Research & Development
Clinical Utility: Page 2
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
ASCO presentation highlights clinical utility of ctDNA testing
Findings from the study were presented Saturday at the annual meeting of the American Society of Clinical Oncology and published in the New England Journal of Medicine.
June 5, 2022
Veracyte touts gene expression study data at ESMO meeting
To generate consensus regarding the clinical utility in breast cancer treatment of GEP tests, including Veracyte's Prosigna breast cancer assay, 133 specialists from 11 European countries were surveyed in the PROCURE study.
May 3, 2022
Illumina brings whole-genome sequencing to German hospital
Under the project, the diagnostic efficacy of rWGS will be evaluated in the institution's neonatal and pediatric intensive care units, according to the company. At least 100 critically ill children with suspected genetic disorders will be tested, as well as their parents when possible.
April 26, 2022
Natera touts study evaluating Prospera test
Researchers assessed the clinical utility of Prospera in an analysis of biopsy data contemporaneous to dd-cfDNA results in 879 patients at 33 participating clinics. They found 18 of 28 patients with biopsy-matched high-risk dd-cfDNA test results were confirmed to have active rejection, demonstrating a reported 64% positive predictive value, according to a study published in the December issue of Transplantation Proceedings.
February 17, 2022
MD Anderson, BostonGene enter into strategic alliance
The agreement expands upon existing research collaborations between BostonGene and multiple center researchers. MD Anderson and BostonGene will work together on clinical utility studies designed to support incorporating BostonGene testing into national guidelines and adoption as a national standard of care.
September 30, 2021
Thermo Fisher, Daiichi Sankyo to develop NSCLC test
Their collaboration will focus on identifying HER2 gene mutations using Thermo Fisher's next-generation sequencing-based Oncomine Dx Target test. The companion test will be used to identify patients eligible for treatment with trastuzumab deruxtecan (Enhertu), a HER2 directed antibody drug conjugate developed by Daiichi Sankyo and Astra Zeneca that is currently in global phase II development for HER2-mutated or HER2-overexpressing NSCLC.
June 23, 2020
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