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Validation: Page 2
Interpace announces validation data for thyroid cancer test
The company said the most recent data shows that the addition of microRNA pairwise expression profiling on its ThyraMIRv2 assay provides clinically and statistically superior risk stratification of indeterminate thyroid nodules by the original ThyraMIR assay.
September 1, 2022
Researchers develop same-day fetal chromosome test
In the New England Journal of Medicine on Thursday, the investigators described a rapid nanopore sequencing-based screen for aneuploidy in reproductive care, saying they have developed and validated a new short-read-based approach for library preparation, sequencing, and data analysis.
August 17, 2022
Viome launches early detection test for oral and throat cancers
The test leverages mRNA technology and an artificial intelligence platform to detect biomarkers for oral and throat cancer with 95% specificity and 90% sensitivity rates, the firm said.
August 3, 2022
North American Diagnostics recalls COVID-19 rapid tests
"North American Diagnostics did not provide the FDA with adequate validation data to show that the test's performance is accurate," the FDA wrote in the recall announcement. "This means there is a risk of potential false negative, false positive, or misinterpretation of results."
July 31, 2022
Veracyte genomic test classifies lung cancer risk in study
In a study published in the journal PLOS One, a group of researchers has clinically confirmed that Veracyte's Percepta Genomic Sequencing Classifier (GSC) can accurately classify lung cancer risk from inconclusive samples taken in a bronchoscopy.
July 19, 2022
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
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
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