Top 10 Lab Stories for 2024 Reflect Important Trends

By Robert Michel | From the Volume XXXI, No. 17 – December 16, 2024 Issue

CEO SUMMARY: Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the…

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November 25, 2024, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue

Disruption is happening in the consumer genetic testing marketplace. In recent weeks, news outlets in the United Kingdom reported that Atlas Biomed, a consumer genetic testing company founded in 2016, had simply “disappeared.” Malwarebytes said Atlas Biomed’s “London offices …

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November 4, 2024, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXXI No. 15 – November 4, 2024 Issue

Artificial intelligence (AI) is coming to the federal Food and Drug Administration (FDA) and the Veterans Administration (VA). Last week, on Oct. 30, the two agencies issued an announcement that they would partner “to launch an interagency testing ground forchealth…

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Invitae’s Troubled Journey: Rise, Fall, and Bankruptcy

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

ON MAY 7, THE REMNANTS OF GENETIC TESTING GIANT INVITAE (NYSE: NVTA) were scooped up by …

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Labs Should Prepare for Arrival of ‘Perfect Storm’

By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue

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…

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Invitae Cuts Costs to Rebuild Oncology Testing Pipeline

By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue

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…

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December 26, 2023, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue

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…

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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…

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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…

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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…

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