Issues Archive

The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.

Volume XXIV No. 12 – August 28, 2017

In this issue:

THE ERROR MAY ONLY AFFECT A FEW PATIENTS, but Invitae’s failure to test for the Boland Inversion across some 50,000 patients may set a record for such an error. THE DARK REPORT broke the news of this mistake, and in this issue delivers analysis of the fallout, including the fact that Invitae’s assays are laboratory-developed tests (LDTs), which the FDA has been pushing to regulate for the past three years. Also in this issue, TDR discusses the costs for redoing genetic tests, and Invitae’s push to expand its market share.

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Volume XXIV No. 11 – August 7, 2017

In this issue:

WITH ONLY A FEW MONTHS REMAINING before CMS implements lab fee cuts that will shake the industry to its core, THE DARK REPORT delivers exclusive analysis of the industry’s options to fight back, the reasons why the PAMA rule is flawed, and even how these flaws are believed to have developed when the Protecting Access to Medicare Act was passed in 2014.

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Volume XXIV No. 10 – July 17, 2017

In this issue:

IN AN EXCLUSIVE INTERVIEW, Ambry Genetics’ CEO shares details about the clinical and market strategies that led Ambry to become the target for one of the biggest lab acquisition deals in recent years by purchase price, and one of the highest-priced acquisitions of a privately-held lab company. Also, laboratory executives and pathologists preparing for 2018’s looming $400 million in Medicare Part B fee cuts will learn from this issue about the inherent bias included in the PAMA final rule that will work to the disadvantage of their labs.

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Volume XXIV No. 9 – June 26, 2017

In this issue:

FOR LAB MANAGERS WORRIED about being parceled out to a national lab, news reports that Quest Diagnostics had exited the long-running CompuNet Clinical Laboratory joint venture in Ohio is intriguing. THE DARK REPORT provides exclusive analysis of that news, provides a history of the lab joint venture, and considers the possibility of a trend in lab agreements with Quest. Also, this issue includes analysis of the trend in genetic testing pre-authorization and its impact on local labs.

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Volume XXIV No. 8 – June 5, 2017

In this issue:

IT’S A STARTLING ACHIEVEMENT: A Silicon Valley-based lab company, just two years after its founding, has become an in-network lab provider for a number of health insurers—including three of the nation’s largest payers, gaining in-network access to 100 million members. How did the firm do it? By establishing a rock-bottom price of $249 for its 30-gene test panel and building a physician-friendly portal that makes it quick and easy for doctors to meet pre-authorization requirements when ordering the test. In another article, THE DARK REPORT explains why it’s past time for labs to make more money by helping to improve outcomes — that is, adopting Clinical Lab 2.0 for the future.

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Volume XXIV No. 7 – May 15, 2017

In this issue:

IT’S GOOD NEWS AND BAD NEWS for the laboratory industry, as attested to by industry leaders at the Dark Intelligence Group’s annual Executive War College. Speakers explained in detail how the rise of precision medicine will bolster labs, and how looming Medicare cuts will hurt them. Innovation in business models is on the table, and detailed in depth by the experts in this issue.

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Volume XXIV No. 6 – April 24, 2017

In this issue:

BEYOND THE NEWS OF FDA CLEARANCE of a digital pathology system, THE DARK REPORT explains the actual impact and practical benefits of digital pathology to real-life pathology groups, such as a smoother workflow and greater profitability. Also, researchers involved in a stunning study showing a diagnostic error rate of 21% for patients referred to the Mayo Clinic explain how lab professionals can improve physicians’ diagnostic accuracy and add value to their work.

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Volume XXIV No. 5 – April 3, 2017

In this issue:

EVERY LABORATORY IN THE U.S. is watching how CMS is moving, step-by-step, to implement the final rule for private payer lab test price reporting, as mandated by PAMA. In this issue, THE DARK REPORT considers potential reasons for the agency’s recent price test reporting delay, the possibility that CMS is manipulating data to get the results it wants, and the disaster that the entire project could be for thousands of labs and their patients.

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Volume XXIV No. 4 – March 13, 2017

In this issue:

FOR LAB EXECUTIVES, 2017 is shaping up to be the year of the deal, and THE DARK REPORT is your go-to source for all the inside details of the latest lab acquisitions and laboratory sales. Read in this issue about the financial sustainability of hospital lab outreach programs. What does the future hold for hospital lab administrators and clinical pathologists?

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Volume XXIV No. 3 – February 21, 2017

In this issue:

THE DARK REPORT is first to report that the coming Medicare Part B fee cuts have begun to affect the projected financial sustainability of community labs and hospital lab outreach programs. In two articles, we cover the recent sale of PeaceHealth Laboratories to Quest Diagnostics and the transaction’s implications for the economic viability of outreach lab businesses in the future. Also, in an exceptional development, the University of Michigan Medical Center Department of Pathology is learning new ways to add value that include face-to-face meetings with patients. And, a first look on the important trend of rising salaries for pathologists and PhDs with expertise in molecular and genetic testing.

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CURRENT ISSUE

Volume XXXIII, No. 4 – March 23, 2026

A federal court ruling has established a safe harbor for clinical labs when they run tests ordered by physicians. Lab leaders should examine this briefing for pitfalls. Also, it turns out that providers may be ordering inappropriate vitamin D tests, according to one expert.

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