TAG:
specialty labs
Specialty Progresses With CA Lab Regulators
CEO SUMMARY: Earlier this month California laboratory regulators found Specialty Laboratories, Inc. to be “in substantial compliance with California clinical laboratory law.” This is an important milestone in restoring the lab company to full compliance with both state and federal labor…
Specialty Lab’s Woes Trigger Big Market Shift
IT’S THE UNPUBLICIZED STORY BEHIND THE STORY. Most of the laboratory industry knows that Specialty Laboratories, Inc. is the target of sanctions issued by both federal and state laboratory regulators. But the impact of this development has yet to be recognized across the industry. …
Specialty Labs Struggles To Maintain Operations
CEO SUMMARY: In April, Specialty Laboratories, Inc. disclosed that state and federal regulators had placed sanctions on the esoteric testing company, including revocation of its CLIA-88 license, subject to legal appeal. One main source of concern is the fact that, over the past 10 weeks, …
California Lab Regulators Are A Tough Bunch
CEO SUMMARY: By law, government regulators cannot comment publicly about the actions they take against the companies they regulate. That’s why the lab industry never learned that other public lab companies operating in California, following inspections by state authorities, were judged …
Specialty Labs Coping With Unique Challenges
CEO SUMMARY: Few laboratory executives have ever been tested as intensely as those of Specialty Laboratories, Inc. Since the first of the year, Quest Diagnostics Incorporated has purchased two of its biggest lab clients. In April, state and federal lab regulators issued sanctions. Both de…
State, Federal Regulators Target Specialty Labs
CEO SUMMARY: Specialty Laboratories, Inc. has earned the dubious honor of being the first-ever publicly-traded laboratory to have its CLIA-88 license revoked by federal regulators, terminating its right to payment for services covered by Medicare and Medicaid. The revocation is slated to …
California Is Lab Industry’s Bellwether Again
IT’S NO COINCIDENCE THAT two recent lab industry developments are centered around lab companies in California. Repeatedly that state has proven to be a valuable bellwether of lab industry trends for the nation. On the lab regulatory front, state officials from the California Department of …
“March 11, 2002 Intelligence: Late Breaking Lab News”
Down in Orlando, Florida, Cognescenti Health Institute, now opening a newly-constructed clinical laboratory, has selected LabDat, Inc. to provide browser-based lab test ordering and results reporting. In response to the anticipated changes caused by genomic and prot…
Will Esoteric Testing Soon Undergo Consolidation?
WITH EACH INSTANCE OF LAB CONSOLIDATION, the commercial lab sector of the laboratory industry comes closer to a true duopoly. Economists define duopoly as a market substantially controlled by two companies. Economists believe that a duopolistic market shares many characteristics of a monopolistic ma…
Roche, Digene, Centrex, Labtest.com, Specialty Labs, Tripath Imaging
ROCHE DIAGNOSTICS POSITIONED TO SERVE PUBLIC HEALTH LABS HEIGHTENED CONCERNS over bioterrorist attacks have accelerated plans within the public health lab sector to acquire state-of-the art diagnostic technology in DNA typing and enzyme immunoassay. Roche Diagnostics has in…
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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