TAG:
FDA Clearance
Mass Spectrometry Is Finding Larger Role in Clinical Labs
CEO SUMMARY: Mass spectrometry is a diagnostic technology that is transforming clinical labs and improving care at a rapid pace. The current generation of instruments is capable of supporting a faster time-to-answer and provides improved accuracy and specificity over many existing methods…
January 22, 2013 “Intelligence: Late Breaking Lab News”
Not-for-profit Boston Children’s Hospital will have majority interest in a new lab testing company. Claritas Genomics will be based in Waltham, Massachusetts, and will develop genetic and molecular diagnostic testing solutions. Life Technologies Corporation…
Considering Full versus Partial Adoption of Digital Pathology
CEO SUMMARY: Digital pathology is considered to be one of the more disruptive technologies now finding acceptance in anatomic pathology. Since founding Aperio Technologies, Inc., of Vista, California, in 1999, President Dirk G. Soenksen, M.S., M.B.A., has been in the forefront of this imp…
Lawyers Provide Insights About Top Legal Concerns
CEO SUMMARY: After conducting the first-ever survey of the most important legal, compliance and managed care concerns for clinical labs and pathology groups, THE DARK REPORT asked leading lab industry attorneys who participated in the survey to say a few words about these topics….
Quality Strategy Earns Honor for SD Laboratory
CEO SUMMARY: Here’s a new lab product launch with a surprise twist. Upon earning FDA clearance for its new HIV Ag/Ab Combo Assay this spring, Abbott Diagnostics selected a hospital laboratory in Sioux Falls, South Dakota, to be the nation’s first clinical lab to offer the ass…
Lab Industry Unprepared For FDA Action on LDTs
CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by …
August 23, 2010 “Intelligence: Late Breaking Lab News”
With the goal of developing biomarkers useful in diagnosing a variety of cancers, Pathwork Diagnostics, Inc., and Novartis AG announced a research partnership on July 30. It is an early example of a collaboration between a diagnostics company and a pharmaceutical com…
Genetic Testing Genie Is Now Out of the Bottle
CEO SUMMARY: There’s been an uneasy standoff between companies that want to sell genetic tests directly to consumers over the Internet and both state and federal regulators. But now it appears that the FDA is ready to take off the gloves and assert greater control over genetic …
Vitamin D Test Issues Trigger Doctor Discussion
CEO SUMMARY: In recent months, Quest Diagnostics Incorporated quietly launched a campaign to notify certain patients and their physicians that they had received “inaccurate results” for Vitamin D tests it had performed. This notice includes an offer to retest the patient at no charge….
Vitamin D Test Expert Discusses Mass Spec
CEO SUMMARY: Those labs performing Vitamin 25(OH) D testing by mass spectrometry face an interesting challenge. For more than two decades, physicians, patients, and a majority of credible clinical studies have accepted RIA and IA Vitamin 25(OH) D results as a familiar standard. That is wh…
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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