TAG:
GeneDx
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 XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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