TAG:
companion diagnostic test
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
Why Pharma, Private Equity Want to Reshape Lab Industry
CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professio…
A coming transformation: Control over important diagnostic technologies is about to change hands
This is an excerpt from a 2,920-word article in the March 26, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: He…
Detroit Hospital Develops 10 Ways To Add More Value
CEO SUMMARY: Clinical labs are beginning to make the transition from a volume-based financial model to a model based on value-based payments. To survive this transition, labs must find ways to create value. The lab at Henry Ford Health System has identified 10 ways that it c…
Unprecedented Growth Rates for Molecular Testing
CEO SUMMARY: There will be an expanding role for innovative clinical labs as healthcare moves forward on its path toward personalized medicine. However, to capitalize on this opportunity, pathology groups and clinical labs will need to beef up their information systems. They will also nee…
Pathologists Can Offer ‘Companion Informatics’
CEO SUMMARY: Community hospitals are recognizing increased interest in personalized medicine among consumers. One expert predicts that this will create opportunities for hospital labs and pathology groups to add value by offering subspecialty expertise in molecular diagnostics, genetic te…
“Primary-Care Pathology” One Goal at Beth Israel
CEO SUMMARY: In a pioneering collaboration, the pathology department at Beth Israel Deaconess Medical Center in Boston, Massachusetts, will work with GenomeQuest, Inc., to perform whole genome sequencing of tumor specimens. GenomeQuest will handle sequencing, assembly, and annota…
Preparing for New Lab Role In Personalized Medicine
CEO SUMMARY: Laboratory medicine is about to find itself between the two jaws of a powerful vise. One jaw is pending major legislative overhaul of the entire healthcare system, along with dwindling reimbursement as Medicare and Medicaid runs out of money. The other jaw is personalized med…
Pathology, Inc. Sells Equity to Raise Capital
CEO SUMMARY: In looking how to propel its business to the next level, the partners at Pathology, Inc., opted not to sell their pathology group practice. Instead, they chose to raise capital by selling equity in their company to a group of investors. In this exclusive interview, executives…
CURRENT ISSUE
Volume XXXII, No. 9 – June 23, 2025
In part one of an analysis about the state of AI in clinical laboratories, The Dark Report explores how frontline workers, especially younger ones, are using AI tools like ChatGPT far more than lab leaders. Recent reports elsewhere in the business world show executives underestimate staff AI use, raising concerns about a leadership gap in tech adoption. Clinical lab leaders must get more familiar with AI use cases. Also, in this issue of The Dark Report, there is discussion on how Medicaid cuts may affect clinical labs, an examination of the lab industry fallout from CLIAC termination, an analysis of AMP’s reports that provide crucial insights for Hiring Managers, and notes that regional health systems are new dominant players in M&A.
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