TAG:
molecular testing
35 Firms Get FDA Warning Letters Regarding Various Swine Flu Claims
By Robert Michel | From the Volume XVI No. 8 – June 8, 2009 Issue
THREE COMPANIES ADVERTISING laboratory tests for swine flu A/H1N1 were among those firms targeted for warning letters by the Food and Drug Administration (FDA) last month. Between May 4 and May 29, the FDA sent warning letters to 35 companies. The warning letter typ…
Influenza A Test Is a Help When Screening for H1N1
By Robert Michel | From the Volume XVI No. 8 – June 8, 2009 Issue
CEO SUMMARY: Viracor Laboratories is preparing to handle expanded volumes of influenza testing prior to the start of the next flu season. It will use added instrumentation and expanded working hours to expand capacity. Another strategy is to use influenza A testing as a way to re…
April 6, 2009 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XVI No. 5 – April 6, 2009 Issue
Effective May, 1, 2009, Laboratory Corporation of America will no longer be a contract provider for Regence BlueShield, head-quartered in Seattle, Washington. Regence notified physicians that it was ending its relationship with LabCorp “as a result of rising co…
2008’s Top Ten Lab Stories Lacked Disruptive Impact
By Robert Michel | From the Volume XV No. 16 – December 01, 2008 Issue
CEO SUMMARY: For the first time in recent memory, a year has passed without major tumult or disruptive change in the laboratory industry. Our list of the Top Ten Most Important Stories of 2008 reflects a rather quiet year when compared to most years of this decade. Howeve…
Growth Conundrum Confronts Quest and LabCorp
By R. Lewis Dark | From the Volume XV No. 15 – November 10, 2008 Issue
AFTER MORE THAN TWO DECADES of buying up almost every attractive laboratory asset that came up for sale—and with few lab acquisition candidates left to buy—Laboratory Corporation of America and Quest Diagnostics Incorporated find themselves in an interesting conu…
Rapid Genome Sequencing Predicted by Mid-2009
By Robert Michel | From the Volume XV No. 14 – October 20, 2008 Issue
CEO SUMMARY: In the same way that the Human Genome Project was disrupted by the entry of C. Craig Venter and Perkin-Elmer in what was then a 15-year, $3 billion project, now Complete Genetics of Mountain View, California, is disrupting the race to the $1,000 human genome sequence. Develop…
Hospital Labs Have New Options for Molecular Dx
By Robert Michel | From the Volume XV No. 14 – October 20, 2008 Issue
CEO SUMMARY: Laboratories that offer molecular assays continue to see strong growth in four areas: oncology, hematopathology, infectious diseases, and personalized medicine. Further, a new generation of molecular testing systems and analyzers is coming to market which will make it easier …
DeVry University, Retail Walk-In Clinics, NeoGenomics, Clarient, Clinical Lab Partners, Patient ID Theft
By Robert Michel | From the Volume XV No. 13 – September 29, 2008 Issue
MED TECH SHORTAGE CAUSES DEVRY UNIVERSITY TO OFFER MT DEGREE IN RESPONSE TO THE GROWING SHORTAGE of skilled lab scientists and medical technologists, DeVry University of Phoenix, Arizona, is offering a new bachelor’s degree program in Clinical Laboratory Science (…
Implementing Best Practices Across 27 Hospital Labs
By Robert Michel | From the Volume XV No. 6 – May 5, 2008 Issue
CEO SUMMARY: It is always challenging to ensure consistency and high productivity across the different labs in a consolidated lab organization. To help staff focus on quality and efficiency, Alverno Clinical Laboratories LLC uses Lean methods to improve quality and timely delivery of lab …
Ascendium Consulting Is New Firm In Lab Market
By Robert Michel | From the Volume XV No. 4 – March 24, 2008 Issue
CEO SUMMARY: Growing numbers of laboratories are taking steps to reengineer work flow, evaluate automation solutions, and improve the operational performance of their laboratory. This is fueling a demand for laboratory consulting services and Ascendium Consulting is this newest healthcare…
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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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