TAG:
FDA Clearance
FDA Clears Digital Path for Primary Diagnosis
CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone on April 12 when the FDA cleared the Philips digital pathology system for sale in the United States. Now pathologists can use the system to perform primary diagnoses and get paid for those pr…
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…
Of Theranos, ADLTs, and Surgical Pathology Errors
THESE DAYS, IT SURE FEELS LIKE CLINICAL LABS AND PATHOLOGY GROUPS are under constant siege. Every month seems to bring one or more new developments that rock the clinical lab industry. Thera…
What will the future hold for Theranos?
This is an excerpt from a 1,900-word article in the July 25 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
Theranos Now Scrambling To Save What It Can
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
June 13, 2016 Intelligence: Late Breaking Lab News
Life insurers are adopting healthcare big data as part of their underwriting process and clinical laboratory test data has an important role. Quest Diagnostics Incorporated participates in this business line. Huffington Post recently published a story on this topic and ident…
Washington Post: Theranos Approached Military in 2012
SINCE THE WALL STREET JOURNAL published its exposé of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab company’s practices. One example is the disclosure by The Wall Street …
Lab Professionals Long Knew of Challenges at Theranos
CEO SUMMARY: As THE DARK REPORT has continually reported, pathologists and medical laboratory professionals in the San Francisco and Phoenix markets were aware for most of the past year that Theranos was not delivering to patients and consumers the specific lab testing services it regula…
Lab Professionals Knew of Challenges at Theranos
CEO SUMMARY: For most of the past year, pathologists and medical laboratory professionals in the San Francisco and Phoenix markets were aware that Theranos was not delivering to patients and consumers the specific lab testing services it regularly touted in news stories and at conferences…
Theranos, Capital Blue Sign Lab Test Agreement
CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health ins…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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