Dr. Dara

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

[Dr. Dara @DLApathologist]

Important issue, glad there is healthy debate. #LCSM

[Dr. Dara @DLApathologist]

T4: #LDTs have additional opportunities to promote #patient safety due to the professional judgment used at every stage. #LCSM

[Dr. Dara @DLApathologist]

T4:The #NGS guidance suggests #FDA knows non-traditional regulatory pathways are essential to foster #innovation for dx testing. #LDT #LCSM

[Dr. Dara @DLApathologist]

@lauramkoontz @eyoste @JFreemanDaily So then they aren't about clinical validity, then if new muts are OK to report? #LCSM

[Dr. Dara @DLApathologist]

@JackWestMD Agree improving stds is good for everyone.FDA process will be slow&costly. Updates to CLIA use existing infrastructure #LCSM

[Dr. Dara @DLApathologist]

T4: Lab pros use the latest scientific information when developing #LDT services to inform your diagnosis and #treatment decisions. #LCSM

[Dr. Dara @DLApathologist]

@ryanbryan t @LungCancerFaces FDA approved tests don't even allow for interpretation - even when they are false pos or neg #LCSM

[Dr. Dara @DLApathologist]

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

[Dr. Dara @DLApathologist]

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

[Dr. Dara @DLApathologist]

@JackWestMD The regs may be well intentioned but will sweep up the good with the bad #LCSM

[Dr. Dara @DLApathologist]

@ryanbryan @JackWestMD That's exactly where FDA regs will get in the way of innovation #LCSM

[Dr. Dara @DLApathologist]

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

[Dr. Dara @DLApathologist]

@JackWestMD The fact that I and others put together these innovations is the practice of laboratory medicine #LCSM

[Dr. Dara @DLApathologist]

@JackWestMD Example: I would have to stop doing EGFR testing on cytology specimens, meaning lung ca pts would need more biopsies #LCSM

[Dr. Dara @DLApathologist]

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

[Dr. Dara @DLApathologist]

@JackWestMD Example: I would have to stop offering my BRAF test, which detects more patients eligible for tx than the FDA test #LCSM

[Dr. Dara @DLApathologist]

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

[Dr. Dara @DLApathologist]

@LungCancerFaces Agree completely. The ability to offer LDTs is what helps us drive the science and therapy #LCSM

[Dr. Dara @DLApathologist]

@johnpharmd Agree. Which means less innovation. Which means less possibility of life altering therapy #LCSM

[Dr. Dara @DLApathologist]

@JackWestMD If you only have enough material for one test, don't you want more than one answer? Maybe not everything, but >1? #LCSM