TAG:
Invitae
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…
September 11, 2023, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXX, No. 13 – September 11, 2023 Issue
Here’s another twist in the saga of Theranos, the defunct and discredited lab testing company. Consumers who received inaccurate results from Theranos’ blood tests may get some measure of justice. Walgreens Boot…
Elizabeth Holmes’ Appeal Questions Competence of CLIA Lab Director
By Scott Wallask | From the Volume XXX No. 4 – March 6, 2023 Issue
TANTALIZING DETAILS ABOUT FORMER THERANOS CEO ELIZABETH HOLMES’ purchase of a one-way plane ticket to Mexico prior to her conviction grabbed headlines following the filing of a motion to appeal her conviction. However, for clinical labo…
August 29, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 12 – August 29, 2022 Issue
Interesting things may be unfolding in the genetic testing marketplace. In the past few weeks, at least two high-profile genetic testing companies announced major layoffs. First was Invitae, a genetics testing company in San Francisco. At the end of July, it announced plans to eliminate 1,000 …
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 …
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…
July 6, 2021 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVIII, No. 9 – July 6, 2021 Issue
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 XXX, Number 17 – December 4, 2023
In this issue, The Dark Report discusses the impact of artificial intelligence-powered solutions. The Dark Report suggests that it is timely for lab managers at all levels of the organization to begin learning about the field of artificial intelligence. In addition to this topic, discover how labs should be prepared for data to dominate diagnostics, understand that CLIA lab directors must monitor delegated duties, and stay informed about the latest regulatory and IVD updates.
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