TAG:
accredited lab
French Company Buys Pittsburgh-Based RedPath
CEO SUMMARY: Here’s a deal that is all about proprietary molecular assays and access to new markets. With its purchase of RedPath Integrated Pathology, ExonHit Therapeutics, S.A., of Paris, France, gains a CLIA laboratory and access to the U.S. market, even as the new owner ope…
First U.S. Labs Nearing ISO:15189 Accreditation
CEO SUMMARY: Laboratories, hospitals, and other health-care providers in the United States will increasingly be required to adopt quality management systems (QMS) as part of their regular operational routine. This is consistent with trends in other developed countries. Several U.S. labora…
MT/MLT Distance Learning Goal of Collaboration
CEO SUMMARY: To encourage more students to pursue medical technology (MT) and medical laboratory technician (MLT) degrees, ARUP Laboratories and Weber State University (WSU) are collaborating to promote the distance learning programs offered at WSU. Online students can work any shift and …
ISO 15189 Work Advances at Meeting in Vancouver
CEO SUMMARY: Laboring quietly out of the public eye, an international work team of professionals, including representatives from the CDC, the FDA, and global in vitro diagnostics (IVD) manufacturers, has spent the past 14 years developing an important series of quality and safety standard…
Labs Should Prepare for Tighter CLIA Enforcement
CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of p…
Lab “Day of Disaster” Provides Useful Lessons
CEO SUMMARY: On Friday, May 5, laboratory administrators and pathologists who guided their labs through some of the nation’s biggest natural disasters and emergencies will gather in Miami to share their experiences in contingency planning and disaster response. It is no understatement t…
FL Medicaid Lab Bid Gets Slammed By Foes
CEO SUMMARY: Florida laboratories were caught by surprise last month when state Medicaid officials announced a 28-day process to award one lab with the state’s non-hospital Medicaid testing. To fight this RFP, a growing coalition of laboratories, lab industry trade groups, and the Flori…
LabCorp Making Steady Progress On Path Back to Financial Health
MOST OF THE LAB INDUSTRY is watching the impending acquisition by Quest Diagnostics Incorporated of SmithKline Beecham Clinical Laboratories (SBCL). This big news overshadows the steady gains made at Laboratory Corporation of America in its efforts …
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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