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Issues Archive

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

Volume XXIII No. 13 – September 26, 2016

In this issue:

IT’S NEVER BEEN DONE BEFORE: In a story reported to the laboratory industry only in THE DARK REPORT, and for the first time ever in a case of alleged lab fraud, the bankruptcy trustee in the Health Diagnostics Lab case is seeking the return of all funds that changed hands illegally — from HDL executives, shareholders and sales consultants, to the physicians who accepted inducements from the company. Also, the lab profession will be surprised to learn of attorney Jane Pine Wood’s departure from private practice to work for a corporation, leaving hundreds of clients without her respected and expert legal acumen.

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Volume XXIII No. 12 – September 6, 2016

In this issue:

THE DARK REPORT IS THE ONLY RESOURCE IN THE INDUSTRY to both recognize the immense significance to the entire lab industry of the Safeway reference pricing program — and how it drove down the cost of lab testing to Safeway and its employees by 32% in just 36 months — and to provide a “take-to-the-bank” comprehensive analysis of the study in JAMA Internal Medicine that delivers all the implications of reference pricing. This issue is designed to help Dark Intelligence Group members craft appropriate strategies for their organizations so they can respond to this latest threat to laboratory revenue if and when it arrives in their communities.

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Volume XXIII No. 11 – August 15, 2016

In this issue:

THE DARK REPORT WAS ON THE SCENE when Elizabeth Holmes made her big debut in front of industry scientists, and analyzes the reaction in this issue. Also, THE DARK REPORT has uncovered the latest threat to incomes for anatomic pathologists, as a new reimbursement scheme via MACRA is set to launch in January; and the issue also includes insights and predictions about how pathologists should understand and respond to several other important pathology marketplace developments.

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Volume XXIII No. 10 – July 25, 2016

In this issue:

BY NOW, MANY LAB PROFESSIONALS KNOW CMS sent a letter to Theranos in early July that imposed multiple CLIA sanctions on the beleaguered laboratory company. In this issue, THE DARK REPORT provides informed analysis, along with its expert prediction that Theranos may be preparing to abandon its clinical lab testing and direct-to-consumer strategies in favor of a new strategy involving in vitro diagnostics (IVD). Also in the issue is an exclusive interview with two attorneys recognized for their expertise in clinical lab laws and compliance, who note that the Theranos letter differs markedly  from other lab sanction letters they have seen − and seems to give Theranos some surprising options.

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Volume XXIII No. 9 – July 5, 2016

In this issue:

THIS ISSUE FEATURES THE ONLY INDUSTRY ANALYSIS of the actual on-the-ground impact of the recently-released PAMA rule containing a lab test market price reporting mandate: CMS apparently will be choosing new lab winners and losers as a consequence of the financial impact of this rule. In addition, THE DARK REPORT delivers further unique analysis of the likely negative consequences of implementation of the PAMA rule as it stands, an outlook of critical import to managers of independent local labs, community labs, and hospital outreach labs as they begin strategic planning to prepare for these fee cuts.

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Volume XXIII No. 8 – June 13, 2016

In this issue:

AS THIS ISSUE OF THE DARK REPORT went to press, it was learned that Walgreens had announced termination of its lab testing agreement with Theranos, effective immediately. Theranos loses access to about 40 Walgreens pharmacies in Phoenix. Also, in a DARK REPORT exclusive, administrators and senior managers of hospital labs should take note of Quest’s new agreement to manage labs for a major healthcare system — the second such deal in six months for Quest. These deals threaten the control and independence of hospital lab managers.

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Volume XXIII No. 7 – May 23, 2016

In this issue:

IF LAB PROFESSIONALS WERE WONDERING why Theranos is suddenly—after 13 years of essentially ignoring the profession of lab medicine—starting to engage with clinical laboratory professionals, this exclusive DARK REPORT intelligence briefing has the answers. And in another lab industry exclusive, AACC leaders tell THE DARK REPORT how Theranos CEO Elizabeth Holmes came to be invited to present scientific data at the upcoming AACC annual conference in July.

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Volume XXIII No. 6 – May 2, 2016

In this issue:

THE DARK REPORT DELIVERS strategic insights about significant trends in the clinical lab marketplace and healthcare that are essential for labs to incorporate into their clinical, financial, and operational planning. Also provided are examples of how first-rank lab innovators are successfully adapting to these trends with lab testing services that deliver enriched value to hospitals, physicians, patients, and payers.

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Volume XXIII No. 5 – April 11, 2016

In this issue:

AS THE LABORATORY INDUSTRY AWAITS any visible progress in a final PAMA lab market pricing reporting requirement rule from CMS, evidence from California shows that such reporting might be even more problematic than labs have been warning. THE DARK REPORT is the only lab industry news source to report that just 9% of clinical labs there submitted data to the state Department of Health Care Services for its rate-setting program. Also, THE DARK REPORT analyzes the difficulties that payers are having in meeting requests for coverage determinations for genetic tests.

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Volume XXIII No. 4 – March 21, 2016

In this issue:

IN AN EXCLUSIVE DARK REPORT interview, James Fantus, former CEO of one of the most successful hospital lab outreach businesses in the United States, outlines three significant trends he sees unfolding in the Northeast: a shrinking number of physician customers for labs; a rising number of patients with high-deductible health plans, resulting in lower lab test utilization; and increased competition from national labs that force regional labs to match the large labs’ prices just to remain in contention for hospital and health plan contracts. Also, UnitedHealthcare is warning labs not to waive patient fees, on penalty of lawsuits.

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CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025

Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.

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