TAG:
GeneDx
February 17, 2025, Intelligence: Late-Breaking Lab News
To implement a corporate restructuring, Becton Dickinson (BD) announced on Feb. 5, 2025, that it would proceed to “separate BD’s Biosciences and Diagnostic Solutions business from the rest of BD.” The company plans to complete this action by the end of 2025. Clinical laboratori…
State of Whole Genome Sequencing of Newborns
CEO SUMMARY: Genetic medicine continues to support advances in precision medicine (or personalized medicine, if you prefer). This is true in pediatrics, where several statewide pilot programs—each involving tens of thousands of newborns—are publishing studies that demonstrate how exom…
November 13, 2023, Intelligence: Late-Breaking Lab News
Federal regulators recently confirmed that Dec. 4 remains the deadline for public comment on the proposed rule that the federal Food and Drug Administration (FDA) would use to regulate laboratory developed tests (LDTs). This was confirmed during a public webinar for the lab and in vi…
Whole Genome Sequencing for Newborns Gains Favor
CEO SUMMARY: Evidence is swiftly accumulating that use of rapid Whole Genome Sequencing (rWGS) for certain children in NICUs can enable diagnostic insights that guide effective interventions. Further, these pilot rWGS programs in childrens’ hospitals are showing a solid return on invest…
October 23, 2023, Intelligence: Late-Breaking Lab News
Earlier this summer, a 16-year-old completed his bachelor of science degree, along with his certification as a Medical Laboratory Scientist (MLS). The faculty at LSU Health-Shreveport reported that Isak Schmidley, MLS (ASCP)BC is the youngest graduate of its Medical Laboratory Scienc…
India’s Neuberg Diagnostics Expands into U.S. Market
“Our idea is to enhance the access and affordability for next-generation techniques, meaning molecular diagnostics, genomics, pathology, digital pathology, proteomics, metabolomics, and all that. This is the spirit behind Neuberg Diagnostics. —GSK Velu, PhD, BPharm …
Benefits Investigation Is Growing Issue for Genetic Testing Labs
QUIETLY AND WITH LITTLE NEWS COVERAGE, a new complication is challenging clinical laboratories that offer genetic testing. It involves a steady growth in the number of patients who do a “benefits investigation” before allowing their physician to order a genetic test….
July 6, 2021 Intelligence: Late-Breaking Lab News
Did the SARS-CoV-2 virus infect people in the United States earlier than the first case diagnosed on Jan. 19, 2020? A newly-published study in Clinical Infectious Diseases, says there is evidence of COVID-19 infections in December 2019. The research team included scientists from the Nationa…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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