Erik L. Ridley[email protected]Moderate Complexity TestAACC lobbies against greater regulation of lab-developed testsThe Verifying Accurate Leading-edge IVCT Development (VALID) Act would limit the availability of laboratory-developed tests, decreasing patient access to these diagnostic tools, the AACC said. Often created when there is no FDA-approved commercial test available, these tests are frequently used to diagnose rare conditions -- such as genetic abnormalities in children -- or to respond to emerging health threats such as COVID-19, according to the association.May 24, 2022Alzheimer'sQuest publishes Alzheimer’s report, unveils blood testThe report, called "The Coming Alzheimer's Disease Healthcare Revolution: U.S. Physician and Adult Perspectives on the Future of Diagnostics and Treatment," found that 66% of physicians believe that "we are on the precipice of groundbreaking new treatment options" for Alzheimer's disease, according to Quest.May 3, 2022Pancreatic CancerAI spots patients at elevated risk for pancreatic cancerA team of researchers from the U.S. and Denmark used electronic health record (EHR) data from the Danish National Patient Registry to train their algorithm and then tested it on electronic medical records from Mass General Brigham Health Care System in Boston. Their model proved to be highly accurate for predicting patients at high risk for pancreatic cancer on large datasets from both countries.April 8, 2022InfectiousBlue Cross sues GS Labs over COVID test paymentsFiled in the U.S. District Court of Minnesota, the complaint alleges that GS Labs defrauded Blue Cross by submitting tens of thousands of claims using inflated cash prices over the past year.February 28, 2022Health TopicsAI mines CT, lab results to predict COVID-19 severityA team of researchers led by Yibai Xiong and Yan Ma of the China Academy of Chinese Medical Sciences trained three different machine-learning models to identify severe COVID-19 cases at admission based on 23 variables, including chest CT results, one clinical feature, and 21 laboratory values. In testing, the best-performing algorithm yielded an area under the curve (AUC) of 0.970.February 22, 2022CollaborationBD buys flow cytometry technology firm CytognosIn addition to use in MRD applications, the Cytognos technology can also be utilized in immune monitoring research for blood diseases. Terms of the deal were not disclosed.January 31, 2022510(k)FDA clears 1st prostate pathology AI software applicationDesigned to serve as an adjunct to pathologist review of digitized prostate biopsy images, Paige Prostate identifies areas of interest on the images that contain the highest likelihood of cancer. Pathologists can then further review the AI findings if they had not identified these areas of concern on their initial evaluation, according to the FDA.September 20, 2021ValidationAI can lend a hand in diagnosis, prognosis of oral SCCAfter reviewing published studies in the literature on the use of AI with pathology and radiology images in patients with oral SCC, researchers from the University of Hong Kong concluded that the technology yielded good classification accuracy.August 18, 2021Health TopicsFDA warns of false positives from SARS-CoV-2 antigen testsThese false positive findings can occur many reasons, for example when users do not follow instructions for the tests, according to the FDA. The FDA offered several recommendations for clinical laboratory staff and healthcare providers:November 2, 2020Clinical Trial3D-printed swabs make the grade for COVID-19 testingA multidisciplinary research team led by first author Cody Callahan of BIDMC's department of radiology and senior author Dr. Ramy Arnaout, PhD, of the institution's Clinical Microbiology Laboratories investigated over 150 swab designs and nearly 50 materials in a multiphase analysis that included preclinical evaluation, assessment of production considerations, and field testing in a clinical trial.June 11, 2020Page 1 of 2Next PageTop StoriesLawsuitGerman court lifts lower court injunction on sale of NanoString productsIn the latest development of the ongoing litigation between Bruker and 10x Genomics, a court injunction suspending sales of Bruker subsidiary NanoString's CosMx Spatial Molecular Imager products in Germany has been lifted.LawsuitVertex sues HHS for Casgevy fertility program accessDiagnostic TechnologiesFive committee recommendations for clinical laboratory testing and biomarker analysisGuidelineFDA issues alert on BD vial supply shortageSponsor ContentVisit our Molecular Diagnostics Community
