Late Breaking Lab News
November 25, 2024, Intelligence: Late-Breaking Lab News
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 …
November 4, 2024, Intelligence: Late-Breaking Lab News
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…
October 14, 2024, Intelligence: Late-Breaking Lab News
Babson Diagnostics of Austin, Texas, received a “strategic investment” from Becton, Dickinson and Company (BD). The amount of the investment was not disclosed. In the past year, Babson launched an innovative lab testing service with retail pharmacies in Austin an…
September 23, 2024, Intelligence: Late-Breaking Lab News
One sign of the financial turmoil associated with the market for genetic tests is the news that all seven independent directors of 23andMe’s board resigned at the same time on Sept. 18. The reason given was that these directors opposed the plan of CEO and co-founder Anne Wojcicki t…
September 3, 2024, Intelligence: Late-Breaking Lab News
To challenge the federal Food and Drug Administration (FDA) final rule on laboratory developed tests (LDTs,) the Association for Molecular Pathology (AMP) filed a lawsuit on August 20, 2024, in the United States District Court for the Southern District of Tex…
August 12, 2024, Intelligence: Late-Breaking Lab News
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…
July 22, 2024, Intelligence: Late-Breaking Lab News
Some hospitals failing to comply with the federal price transparency regulation have been fined. The website of CMS.gov lists 15 hospitals and the amount each was fined. On June 6, 2022, the first fines were levied against Northside Hospital of Atlanta ($883,130) and Northsid…
July 1, 2024, Intelligence: Late-Breaking Lab News
Last week, it was announced that Quest Diagnostics “would acquire select laboratory assets from 12-hospital Allina Health” the Minneapolis-based health system. Quest stated, “Under the terms of the definitive agreemen…
June 10, 2024, Intelligence: Late-Breaking Lab News
Once a high-flier lab test manufacturer with a market valuation of $2 billion, Cue Health of San Diego filed for Chapter 7 bankruptcy on May 28. Analysts now say the company is valued at about $15 million. Founded in 2010, Cue Health was developing a test system that consumers could …
May 20, 2024, Intelligence: Late-Breaking Lab News
Last month, members of a class action lawsuit against Theranos and other defendants received settlement checks. Members of the class included TDR’s Editor-in-Chief, Robert Michel, and his wife, Deborah. On behalf of The Dark Report, the Michels had investigated the actual laborator…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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