Erik L. Ridley

Moderate Complexity Test
AACC lobbies against greater regulation of lab-developed tests
The 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, 2022
2020 07 01 22 14 2802 Washington Dc Capitol 400
Alzheimer's
Quest publishes Alzheimer’s report, unveils blood test
The 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, 2022
2019 07 15 19 08 6013 Amyloid Plaque Alzheimer 400
Pancreatic Cancer
AI spots patients at elevated risk for pancreatic cancer
A 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, 2022
2020 03 12 20 41 0454 Computer Brain Circuit Ai 400
Infectious
Blue Cross sues GS Labs over COVID test payments
Filed 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, 2022
2020 07 22 15 50 6516 Lawsuit 400
Health Topics
AI mines CT, lab results to predict COVID-19 severity
A 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, 2022
2020 10 09 22 54 5002 Covid 19 Data Ai Information 400
Collaboration
BD buys flow cytometry technology firm Cytognos
In 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, 2022
2019 08 20 21 56 4986 Becton Aacc 2019 400
510(k)
FDA clears 1st prostate pathology AI software application
Designed 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, 2021
2019 02 13 19 24 5396 Fda Logo V2 400
Validation
AI can lend a hand in diagnosis, prognosis of oral SCC
After 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, 2021
2021 08 18 23 12 2135 Computer Ai Artificial Illustration 400
Health Topics
FDA warns of false positives from SARS-CoV-2 antigen tests
These 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, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
Clinical Trial
3D-printed swabs make the grade for COVID-19 testing
A 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, 2020
2020 06 02 22 19 7693 Coronavirus Swab Ppe 400
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Mergers & Acquisitions
$16.5B CDMO deal unhindered by role in broader pharma supply chain
Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.
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Compliance and Regulation
Texas lab owner accused of $79M RPP fraud scheme
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FDA Warning Letter
FDA sounds bacteria alarms over CGMP violations in Maine
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Research and Development
Revvity broadens work in newborn testing for NHS England
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$16.5B CDMO deal unhindered by role in broader pharma supply chain
By Liz Carey
Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.
December 11, 2024
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Texas lab owner accused of $79M RPP fraud scheme
By LabPulse.com staff writers
The DOJ implicated a Texas clinical laboratory owner and operator in respiratory pathogen panel testing fraud scheme.
November 25, 2024
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FDA sounds bacteria alarms over CGMP violations in Maine
By Liz Carey
Tom's troubles highlight the importance of being inspection-ready.
November 21, 2024
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Revvity broadens work in newborn testing for NHS England
By LabPulse.com staff writers
Revvity, formerly PerkinElmer, will expand its work with Genomics England to continue the Generation Project.
November 20, 2024
Baby Infant Mom Closeup Social
Roche gets CE Mark for ovarian cancer CDx test
By LabPulse.com staff writers
Roche has received the CE Mark under the European Union's In Vitro Diagnostic Regulation for its companion diagnostic (CDx) test, which is designed to aid in identifying ovarian cancer patients eligible for targeted treatment with Abbvie's Elahere.
November 19, 2024
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AMP reviews pitfalls of NGS testing for SARS-CoV-2
By Liz Carey
Document offers key pre-analytical, analytical, and post-analytical considerations to help improve NGS-based surveillance programs.
November 15, 2024
Covid Treatment Doctor Social
FDA fall IVD roundtable avoids LDT questions
By Liz Carey
In addition, CAP LDT webinar offers beginning guide for phase one compliance.
November 12, 2024
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Lucy Letby murder case flags immunoassays as unreliable for medical evidence
By Liz Carey
At least one pathologist has said it was wrong for scientists representing Liverpool Clinical Laboratories to insist insulin poisoning was the only explanation in a series of high-profile newborn deaths in the U.K., The Telegraph reported.
October 28, 2024
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Digital pathology rollouts race for proof-of-concept at national level
By Liz Carey
U.K. invests in clinical trial security while Australia's health minister issues powerful ultimatum.
October 29, 2024
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Caris Life Sciences embarks on 10K-sample breast cancer biomarker analysis project
By LabPulse.com staff writers
Caris will perform comprehensive molecular characterization of TAILORx tissue samples.
October 25, 2024
Dna Sequence (1)
ASCLS seeks support for med lab personnel act
By LabPulse.com staff writers
The proposed legislation includes loan repayment provisions and requires $25 million in the first year.
October 25, 2024
Washington Dc Capitol
Pathology groups' antitrust legal fight heats up
By LabPulse.com staff writers
A lawsuit in which Iowa pathologists are suing their former colleagues is escalating, with one side accusing the other of attempting to maintain a monopoly at the expense of patients.
October 24, 2024
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