@DLApathologist profile picture
Dr. Dara @DLApathologist

Molecular and Surgical Pathologist. Opinions expressed are my own. I'm sorry, I cannot offer medical advice via Twitter.

Joined January 2015
  • Tweets 41
  • Following 14
  • Followers 55
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Important issue, glad there is healthy debate. #LCSM
T4: #LDTs have additional opportunities to promote #patient safety due to the professional judgment used at every stage. #LCSM
T4:The #NGS guidance suggests #FDA knows non-traditional regulatory pathways are essential to foster #innovation for dx testing. #LDT #LCSM
T4: Lab pros use the latest scientific information when developing #LDT services to inform your diagnosis and #treatment decisions. #LCSM
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T3: #LDTs are not like boxed and shipped #IVD test kits. They are medical service throughout the design, performance & interpretation. #LCSM
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T3: Precision medicine in patient care depends on using best & most relevant scientifically-verified information to modify a test. #LCSM
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T3: #LDTs are designed, developed, validated, performed, and interpreted all within the same lab by trained medical professionals. #LCSM
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T3 #LDTs within the scope of a board-certified lab professional practice and these professionals have a legal responsibility for them. #LCSM
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T3: Proposed framework will interfere with practice of medicine & impair access to critical testing & therapy for patients. #LCSM
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T2: #Clinical validity is established in the scientific literature most often before an #LDT service is offered. #LCSM
T2FDA approved test has had extensive testing, but that doesn’t make it better than an #LDT designed & used by a local with expertise. #LCSM
T2: Modernizing CLIA is the most efficient way to achieve uniformity, preserve innovation and access to testing for cancer patients #LCSM
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T2: #FDA can’t prevent all false positive and false negative results. #Patient safety is also in the hands of their physicians! #LCSM
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#LDT reports should always list the assay limitations to shows the characteristics of the test and what may be missing! #LCSM
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All of medicine has a subjective component. Some tests have a subjective component too. This is why experience counts #LCSM
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T1: Highly trained #healthcare professionals involved in every step, including design, validation, interpretation, of #LDT services #LCSM
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Clinical validity is about whether it is useful. Don't you want your doc deciding that?
T1: #LDTs are already extensively evaluated for #accuracy, among many other parameters. #LCSM
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T1: A lab that is CLIA certified or @Pathologists accredited means lab applies principles of validation to every #LDT they develop . #LCSM
I’m Dr. Dara Aisner, molecular pathology lab director at University of Colorado, joining my first-ever tweetchat. Important topic! #LCSM
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