Research & Development
Validation: Page 2
Medial EarlySign, Roche partner on lung cancer detection
The goal is to deliver validated clinical machine learning models for lung cancer detection with EarlySign's LungFlag technology. The technology uses a variety of signals, including basic demographic, medical, drug, and routine clinical lab data.
July 7, 2022
Mainz Biomed launches biomarker study for ColoAlert
Acquired by Mainz from the Université de Sherbrooke in Quebec in January, the mRNA biomarkers had been shown in prior studies to provide high sensitivity and specificity for detecting colon cancer and precancerous lesions.
June 27, 2022
Oxford BioDynamics launching oncology test in the U.K.
The company noted that its EpiSwitch CiRT blood test predicts the likelihood of a cancer patient's response to ICI therapeutics that include anti-PD-L1 and anti-PD-1 immunotherapies.
June 20, 2022
Veracyte announces evidence supporting thyroid genomic test
When the test deems a nodule suspicious, the patient's risk of malignancy is consistent and higher than that reported in the classifier's original clinical validation study, the firm said.
June 19, 2022
Flagship Biosciences announces study validating assay
The Broomfield, CO-based company said its digital PD-L1 assay provides solutions to current challenges with the use of immunohistochemistry (IHC) to determine the level of PD-L1 expression in tumor tissues.
June 13, 2022
Applied DNA Sciences, EvviVax announce cancer vaccine data
The firms noted that the study, published on June 6, found that two LinearDNA therapeutic cancer vaccines elicited a strong immune and specific antitumor response in mouse models using electro-gene-transfer as the delivery method.
June 6, 2022
DNA forensic evidence frees Ohio man of rape, attempted rape
‘Good’ cholesterol worse for some adults: NIH study
Empatica receives FDA clearance for digital biomarker platform, closes Series B financing
AnchorDx enrolling U.S. clinical trial for bladder cancer assay
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Week in Review: Elizabeth Holmes sentenced; good cholesterol worse for some adults; earlier type 2 diabetes diagnosis; and more
Bristol Myers Squibb promotes ctDNA liquid biopsy study
BMS scientists demonstrated that Predicine's PredicineAtlas liquid biopsy next-generation sequencing (NGS) assay outperformed four other tests in detection sensitivity, specificity, accuracy, and reproducibility. The Precidine assay also proved capable of identifying gene deletion or copy number reductions in the study, Bristol Myers Squibb said.
May 17, 2022
Delfi enrolls first participants in liquid biopsy lung cancer trial
The CASCADE-LUNG study is expected to enroll 15,000 patients and aims to clinically validate Delfi's test, which detects a blood-based signal of undiagnosed lung cancer. It is a prospective, multicenter trial that will enroll participants at the time of their low-dose computed tomography (LDCT) lung cancer scans.
May 8, 2022
Guardant releases colorectal cancer blood test
In a validation effort using 309 patient samples (including 92 with colorectal cancer), the Shield test showed a sensitivity of 91% and a specificity of 92% for detecting colorectal cancer. It is intended for adults 45 years and older who are not current with screening recommendations, are asymptomatic, and are at average risk for the disease.
May 1, 2022
Immunovia applies to AMA for PLA code
The company has touted the results of a study showing that the test detected stage I/II pancreatic ductal adenocarcinoma with 99% specificity and 89% sensitivity.
April 17, 2022
Fosun's COVID-19 test approved in China
The test has high sensitivity and specificity, a strong anti-interference ability, and no cross-reactivity among viruses and bacteria, Fosun said.
April 14, 2022
Sysmex, Eisai tout Alzheimer's research at AD/PD 2022
As part of a nonexclusive agreement to create diagnostic agents for dementia, researchers from the companies compared the performance of the plasma beta-amyloid ratio measured using the Sysmex HISCL automated immunoassay system with that of amyloid status on positron emission tomography (PET) imaging as determined by the Centiloid method. Their technique was assessed in a discovery study in 180 patients and in a validation study involving 191 patients who were clinically diagnosed with mild Alzheimer's disease or mild cognitive impairment.
March 22, 2022
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