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August 12, 2024, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXI, No. 11 – August 12, 2024 Issue
In recent years, many of the national retail pharmacy chain operators announced big plans to open primary care clinics. Now, after substantial investments of billions of dollars, those same retail pharmacy chains are unwinding these business lines. This spring, Walmart announced it w…
November 13, 2023, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXX, Number 16 – November 13, 2023 Issue
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
By Robert Michel | From the Volume XXX, Number 15 – October 23, 2023 Issue
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
By Robert Michel | From the Volume XXIX, No. 16 – November 21, 2022 Issue
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, “During the COVID-19 pa…
Ravgen Gets $272.5 Million Verdict against Labcorp
By Scott Wallask | From the Volume XXIX, No. 15 – October 31, 2022 Issue
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
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
DNA-based breast cancer testing is taking a step forward. 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 …
India’s Neuberg Diagnostics Expands into U.S. Market
By Robert Michel | From the Volume XXVIII, No. 11 – August 16, 2021 Issue
“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 …
August 16, 2021 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVIII, No. 11 – August 16, 2021 Issue
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
By Robert Michel | From the Volume XXVIII, No. 10 – July 26, 2021 Issue
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
By Robert Michel | From the Volume XXVIII, No. 10 – July 26, 2021 Issue
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…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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