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Amazon
New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings
CEO SUMMARY: Our second installment in this series describes an emerging new clas…
Amazon Now Interested in Home Testing Services
CEO SUMMARY: In the past year, internet retailing giant Amazon has built sizeable clinical laboratories in the United States and the United Kingdom. Now it has regulatory clearance to sell a molecular COVID-19 test to consumers for home collection. Comments made in the past month by…
Amazon Makes Big Play into Health, Diagnostics
CEO SUMMARY: Amazon is prepared to award $12 million in grants and is soliciting proposals for developing diagnostic technologies for detecting SARS-CoV-2 and other infectious diseases. This is the latest indication that the multi-billion-dollar enterprise would like to disrupt heal…
Amazon Sells COVID-19 Test Kit for At-Home Use by Consumers
QUIETLY AND WITHOUT MUCH ATTENTION, online retailing giant Amazon began to sell a COVID-19 molecular test to consumers for at-home testing. This is consistent with other actions Amazon has taken to generate revenue during the SARS-CoV-2 pandemic. …
Amazon Targets COVID-19 Testing in its New Lab-Building Venture
This is an excerpt of a 1,980-word article in the August 3, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent COVID-19 t…
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…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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