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Influenza A/H1N1 Outbreak Offers Lessons for Labs
By Robert Michel | From the Volume XVI No. 8 – June 8, 2009 Issue
CEO SUMMARY: As influenza A/H1N1 spread, clinical labs nationwide learned that they did not have the capacity to test for an outbreak of flu that generated a 10-fold increase in sample volume. To move the samples through the system, many clinical labs ran extra shifts and ran sho…
Need Rigorous Validation For Home Brew Assays
By Robert Michel | From the Volume XVI No. 3 – February 23, 2009 Issue
CEO SUMMARY: National headlines about erroneous Vitamin D results are a reminder to the lab industry of the imprecision and risks associated with home brew testing. According to one laboratory expert, every laboratory-developed test (LDT) must meet two high standards. On…
Denver’s UniPath Sells Its Histo Labs to APP
CEO SUMMARY: UniPath ended a long search for a business partner with ample capital and resources to help it continue its aggressive rates of growth in specimen volume, market share, and revenue. UniPath announced the sale of its technical laboratories to American Pathology Partne…
Inaccurate Results + Quest Dominates News Cycle
By R. Lewis Dark | From the Volume XVI No. 1 – January 12, 2009 Issue
CEO SUMMARY: Most laboratory professionals don’t know it yet, but significant changes occurred to the entire lab industry last week. After Quest Diagnostics Incorporated acknowledged that it was retesting tens of thousands of patients because 7% of the Vitamin D results it repo…
Lab Conserves Blood When Drawing Patients
By Robert Michel | From the Volume XVI No. 1 – January 12, 2009 Issue
CEO SUMMARY: New attention on both the risks associated with blood transfusions and the cost of blood products is triggering action by the nation’s hospitals. At the 719-bed Rhode Island Hospital, the laboratory is on the front line of the hospital’s blood management initiative. One c…
Momentum Continues for Digital Pathology
By Robert Michel | From the Volume XV No. 16 – December 01, 2008 Issue
CEO SUMMARY: Last month, digital imaging in pathology gained additional momentum with the latest FDA clearance. Aperio Technologies, Inc., now has FDA clearance to market its slide scanning system for reading digital progesterone receptor (PR) slides on a computer monitor. Aperio plans to…
Multi-Modality Diagnosis Heading for Lab Medicine
By Robert Michel | From the Volume XV No. 16 – December 01, 2008 Issue
CEO Summary: At the upcoming Molecular Summit in Philadelphia on February 10-11, 2009, pathologists, molecular imaging experts, and informaticians will share the latest developments on the integration of in vivo (imaging) and in vitro (pathology) diagnost…
December 01, 2008 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XV No. 16 – December 01, 2008 Issue
Having grown to over $1 billion in revenue, Inverness Medical Innovations, Inc. of Waltham, Massachusetts, is newest of the in vitro diagnostics (IVD) companies to achieve size and scale. One of its more interesting products is an in-home system that allows …
LabCorp And Quest Report 3rd Quarter Financial Performance
By Robert Michel | From the Volume XV No. 15 – November 10, 2008 Issue
CEO Summary: In third quarter earnings reports, both national lab companies posted modest gains in specimen volume, revenue, and net profit. More telling is the relative quiet in the current market for lab testing services. With no obvious opportunities to fuel double-digit rates of growt…
Cytology Lab Uses Lean to Simplify Processes
By Robert Michel | From the Volume XV No. 15 – November 10, 2008 Issue
CEO SUMMARY: Like many labs today, the gynecologic cytology laboratory at the University of Iowa Hospitals and Clinics had a pre- and post-analytical work flow with many complex steps. This work flow—heavily influenced by a legacy of previous information systems—was inefficient, conta…
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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