TAG:
FDA Clearance
Roche/Affymetrix Microarray Cleared for Clinical Use by FDA
MOLECULAR DIAGNOSTICS took a big step forward in December. During the month, the Food and Drug Administration (FDA) cleared the first microarray instrument system and microarray-based laboratory test for clinical use. The FDA announced on December 23, 2004 that it had cleared the Ge…
Applied Digital’s Verichip™, Laboratory Corp. of America
IMPLANTABLE HUMAN IDENTIFICATION CHIP CLEARED BY FDA IT’S A DEVELOPMENT THAT INVOKES images from both George Orwell’s 1984 and Aldous Huxley’s Brave New World. An implantable radio frequency identification microchip (RFID) for human use was cleared by the U.S. Food and Drug Adm…
ChromaVision Targets National AP Market
CEO SUMMARY: Three new business strategies are moving ChromaVision into different segments of the laboratory testing marketplace. The company has built a new laboratory facility and will support local pathology groups with advanced diagnostic technology. It is also expanding its presence …
Health Line Clinical Labs, ChromaVision, Cytyc, TriPath, Quest Diagnostics
HEALTH LINE CLINICAL LABS SIGNS $10 MILLION FRAUD SETTLEMENT WITH FEDS DESPITE THE EVIDENCE that packing unnecessary tests into test panels is not acceptable to Medicare and Medicaid authorities, some laboratories continue the practice. Health Line Clinical Laboratories, Inc…
Marketing Approved Kits Against “Home Brewsâ€
CEO SUMMARY: In past years, it was customary for laboratories to shift away from performing or ordering “home brew†tests in favor of FDA-approved test kits as they became available. However, new marketing models for diagnostic testing are shifting this long-standing practice. HIV res…
“April 22, 2002 Intelligence: Late Breaking Lab News”
Careside, Inc.’s point-of-care instruments for routine chemistry and hematology are moving into the clinical marketplace. (See TDR, November 22, 1999.) Through January, the company, based in Culver City, California, had placed 73 units, with another 17 on order. Careside 
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…
“November 5, 2001 Intelligence: Late Breaking Lab News”
It’s a milestone in the Pap smear testing marketplace. Cytyc Corporation, in its third quarter financial report, now claims its Thin-Prep® product has 51% of the national market for Pap testing. Estimates are that 55 million Pap tests are done annually in the United States. A 51% …
“November 13, 2000 Intelligence: Late Breaking Lab News”
Last Thursday was the day Dynacare, Inc. hoped to place its initial public offering. Dynacare seeks to raise as much as $89 million…
Accurate Costing of New Pap Technology Proves Interesting
CEO SUMMARY: Various new technologies intended to supplant conventional Pap smear screening must deliver improved clinical performance in a cost-effective manner. Joseph Plandowski, our guest writer,concludes his three-part series on new Pap smear technologies by evaluating actual lab cos…
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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