Research & Development
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
Biofidelity developing assay for single-molecule detection of multiple gene fusions
The firm said its assay analyzes DNA and RNA concurrently from a single patient sample and can return results within two days.
October 18, 2022
Daxor highlights study on test in heart failure management
Daxor highlighted results of a study from Duke Heart validating the utility of the firm's diagnostic blood test in optimizing the therapeutic management of heart failure patients.
October 3, 2022
Reading blood-oxygen saturation levels on a smartphone
In the study, University of Washington and University of California San Diego researchers demonstrated that the use of a smartphone camera and flash could enable detection of blood oxygen saturation levels comparable to those measured in a clinic using a pulse oximeter clipped to a finger.
September 20, 2022
Ibex announces study results for breast pathology platform
Ibex chief medical officer Dr. Judith Sandbank reported at the congress 100% sensitivity and specificity for pathologists diagnosing breast cancer using the platform.
September 8, 2022
Week in Review: At-home flu testing, asymptomatic monkeypox, telediagnostic accuracy, and more
Dear LabPulse.com member,
September 7, 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
Week in Review: Elizabeth Holmes sentenced; good cholesterol worse for some adults; earlier type 2 diabetes diagnosis; and more
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Freenome launches study of multiomics cancer platform
The Sanderson Study will generate evidence of clinical validation for certain high- and elevated-risk populations while refining the platform's cancer classification and risk prediction models, the South San Francisco-based firm said.
September 5, 2022
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
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