TAG:
COVID-19 tests
New Clinical Lab Opens on March 23 and Prospers
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
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
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
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…
Understanding COVID-19’s Changes to Lab Industry
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
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
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…
Covid-19 Pandemic May Be Creating New IVD Winners and Losers
WITH THE PANDEMIC NOW IN ITS NINTH MONTH, in vitro diagnostics (IVD) company executives and industry consultants recognize the market for clinical laboratory instruments, tests, and products is changing in fundamental ways. “Evidence accumulates that the pandemic is helping create …
Labs Adjust to COVID-19 as a Regular Part of Care
ONE INTERESTING NEW DEVELOPMENT NOT REPORTED MUCH BY THE NATIONAL MEDIA is that the daily number of new COVID-19 cases in the United States has declined steadily in the past month. It is too early to understand the implications of this development, but clinical lab administrators and pathologists…
Wisconsin Lab Network Feeds Valuable Data to State Health Lab
CEO SUMMARY: From the earliest days of the COVID-19 pandemic, the 138-member Wisconsin Clinical Laboratory Network has reported to the state health lab the number of COVID-19 tests, the number of positive results, as well as other data that includes data on lab testing supplies and ca…
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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