July 2024

What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule

Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This compliance will require substantial staff time and costs that may outweigh the benefit to the lab […]

To access this post, you must purchase The Dark Report.

What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule Read More »

What’s a Big Headwind for Labs? It’s the LDT Rule!

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

EXECUTIVES AT PUBLICLY-TRADED CORPORATIONS AND THE FINANCIAL ANALYSTS WHO COVER THESE COMPANIES like to use the term “headwinds” when describing problems preventing these companies from succeeding. It’s the polite euphemism that acknowledges real-world negatives without calling them by their real names, such as high customer turnover, shrinking market share, and poor economic times. I

To access this post, you must purchase The Dark Report.

What’s a Big Headwind for Labs? It’s the LDT Rule! Read More »

Global Computer Outage Shows Risk to Clinical Labs

Clinical Laboratory / Robert Michel

CEO SUMMARY: Last Friday’s global computer outage was due to a faulty update to a widely used endpoint security software system. The level of disruption worldwide in air travel, commerce, and information processing was unprecedented. This incident highlights that there are risks when a clinical laboratory or hospital puts both data and services in the

To access this post, you must purchase The Dark Report.

Global Computer Outage Shows Risk to Clinical Labs Read More »

Language in Draft House Bill Directs FDA to Suspend LDT Rule

Laboratory Compliance / Robert Michel

THERE IS AN INTERESTING NEW DEVELOPMENT associated with the regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA). In recent days, a House committee published draft legislation that directs the FDA to suspend its implementation of the LDT rule. As part of an appropriations bill, the House Appropriations Committee issued a

To access this post, you must purchase The Dark Report.

Language in Draft House Bill Directs FDA to Suspend LDT Rule Read More »

2023 Ranking of the World’s Top 13 IVD Corporations

In Vitro Diagnostics / Robert Michel

BASED ON 2023 DIAGNOSTICS-RELATED REVENUE, four in vitro diagnostics (IVD) manufacturers continued to lead the global IVD market just as they did in 2022. They are: Thermo Fisher Scientific, Inc., Roche Holdings, Abbott Laboratories, and Danaher Corporation. The top 13 firms collected $88.7 billion in annual revenue, compared to $99 billion in fiscal 2022 and

To access this post, you must purchase The Dark Report.

2023 Ranking of the World’s Top 13 IVD Corporations Read More »

Labs, Payers Don’t Like Prior Authorization for Genetic Tests

Managed Care Contracts / Robert Michel

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. Prior authorization requirements for genetic

To access this post, you must purchase The Dark Report.

Labs, Payers Don’t Like Prior Authorization for Genetic Tests Read More »

What Labs with LDTs Must Do to Comply with FDA’s LDT Rule

Laboratory Compliance / Robert Michel

CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This compliance will require substantial staff time and costs that may outweigh the benefit to

To access this post, you must purchase The Dark Report.

What Labs with LDTs Must Do to Comply with FDA’s LDT Rule Read More »

Quest Diagnostics Moves to Acquire LifeLabs of Canada

Laboratory Management / Robert Michel

QUEST DIAGNOSTICS, ALREADY A CLINICAL LABORATORY BEHEMOTH IN THE U.S., is expanding its North American footprint by acquiring Canada’s largest independent laboratory company. Quest Diagnostics announced on July 3 that it had a “definitive agreement” to acquire LifeLabs from the Ontario Municipal Employees Retirement System (OMERS) in a deal valued at approximately $1.35 billion in

To access this post, you must purchase The Dark Report.

Quest Diagnostics Moves to Acquire LifeLabs of Canada Read More »

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

Genetic Testing / Robert Michel

ON MAY 7, THE REMNANTS OF GENETIC TESTING GIANT INVITAE (NYSE: NVTA) were scooped up by Labcorp when the United States Bankruptcy Court approved Labcorp’s bid to acquire Invitae’s assets. Labcorp will receive “select assets of Invitae on a going concern basis for $239 million in cash consideration, plus other non-cash consideration,” PR Newswire noted.

To access this post, you must purchase The Dark Report.

Invitae’s Troubled Journey: Rise, Fall, and Bankruptcy Read More »

July 22, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

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 Northside Hospital Cherokee of Canton, Ga. ($214,320). On Feb. 27, 2023, UF

To access this post, you must purchase The Dark Report.

July 22, 2024, Intelligence: Late-Breaking Lab News Read More »