Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995
The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.
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.
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.
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.
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.
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.
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.
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.
IT’S A TALE OF TWO LABS: One saw the handwriting on the wall and took steps to successfully stay in business by producing value-added outcomes. The other was forced to sell its outreach business to Quest Diagnostics. THE DARK REPORT outlines how each lab responded to pressures on their business to stay afloat. Also included in this issue are the details of how a manager of an opioid treatment center in Kentucky pleaded guilty recently to three counts under EKRA: soliciting a bribe, making a false statement, and attempting to tamper with evidence.
THE DARK REPORT EXAMINES how using cheap offshore billing companies might come back to bite clinical labs, which are turning to these companies to cut costs in an increasingly stressful business climate. Also in this issue is an insider look at how 33 industry groups came together to help get the Laboratory Access for Beneficiaries (LAB) Act passed, which will relieve some of the most onerous burdens imposed by Protecting Access to Medicare Act of 2016.
WILL CLINICAL LABS BE EXCLUDED from the new proposed safe harbors under the Stark Act and the AKS? THE DARK REPORT analyzes the problem and also the warning that lies within CMS’ plans for revisions to the anti-fraud laws. Also in this issue are key health system strategies and lab objectives from inside the highly successful switch to value-based medicine at one hospital lab, which was once considered a candidate for sale.
Get the most expert business intelligence for clinical laboratories and pathology groups available today. Subscribe to The Dark Report.
Volume XXXII, No. 12 – August 25, 2025
In an exclusive interview, a laboratory industry M&A specialist discusses what’s driving lab outreach sales to national lab companies. Also, The Dark Report analyzes ways in which pathology and clinical labs can profitably partner with pharmaceutical companies.
See the full table of contentsLab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.
The Dark Report
1000 N West Street, Suite 1200 Wilmington, Delaware, United States, 19801
Phone: 512-264-7103
Email: info@darkreport.com
© 2025 The Dark Report. All rights reserved. Part of the LabX Media Group