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LabCorp
New Type of Competition from Investor-Owned Labs
By Robert Michel | From the Volume XXXI, No. 9 – July 1, 2024 Issue
CEO SUMMARY: More investor-funded lab companies see robust future growth in serving what The Washington Post calls “a booming online wellness market that aims to leave the doctor’s office behind. ” This is a new market driven by younger health care-minded consumers who turn to …
Is It Time for Clinical Labs to Embrace Consumers?
By R. Lewis Dark | From the Volume XXXI, No. 9 – July 1, 2024 Issue
HEALTHCARE IN THIS COUNTRY HAS A WELL-D…
ACLA Files Court Challenge to FDA’s Final LDT Rule
By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue
CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.†ACLA and HealthTrackRx are challenging the FDA’s  
ACLA President Van Meter Discusses LDT Lawsuit
By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue
CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…
June 10, 2024, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue
Once a high-flier lab test manufacturer with a market valuation of $2 billion, Cue Health of San Diego filed for Chapter 7 bankruptcy on May 28. Analysts now say the company is valued at about $15 million. Founded in 2010, Cue Health was developing a test system that consumers could …
Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCU…
Labcorp to Acquire Only Certain Lab Assets of OPKO’s BioReference
By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue
Following Labcorp’s announcement that it will acquire “select assets†of BioR…
April 29, 2024, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue
It may be that the genetic data cat is out of the bag already. Nonetheless, lawmakers in Delaware are considering a bill that—among other things—would prevent life insurance companies from buying or using genetic testing data if it was obtained from ancestry companies and not from medical records…
FDA Issues Memo to Reclassify Many High Risk IVD Assays
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
Walgreens to Close 60 VillageMD Locations
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
CEO SUMMARY: Following substantial losses in fiscal 2023, Walgreens is working to cut costs and reduce overhead. One casualty in this effort will be the closure of 60 of the 360 primary care clinics in retail pharmacy stores built by Walgreens in recent years. These actions demonstrate th…
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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