TAG:
clinical trials
California Pathology Labs to Report Data to State’s Cancer Registry
HEALTHCARE BIG DATA IS ADVANCING in California and all pathologists in the Golden State will be required to submit data to the state’s cancer registry beginning in 2019. California’s new law to support the state’s cancer registry is the latest example of an effort to ensure the timely collecti…
Digital Pathology Can Be Transformative for Labs
CEO SUMMARY: Across the nation, pathologists are at a crossroads. Now that the FDA has cleared a digital pathology and whole slide imaging (WSI) system for use in primary diagnosis, should they adopt this technology sooner or wait until later? One pathologist who has worked with WSI for m…
CEO Describes Characteristics Of the Clinical Lab 2.0 Model
CEO SUMMARY: Moving away from volume-based care will not be easy for clinical labs. After all, high volume sustains labs. But labs seeking to transition away from fee-for-service to value-based care must have a seat at the table where decisions are made, said a lab CEO who is part of Proj…
LabCorp Now Larger than Quest, Two Labs Report 2015 Earnings
IN RECENT WEEKS, the nation’s two largest lab companies reported fourth quarter and full-year earnings for 2015. The earnings reports reveal how the paths of the two companies are diverging. The companies are diverging because of a major acquisition made in February 2015, by Laboratory Cor…
FDA Official Makes Case In Favor of LDT Guidance
CEO SUMMARY: Forty years ago, pathologists in hospital and academic labs worked closely with treating physicians to produce laboratory-developed tests for discrete clinical cases. Seeing that, the FDA decided not to regulate those tests, an FDA official said. Over time, however, use of L…
Might Lawsuits Come Next in Theranos Story?
CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal c…
NeoGenomics to Acquire Clarient for $275 Million
CEO SUMMARY: In a surprise move that further consolidates national anatomic pathology services, NeoGenomics will acquire Clarient Inc., from General Electric Healthcare. General Electric is getting cash, and preferred and common stock. The two companies announced plans to pursue integrate…
LabCorp, Sysmex Will Collaborate To Develop Liquid Biopsy Tests
ANOTHER SIGN OF HEALTHCARE’S TRANSFORMATION came on June 1 when Sysmex Corporation of Kobe, Japan, and Laboratory Corporation of America in Burlington, North Carolina, announced a unique collaboration to develop blood-based molecular diagnostic tests for cancer. The collaboration call…
Leveraging Testing Technology To Identify MRSA, C. Difficile
CEO SUMMARY: Probably the most challenging infections for hospitals to control and reduce are methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile (C. diff). The laboratory at one New York hospital introduced algorithms to screen for the presence of each i…
February 17 Intelligence: Late Breaking Lab News
GeneCentric is a new lab testing company in Durham, North Carolina that was started by former executives of Laboratory Corporation of America. It intends to raise $20 million in a Series B capital offering. GeneCentric’s business model is to license molecular diagnostic tests, then develop the…
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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