TAG:
covid-19 testing
Lab Leaders Say COVID-19 Tests Needed in 2021
By R. Lewis Dark | From the Volume XXVII, No. 15 – October 26, 2020 Issue
How long into the future will clinical laboratories need to offer COVID-19 tests on a large scale? That is the number one question confronting labs in every region of the United States. Last week, three nationally-known lab CEOs answered that question during the general session of the Virtual E…
Medicare to Cut Payment for COVID Tests Starting Jan. 1
By Robert Michel | From the Volume XXVII, No. 15 – October 26, 2020 Issue
CEO SUMMARY: Starting Jan. 1, CMS will lower the COVID-19 test payment to $75 when labs with “high-throughput systems” report a COVID-19 test result after 48 hours. This is the federal government working at cross purposes, since other federal agencies are diverting COVID-19 testin…
New Clinical Lab Opens on March 23 and Prospers
By Robert Michel | From the Volume XXVII, No. 15 – October 26, 2020 Issue
CEO SUMMARY: Timing is everything when launching a new clinical laboratory business. The March 23 grand opening of Incyte Pathology’s clinical lab came in the midst of the collapse of daily routine specimen referrals. But once the lab was operational, Incyte had the capability, the …
$481 Mil Federal COVID Contract Awarded to Young IVD Company
By Robert Michel | From the Volume XXVII, No. 15 – October 26, 2020 Issue
IN THEIR FIGHT AGAINST THE PANDEMIC, federal officials are boosting the fortunes of some little-known or emerging in vitro diagnostics (IVD) companies. One example is the recent award of a $481 million COVID-19 test contract to Cue Health Inc., of San Diego. Earlie…
October 26, 2020 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVII, No. 15 – October 26, 2020 Issue
In Houston, an 18-year-old high school student started a mobile laboratory company to provide COVID-19 tests to home-bound patients. As the youngest emergency medical technician in Texas, Taft Foley, III, saw the need for this service. Texas Mobile Medical Labs is the name of his company a…
High-Complexity Mobile Labs for COVID-19 Testing
By Robert Michel | From the Volume XXVII, No. 14 – October 5, 2020 Issue
CEO SUMMARY: Demand for high-complexity mobile coronavirus testing facilities is high, according to the CEO of a start-up company building 25 clinical labs in mobile trailers that can do hundreds of tests per eight-hour day. Employers, schools, event organizers, and other entities all…
Coming Soon: a Different Clinical Lab Industry
By R. Lewis Dark | From the Volume XXVII No. 13 – September 14, 2020 Issue
“Keep your eye on the ball” is an idiom that originated with baseball. The idea is that every player on the field should, at all times, know where the ball is so that they can be ready to do their job when the ball comes their way. This is excellent advice for clinical lab administrators and…
Understanding COVID-19’s Changes to Lab Industry
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
CEO SUMMARY: With the SARS-CoV-2 pandemic about to enter its eighth month in the United States, it remains difficult to predict whether the pandemic will strengthen with the fall influenza season or steadily diminish. What is clear to most pathologists and clinical laboratory executiv…
Texas Company Operates 400 COVID-Collection Sites
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
CEO SUMMARY: In April, the federal Department of Health and Human Services contracted with eTrueNorth to operate COVID drive-through specimen-collection sites under the Community-Based Testing Sites program. The drive-through sites are an extension of non-COVID testing the company has …
New York Firm to Build CLIA Labs in Shipping Containers
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
CEO SUMMARY: In many respects, the COVID-19 pandemic is like a gold rush for entrepreneurs. Federal and state governments, colleges, employers, school districts, and other entities need COVID-19 tests and tens of billions of dollars are available to pay for such tests. This modern gol…
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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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