TAG:
clinical lab
UHC Issues Details about How Labs Register Tests
CEO SUMMARY: As of January 1, UnitedHealthcare will require all clinical laboratories and anatomic pathology groups to register every type of test before labs can bill for those tests. Not only is the COVID-19 pandemic disrupting normal activity, but the administrative burden UHC is i…
Amazon Building Labs to Do COVID-19 Testing
CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent lab-testing venture for employees could be a significant concern given that the e-commerce company could disrupt the clinical lab business nationwide. The online retail giant has long had an interest in medic…
Employers, Others Looking to Build New Clinical Labs
CEO SUMMARY: Employers, universities, municipalities, and other large organizations are interested in building their own clinical laboratories. In addition, entrepreneurs—many with no prior experience in laboratory medicine—want to make money providing COVID-19 testing. Many of th…
In Just 13 Days, Lab Buys, Validates & Uses Analyzer
CEO SUMMARY: In response to the nationwide outbreak of SARS-CoV-2, clinical labs are introducing new analyzers whenever possible to boost testing capacity. Pre-pandemic, buying and installing new instruments could take at least two months, and that timeline can go longer now. But beca…
IVD Firms Report Boom in Sales of COVID-19 Instruments, Tests
Because of the COVID-19 pandemic, second quarter earnings reports were a good news/bad news situation for most of the nation’s major in vitro diagnostic (IVD) companies. The good news was that demand for COVID-19 tests meant increased sales and revenues for IVD firms selling those…
Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?
This is an excerpt of a 1,420-word article in the July 13, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnos…
COVID-19 Pooled Testing: Good for Labs? Not IVDs?
CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number of standard tests for SARS-CoV-2, this testing method would cut lab spending on tests and testing supplie…
Officials Differ on Value of COVID-19 Pooled Testing
CEO SUMMARY: Some experts on testing strategies support pooled testing because this method may support reopening by schools and businesses and thus bring the economy back. But other experts have raised questions about this strategy. Rules from the federal Centers for Medicare …
Why Local Labs Deserve More COVID-19 Supplies
CEO SUMMARY: As government officials and IVD firms divert the lion’s share of COVID-19 tests to a handful of billion-dollar labs, in thousands of hospitals across the nation COVID-19 patients languish days longer before discharge because their hospital lab must send COVID-19 tests t…
Government Officials Intensify Broad Chaos In Clinical Lab Supply Chain
CEO SUMMARY: Clinical labs throughout the United States are ready to meet the challenges of the COVID-19 pandemic. At the same time, there is widespread recognition that many barriers to increasing labs’ COVID-19 testing capacity are caused by the inappropriate actions of government…
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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