Top Tweets for #labdevelopedtests
Big shift in #diagnostics policy!
Federal judge vacated @US_FDA's rule to regulate #LabDevelopedTests #LDT, calling it #regulation overreach
Big win for #labs, clinical #innovation, & #medtech community
#FDA #healthtech #precisionmedicine @ASCP_Chicago
https://t.co/gzroVfVjUq
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Preview insights from our latest report βThe Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028.β
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https://t.co/CrYAnJ0x1l
#LDTs #LabDevelopedTests
Whatβs the recent buzz about laboratory-developed tests (LDT)? Visit our new topic to learn more about the impending FDA rule, how we got here, and how it may change pathology and lab practice: https://t.co/MxB5sfE3TQ.
#PathTwitter #PathologyOutlines #FDA #LDT #LabDevelopedTests
Very very interesting post on Emerging #D2C Models in #LabDiagnostics space. #LabDevelopedTests will surely pose a big Conflict of Interest.
This is what I always talk about , the CoI in these business models . Who will bell the cat ?
https://t.co/ckDISIUKep
2/
In 1976 the #FDA waived all regulatory requirements for a small number of #InVitroDiagnostic tests manufactured and analyzed all in the same lab. These #tests, known as #LabDevelopedTests (#LDTs), were considered low risk then as they were mainly used "in house" by hospitals
#LabDevelopedTests are used most frequently in #MolecularDiagnostics, which includes #genetictesting.
Applications include #oncology and inherited #diseases, but there's widespread use in #toxicology, blood coagulation, etc., reports @KaloramaInfo.
https://t.co/LgKhF3LwL5
Revival of Valid Act Draws Mixed Response: https://t.co/mEO6jLJnVM. Laboratory developed test regulations are discussed in Kalorama's report: Clinical Laboratory Services Market: https://t.co/Td981FM4z5 #LabDevelopedTests #ClinicalLaboratory
Regulation of #LabDevelopedTests has been a source of controversy among the #FDA. Read more: http://t.co/1VrDbF0xlo
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