TAG:
lab executive
FDA Notifies Congress that It Will Regulate LDTs
By Joseph Burns | From the Volume XXI No. 11 – August 11, 2014 Issue
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
My Visit to Walgreens for Theranos Lab Tests
By Robert Michel | From the Volume XXI No. 11 – August 11, 2014 Issue
CEO SUMMARY: One of the biggest unknowns in the lab testing industry today is Theranos, the lab testing company based in Palo Alto, California. It says its proprietary technology is poised to transform the lab testing experience for patients and physicians. It says it can perform hundreds…
Ignoring Lab Industry, Theranos Goes Its Way
By Robert Michel | From the Volume XXI No. 11 – August 11, 2014 Issue
CEO SUMMARY: With each passing month, Theranos pulls open the curtain a bit more on its business structure and its market growth plans. Its clinical lab tests are now offered in Walgreens pharmacies in Palo Alto, California, and Phoenix, Arizona. Recent news coverage in Fortune and USATod…
Test Utilization Targeted by UnitedHealth, LabCorp
By Joseph Burns | From the Volume XXI No. 10 – July 21, 2014 Issue
CEO SUMMARY: Many independent laboratories serving patients in Florida are unhappy about the decision by UnitedHealth (UNH) to initiate a pilot program that calls for LabCorp’s BeaconLBS subsidiary to handle prior authorization for certain lab tests. UNH’s laboratory benefit managemen…
Labs Wary of BeaconLBS, Express Major Concerns
By Joseph Burns | From the Volume XXI No. 10 – July 21, 2014 Issue
CEO SUMMARY: Lab executives asked to join UnitedHealth’s new BeaconLBS lab benefit management system soon to launch in Florida have multiple and serious concerns. The primary issue is that BeaconLBS is a subsidiary of LabCorp—their major competitor. These executives understand why a p…
Dealing with Realities of Changing Market
By Joseph Burns | From the Volume XXI No. 10 – July 21, 2014 Issue
CEO SUMMARY: Swift transformation of the American healthcare system is causing financial challenges for those clinical labs and pathology groups that have been slow to react to these developments. At NorDx Laboratories in Scarborough, Maine, the team is following the classic five rules fo…
At Mid-Year, Labs Struggle to Get Paid for Many Tests
By Joseph Burns | From the Volume XXI No. 10 – July 21, 2014 Issue
CEO SUMMARY: At a recent coding and billing conference, pathology and lab clients of one of the nation’s largest revenue management companies agreed that three trends have caused lower revenues since the start of 2014. One trend seen by labs involves higher deductibles and copayments fr…
Survival Essentials for Local Labs
By R. Lewis Dark | From the Volume XXI No. 9 – June 30, 2014 Issue
IF THERE IS ANY SINGLE SIGN OF TOUGH TIMES FOR LOCAL LABS, it is decreasing access to patients due to the exclusionary contracting tactic of health insurers. That tactic is the …
Excluding Lab Competitors Helps Big Labs Grab Greater Market Share
By Joseph Burns | From the Volume XXI No. 9 – June 30, 2014 Issue
CEO SUMMARY: Changes in healthcare are motivating health insurers and the nation’s largest lab testing companies to enter into contracts in which the large lab company lowers its lab test prices to the payer in return for having the payer exclude that lab company’s toughest competitor…
Futurist Predicts Less Margin, More Consolidation in Market
By Joseph Burns | From the Volume XXI No. 9 – June 30, 2014 Issue
CEO SUMMARY: Based on interviews with 40 CEOs of major healthcare companies, one expert says that the next three years will bring major changes to healthcare. In his presentation at the Executive War College, Ted Schwab noted that these changes include a swift adoption of budgeted care (a…
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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