TAG:
Invitae
Labs Should Prepare for Arrival of ‘Perfect Storm’
CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…
Invitae Cuts Costs to Rebuild Oncology Testing Pipeline
INVITAE CORPORATION, A MEDICAL GENETICS COMPANY that had a $1.34 billion loss during the nine months ending Sept. 30, 2023, recently announced coming actions to cut costs and change operations. The San Francisco-based company sold “certain reproductive health assets including ca…
December 26, 2023, Intelligence: Late-Breaking Lab News
Is the world ready for a diagnostic service that performs a whole genome sequence of embryos conceived by in vitro fertilization? That’s the business plan announced on Dec. 5 by San Francisco-based Orchid Health. In covering this development, Science wrote, “Find the emb…
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…
September 11, 2023, Intelligence: Late-Breaking Lab News
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
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
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
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
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. 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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