Validation: Page 2

Biofidelity developing assay for single-molecule detection of multiple gene fusions

By LabPulse.com staff writers

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

By LabPulse.com staff writers

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

By Jared Berberabe

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

By LabPulse.com staff writers

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

By Leo O'Connor

Dear LabPulse.com member,

September 7, 2022

Freenome launches study of multiomics cancer platform

By LabPulse.com staff writers

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

By LabPulse.com staff writers

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

By Leo O'Connor

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

By LabPulse.com staff writers

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

By LabPulse.com staff writers

"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

By Dexter Johnson

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

By LabPulse.com staff writers

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

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