TAG:
COVID-19
DOJ Says Georgia Man Got Kickbacks for COVID-19 Tests
By Joseph Burns | From the Volume XXVII No. 6 – April 20, 2020 Issue
JUST WEEKS AFTER THE FIRST CASES OF SARS-CoV-2 appeared in the United States, federal prosecutors filed criminal charges in a COVID-19 lab test fraud scheme. Erik Santos, 49, of Braselton, Ga., was charged with conspiracy to defraud federal and private healthcare programs by submitting fraudule…
Chicago Lab Launches LDT, Finds 20% Positive
By Joseph Burns | From the Volume XXVII No. 6 – April 20, 2020 Issue
CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its ow…
APRIL 20, 2020 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVII No. 6 – April 20, 2020 Issue
Not only did the outbreak of SARS-CoV-2 in the United States show how unprepared the nation was for an event like this, but it exposed numerous problems and weaknesses in the federal agencies tasked with protecting the health and safety of the American public. One high-profile failure hap…
Regulators Acted Slowly as Labs Developed Tests for Coronavirus
By Joseph Burns | From the Volume XXVII No. 5 – March 30, 2020 Issue
WHEN THE FIRST DEATHS FROM THE NOVEL CORONAVIRUS were reported in Seattle beginning on Feb. 29, Helen Chu, MD, MPH, took notice. An infectious disease expert at the University of Washington School of Medicine, Chu is a director with the Seattle Flu Study. Since…
In New York, Lab Offers Mobile Virus Sample Collections
By Joseph Burns | From the Volume XXVII No. 5 – March 30, 2020 Issue
CEO SUMMARY: To allow patients and physicians to order at-home specimen collections of the novel coronavirus, Northwell Labs trained its 12-member mobile phlebotomy service in the procedures needed to collect samples using nasopharyngeal (NP) swabs. Since training occurred in …
At the Epicenter, Northwell’s COVID-19 Lab Data Adds Value
By Joseph Burns | From the Volume XXVII No. 5 – March 30, 2020 Issue
This is an excerpt of a 3,210-word article in the March 30, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: This intelligence briefing provides a valuable look inside a …
Labs in Italy Moved Fast to Develop COVID-19 Tests
By Robert Michel | From the Volume XXVII No. 5 – March 30, 2020 Issue
Part One in a Series ITALY HAS ONE OF THE WORLD’S SEVEREST OUTBREAKS OF COVID-19 INFECTIONS, based on the number of cases and the mortality rate. In response, clinical laboratories there moved quickly to launch laboratory-developed tests and to increase the volume of COVID-19…
Drive-Up COVID-19 Test Site Launched in 3 Days
By Joseph Burns | From the Volume XXVII No. 5 – March 30, 2020 Issue
CEO SUMMARY: After seeing the largest cluster of confirmed coronavirus infections in one location, New York State took emergency measures “to attack the hotspot at its source.” The state opened a drive-through specimen-collection site offering free testing without an appoi…
Providers Get Creative as FDA Clears More IVD Firms’ Tests
By Joseph Burns | From the Volume XXVII No. 5 – March 30, 2020 Issue
CEO SUMMARY: Clinical and molecular test laboratories, hospitals, public health agencies, and other providers are taking unusual measures to expand the number of tests available to identify the spread of the new coronavirus. When a hospital needed funding to buy test kits for …
This Coronavirus Outbreak Will Change Lab Industry
By Robert Michel | From the Volume XXVII No. 5 – March 30, 2020 Issue
CEO SUMMARY: COVID-19 is causing a level of global disruption not seen since the influenza outbreak of 1918. This new infectious disease exposes flaws in the strategies and planning of public health officials and governments in the United States and abroad. In this country…
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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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