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FDA

Genetic Testing Continues to Grow in Volume and Complexity

This is an excerpt of a 1,333-word article in the July 26, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Getting paid for genetic testing continues to be a challenge. This is true for both payers and the…

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Artificial Intelligence Is Ready to Deliver for Labs

CEO SUMMARY: Artificial intelligence (AI) may be one of the most over-used terms to describe a host of different applications, software tools, and products. However, during the past year, some truly revolutionary digital tools are now in use by a small number of innovative clinical laboratories…

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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…

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New Twist: HHS Exerts Authority Over FDA on LDTs

CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…

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