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

T3: #LDTs are not like boxed and shipped #IVD test kits. They are medical service throughout the design, performance & interpretation. #LCSM

T3: Precision medicine in patient care depends on using best & most relevant scientifically-verified information to modify a test. #LCSM

T3: #LDTs are designed, developed, validated, performed, and interpreted all within the same lab by trained medical professionals. #LCSM

T3 #LDTs within the scope of a board-certified lab professional practice and these professionals have a legal responsibility for them. #LCSM

T3: Proposed framework will interfere with practice of medicine & impair access to critical testing & therapy for patients. #LCSM

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

T2: #FDA can’t prevent all false positive and false negative results. #Patient safety is also in the hands of their physicians! #LCSM

#LDT reports should always list the assay limitations to shows the characteristics of the test and what may be missing! #LCSM

All of medicine has a subjective component. Some tests have a subjective component too. This is why experience counts #LCSM

T1: Highly trained #healthcare professionals involved in every step, including design, validation, interpretation, of #LDT services #LCSM

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

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