Research & Development
Validation: Page 3
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
Immunovia touts performance of PanCan-d test in clinical study
The test detected pancreatic ductal adenocarcinoma with 99% specificity and 89% sensitivity in stage I/II when excluding individuals with low levels of CA 19-9, an antigen released by pancreatic cancer cells.
February 17, 2022
Datar secures FDA breakthrough nod for prostate cancer test
TriNetra-Prostate identifies early-stage prostate cancer in men between the ages of 55 and 69 with more than 99% accuracy, the company said. It requires 5 ml of blood and is indicated for men with a serum prostate-specific antigen (PSA) measure of 3 ng/mL or higher, according to Datar.
February 13, 2022
AI of pathology slides improves prostate cancer diagnosis
The study suggests that AI has the potential to transform histopathological evaluation and optimize the risk stratification and clinical management of prostate cancer, giving it more of a precision approach, according to the study's authors, from the University of Wisconsin and elsewhere.
November 3, 2021
MiR Scientific touts data on prostate cancer liquid biopsy
MiR Sentinel was able to make the determination from a single urine sample, according to the company. Also, these new data validate a study that was published in September 2020 in the Journal of Urology, the company noted.
September 19, 2021
FDA clears Thermo Fisher's new blood test for lupus
The EliA SmDP-S Test is designed to reduce the number of false-positive results and provide improved diagnostic guidance for SLE. The new test enhances specificity without sacrificing sensitivity, Thermo Fisher said.
August 25, 2021
Scientists develop spectroscopy-based COVID-19 triage tool
Indian and Australian researchers collected infrared spectra of blood plasma from 160 COVID-positive patients from Mumbai (130 as a training set for model development and 30 as a blind test set for model validation). They established a simple plasma processing and ATR-FTIR data acquisition procedure using 75% ethanol for viral inactivation.
August 18, 2021
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