinded analysis of pairwise miRNA expression profiling demonstrated greater accuracy than its original testing platform, the firm said.
October 21, 2022
Natera presents colorectal, breast cancer data at ESMO 2022
One abstract, related to the Bellini trial, examined the potential clinical utility of circulating tumor DNA (ctDNA) in assessing the response to neoadjuvant immunotherapy in patients with early-stage (I-II) triple-negative breast cancer (TNBC).
September 12, 2022
Thermo Fisher launches NGS test, software for clinical labs
Using targeted NGS technology, the Oncomine Dx Express Test delivers clinically relevant tumor mutation profiling in 24 hours to aid healthcare professionals in therapy management of cancer patients in accordance with professional guidelines, Thermo Fisher said.
August 29, 2022
OncoCyte announces evaluation of gene expression test
In a clinical trial, 429 patients diagnosed with metastatic urothelial cancer were treated with atezolizumab (Tecentriq, Genentech), an immune checkpoint inhibitor.
August 24, 2022
Natera files presubmission with FDA for NIPT test
According to the FDA, Q-Subs can serve as helpful tools in the premarket submission process.
August 10, 2022
Renalytix underscores KidneyIntelX clinical results
Specifically, the results show that these physicians understand the value of the test in determining treatment decisions for adults with type 2 diabetes and early chronic kidney disease stages 1 to 3, also known as diabetic kidney disease, the firm said.
August 7, 2022
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