TAG:
Illumina
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…
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…
November 21, 2022, Intelligence: Late-Breaking Lab News
In yet another employment ripple from the pandemic, a group of more than 75 pathologists penned a letter to Congress urging lawmakers to retain the option for remote diagnostic work. In the letter, which appeared in the Oct. 20 issue of Nature, the pathologists wrote, āDuring the COVID-19 pa…
Ravgen Gets $272.5 Million Verdict against Labcorp
CEO SUMMARY: In September, a jury returned a $272.5 million verdict against Labcorp, representing royalties owed to biotech company Ravgen for infringement of its diagnostic genetic test patent. Soon after, Quest Diagnostics settled a similar lawsuit with Ravgen before its tri…
January 31, 2022 Intelligence: Late-Breaking Lab News
DNA-based breast cancer testing is taking a step forward.Ā Illumina in San Diego, which sells next-generation sequencing (NGS) technology, announced a partnership with Agendia in Irvine, Calif., to develop in vitro diagnostic tests for oncology. Agendia offers proprietary breast …
Indiaās Neuberg Diagnostics Expands into U.S. Market
āOur 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. āGSK Velu, PhD, BPharm …
August 16, 2021 Intelligence: Late-Breaking Lab News
Elizabeth Holmes, the disgraced ex-CEO of the now-defunct Theranos, continues to be in the news. In the past several weeks, news reports indicate that she gave birth to a child, but whether it is a boy or a girl has not been reported. Also in recent weeks, attorneys have been in court arguing …
Genetic Tests Grow in Number, Complexity
CEO SUMMARY: Getting paid for genetic tests continues to be a challenge. This is true for both payers and the labs that perform the tests. Even physicians are dissatisfied with the status quo because they must deal with patients unhappy about the high cost of genetic tests. The prob…
PacBio Beefs Up with Purchase of Omniome for $800 Million
FORWARD-LOOKING PATHOLOGISTS AND LAB ADMINISTRATORS understand that the next big game in medical laboratory testing will be assays built upon genome sequencing. They also know that several companies are racing to produce gene sequencing instruments that are faster, simpler, and less costly in order t…
Two Collaborations: LabCorp-Thermo Fisher, Roche-Illumina
InĀ dealsĀ relatedĀ to Ā the Ā pursuit of companion diagnostics, two lab companies announced collaboration deals with companies that manufacture gene-sequencing equipment. The deals were announced on consecutive days earlier this month. Financial terms were not disclosed. On Jan. 13, Ro…
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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