Issues Archive

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

Volume XXVII No. 13 – September 14, 2020

In this issue:

THE DARK REPORT IS VIEWING THE FUTURE of the lab industry, and it’s clear that things will be different post-pandemic. Four trends will take shape in the coming months and years which lab professionals must bear in mind as they wrestle with everything the pandemic has wrought. Also, lab industry entrepreneurs are leveraging the pandemic situation in ways that lab managers must be aware of in order to secure their organization’s own position in the industry.

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Volume XXVII, No. 12 – August 24, 2020

In this issue:

THE DARK REPORT lines up its top lab industry experts to analyze a surprising development: The department of Health and Human Services’ welcome announcement that the Food and Drug Administration does not need to issue an Emergency Use Authorization for laboratory-developed tests. This announcement is significant because EUAs for LDTs have been a long-running irritant to labs. But lab managers will want to consider whether liability issues make a voluntary EUA advisable, based on TDR’s analysis.

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Volume XXVII, No. 11 – August 3, 2020

In this issue:

WILL RETAIL BEHEMOTH AMAZON become a competitor in the clinical lab industry? With its plans to build COVID-19 testing labs and history of disrupting the marketplace, this is a distinct possibility, and it’s not just THE DARK REPORT that thinks so. Also, UHC is about to do some disrupting of its own with its new test code protocol.

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Volume XXVII No. 10 – July 13, 2020

In this issue:

IS POOLED TESTING the answer to COVID-19 testing shortages? Yes and no. THE DARK REPORT analyzes the pros and cons of this suddenly-popular old idea, with experts from across the industry offering their input. Also in this issue is the case for why local labs should be getting more testing supplies, and how the government has damaged the supply chain.

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Volume XXVII No. 9 – June 22, 2020

In this issue:

THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.

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Volume XXVII No. 8 – June 1, 2020

In this issue:

THE DARK REPORT brings news that the national media has overlooked: Lab revenues, cut precipitously during the coronavirus pandemic, will leave many labs without the resources to continue operation in the near future. As calculated by THE DARK REPORT, the nation’s clinical lab industry had lost $6.8 billion in revenue by week 12 of the crisis. Also reported is that in many cases, the culprit is a frustrating lack of supplies that would allow labs to replace lost routine testing with new COVID-19 testing.

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Volume XXVII No. 7 – May 11, 2020

In this issue:

LABS CAN REST EASIER knowing that the initial flood of unvalidated faulty or fraudulent serological COVID-19 tests is being halted now that the FDA has done an about-face on its policies. And THE DARK REPORT offers behind-the-scenes insights into the COVID-19 Testing Project which used a multidisciplinary effort to analyze and compare the performance of 12 of these tests. In other good news, THE DARK REPORT reports on a potential new revenue source for cash-strapped labs.

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Volume XXVII No. 6 – April 20, 2020

In this issue:

COVID-19 NEWS IS HITTING the laboratory industry hard. With specimens — and therefore revenues — in a deep dive, lab finances are crashing, and COVID-19 testing isn’t entirely making up for the losses. But THE DARK REPORT shows labs how and where to apply for financial aid under federal relief packages. Meanwhile, a pre-eminent pathologist takes readers deep inside the Italian pandemic in an exclusive interview.

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Volume XXVII No. 5 – March 30, 2020

In this issue:

AS THE CORONAVIRUS PANDEMIC roars through the United States, THE DARK REPORT delivers an unprecedented look from the front lines of the medical battlefield. The lab at the “epicenter of the epicenter” of the American epidemic shares its strategies and lessons learned exclusively with TDR, and the editorial team interviewed several leading pathologists who are battling the disease around the world.

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Volume XXVII No. 4 – March 9, 2020

In this issue:

CORONAVIRUS HITS THE LAB INDUSTRY especially hard, and THE DARK REPORT is behind the scenes to document early successes. These include the rapid validation of virus tests and the adaption of a mobile phlebotomy lab program to COVID-19 testing by one lab in the heart of the New York pandemic. In non-COVID-19 news, some commercial payers and state Medicaid programs are not paying for new proprietary laboratory analyses (PLA) codes and multianalyte assays with algorithmic analyses (MAAA) codes.

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