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clia
Much Disruption for Labs In 2016’s Top 10 Stories
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…
Labs Have Heavy Burden to Report Lab Price Data
CEO SUMMARY: Clinical labs must assess their responsibilities to report lab test market prices to CMS as part of the Protecting Access to Medicare Act. A panel of three experts took up this topic at a recent webinar hosted by THE DARK REPORT. On June 23, the federal Centers for Medicaid &…
FDA Official Outlines Need for Federal Regulation of LDTs
AT A CONGRESSIONAL BRIEFING LAST WEEK, a federal official charged with regulating laboratory-developed tests made the case that LDTs are inconsistently reliable and thus put patients at risk, according to MedPage Today. “If you take the same patient sample and you send it to different la…
Theranos Ends Patient Testing, Sued for Deceiving Investors
IN THE EARLY 1960S, the great bluesman Albert King wrote, “Born Under a Bad Sign,” which contained the unforgettable lyric, “If it wasn’t for bad luck, I wouldn’t have no luck at all.” That lyric almost describes what’s happened to Theranos Inc. since October 2015. Al…
Brooklyn Toxicology Lab Suspended for 30 Days by NY Department of Health
IN BROOKLYN, N.Y., a toxicology laboratory has been shut down temporarily since Sept. 9 by order of the New York State Department of Health. The lab was cited for failing to perform calibration and quality control procedures properly, The lab company is Advanced Clinical Laboratory Solutions…
Attorney Jane Pine Wood to Be Chief Legal Counsel at Bio-Reference
One of the most widely-respected and trusted attorneys serving the clinical laboratory industry and anatomic pathology profession is leaving private practice to join the corporate world. …
First CAP 15189 Accreditation for a Children’s Hospital Lab
CEO SUMMARY: It’s now official. St. Jude Children’s Research Hospital is the first children’s hospital to earn accreditation to ISO 15189 under the College of American Pathologists. What is more interesting, however, is how lab leadership used the quality management system of ISO 15…
Score for Theranos after AACC: Fail.
This is an excerpt from a 1,600-word article in the August 15 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press
CEO SUMMARY: Elizabeth Holmes, Founder and CEO of Theranos, Inc., was given the ideal platform by AACC to show the science behind her lab company’s much-touted diagnostic technologies. But in a surprise to the assembled audience, Holmes, accompanied by three PhDs on her team, chose to d…
July 25, 2016 Intelligence: Late Breaking Lab News
Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This …
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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