TAG:
clia
Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?
CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions …
AACC reveals details of its invitation to Theranos CEO
This is an excerpt from a 925-word article in the May 23 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
Theranos in the News, for Better and Worse
IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is to disrupt the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company. During March and April, The Wall Street Jou…
Theranos Saga Just Keeps Getting More Intriguing
This is an excerpt from a 400-word article in the May 2 issue of THE DARK REPORT. The complete article is available paid members of the Dark Intelligence Group. …
February 29, 2016 Intelligence: Late Breaking Lab News
Sandy, Utah-based Sure Genomics is the latest genetic testing company to get a letter from the Food and Drug Administration asking why the company is marketing its SureDNA genetic testing kit to consumers without first obtaining clearance from the federal agency. Th…
NY Times Asks: ‘Is Lab Testing the Wild West?’
HOW MANY OF YOU SAW THE NEWS STORY PUBLISHED LAST MONTH by The Wall Street Journal with the headline, “Is Lab Testing the ‘Wild West’ of Medicine?” It is the latest in a series of news stories about issues and questions involving the accuracy and quality of clinical laboratory tests …
Despite Tough Anatomic Pathology Market, Bostwick Opens New Laboratory
CEO SUMMARY: Once again, entrepreneur and pathologist David G. Bostwick, MD, is starting up a new lab company. Granger Diagnostics is now open and is located in North Chesterfield, Virginia. It is designed to be an anatomic, clinical, and molecular pathology reference laboratory. In an ex…
New Company Tracks Details and Prices For 60,000 Molecular and Genetic Tests
CEO SUMMARY: Advances in the speed, accuracy, and cost of next-generation gene sequencing making it possible for clinical labs to create thousands of new tests. How many new tests? NextGxDx, an information technology company, says the nation’s clinical laboratories are introducing new m…
FDA Official Makes Case In Favor of LDT Guidance
CEO SUMMARY: Forty years ago, pathologists in hospital and academic labs worked closely with treating physicians to produce laboratory-developed tests for discrete clinical cases. Seeing that, the FDA decided not to regulate those tests, an FDA official said. Over time, however, use of L…
Washington Post: Theranos Approached Military in 2012
SINCE THE WALL STREET JOURNAL published its exposé of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab company’s practices. One example is the disclosure by The Wall Street …
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.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab 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!
Sign up for TDR Insider
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.