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laboratory director
Cigna Expands Program For Genetic Counseling When Genetic Tests Are Needed
By Joseph Burns | From the Volume XXIII No. 11 – August 15, 2016 Issue
CEO SUMMARY: For three years, Cigna has required genetic counseling for members seeking genetic testing for hereditary breast, ovarian, and colorectal cancer, and for a particular heart condition. Such counseling increased member satisfaction, causing Cigna to expand the program. It now r…
Florida Pathology Group Lost Volume After BeaconLBS Started
By Joseph Burns | From the Volume XXIII No. 9 – July 5, 2016 Issue
CEO SUMMARY: A 22-physician pathology group in Tampa has complied with rules for lab test ordering that UnitedHealthcare and BeaconLBS established, yet has experienced a steep decline in the volume of specimens it receives. Physicians told the pathologists that other labs were not using t…
Lab, Emergency Department at Cleveland Clinic Collaborate to Reduce Hemolysis Rates
By Joseph Burns | From the Volume XXIII No. 7 – May 23, 2016 Issue
CEO SUMMARY: Two years ago, the rate of hemolysis in blood drawn in the Cleveland Clinic’s Emergency Department was about nine times higher than the ASCP recommended rate of 2%. With a two-year cooperative agreement and funding from the federal Centers for Disease Control and Prevention…
Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?
By Robert Michel | From the Volume XXIII No. 7 – May 23, 2016 Issue
CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions …
Theranos Saga Just Keeps Getting More Intriguing
By Mary Van Doren | From the Volume XXIII No. 6 – May 2, 2016 Issue
This is an excerpt from a 400-word article in the May 2 issue of THE DARK REPORT. The complete article is available paid members of the Dark Intelligence Group. …
At FDA, Laboratory-Developed Tests Are in the Crosshairs
By Mary Van Doren | From the Volume XXIII No. 4 – March 21, 2016 Issue
This article is an excerpt from a 600-word article in the March 21 issue of THE DARK REPORT. Full details of FDA’s laboratory-developed test guidance and recent actions against labs that are marketing LDTs are included in the original article, available to paid m…
FDA Steps Up Test Enforcement, Saying Tests Need Clearance
By Joseph Burns | From the Volume XXIII No. 4 – March 21, 2016 Issue
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New Company Tracks Details and Prices For 60,000 Molecular and Genetic Tests
By Joseph Burns | From the Volume XXIII, No. 1 – January 19, 2016 Issue
CEO SUMMARY: Advances in the speed, accuracy, and cost of next-generation gene sequencing making it possible for clinical labs to create thousands of new tests. How many new tests? NextGxDx, an information technology company, says the nation’s clinical laboratories are introducing new m…
Might Lawsuits Come Next in Theranos Story?
By Robert Michel | From the Volume XXII, Number 16 – November 16, 2015 Issue
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…
Theranos, Capital Blue Sign Lab Test Agreement
By Joseph Burns | From the Volume XXII No. 10 – July 13, 2015 Issue
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…
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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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