Paweletz: Lung ca is increasingly a disease of targetable driver genes. Emergence of T790M-mut clones is inevitable #Tricon

3:27pm February 24th 2017 via Twitter Web Client

Paweletz: It is a 'tick-tock' cycle of innovation, biology, assays; lung ca is the 'poster child for personalized med' #Tricon

3:26pm February 24th 2017 via Twitter Web Client

Paweletz: They work with Pharma, CLIA dev, partner with biotech for assay dev/validation/licensing. #Tricon

3:25pm February 24th 2017 via Twitter Web Client

Cloud Paweletz (Dana Farber MA) Monitoring cancer through blood #Tricon

3:24pm February 24th 2017 via Twitter Web Client

Tam: Looking at 0.5% on @archerdx detection (AF from 0.35 to 1.18%) but 5/8 detected at 0.1% (0.1-0.27%) #Tricon

3:16pm February 24th 2017 via Twitter Web Client

Tam: Plans to use @archerdx molecular-tagged cfDNA technology to look at <1% #Tricon

3:12pm February 24th 2017 via Twitter Web Client

Tam: Titrated Acrometrix controls to 1%, was able to show sensitivity for most mutations. Error bkgd ~.5% #Tricon

3:08pm February 24th 2017 via Twitter Web Client

Tam: Needing to go to NGS, used @iontorrent for small input w/AmpliSeq. Complimentary comments about Ion Chef instrument #Tricon

3:07pm February 24th 2017 via Twitter Web Client

Tam: ddPCR cp to qPCR, shows greater sensitivity (not surprisingly) #Tricon

3:03pm February 24th 2017 via Twitter Web Client

Tam: Asssay sensitivity is directly proportional to amout of input; 20ng = 0.08%; 10ng at 0.17%. Data across multiple genes #Tricon

3:02pm February 24th 2017 via Twitter Web Client

Tam: ddCPR provides higher accuracy and sensitivity for quantification esp for FFPE. At 350ng input (10K copies) can detect to 0.01% #Tricon

3:00pm February 24th 2017 via Twitter Web Client

Tam: Shows longitudinal blood draw and imaging data for n=30 pediatric pts for cobas EGFR v2, ongoing trial #Tricon

2:57pm February 24th 2017 via Twitter Web Client

Tam: Has been responsible for bringing in new technologies; shows data from Bettegowda '14 regarding % by stage. #Tricon

2:55pm February 24th 2017 via Twitter Web Client

Rachel Tam (Genentech CA) Ultra-sensitive mutational analysis in cell-free DNA by digital PCR and NGS technologies #Tricon

2:51pm February 24th 2017 via Twitter Web Client

Dobrovic:dPCR is good, cheap and fast unlike this https://t.co/Uzau4FemWK and can recommend #Tricon

2:49pm February 24th 2017 via Twitter Web Client

Dobrovic: Word about digital PCR and this funny image https://t.co/Uzau4FemWK 'you can only pick 2 of 3', dPCR is good, cheap, and fast

2:48pm February 24th 2017 via Twitter Web Client

RT @GenomeNathan: Variants, shmariants! Let's ponder the mysteries of -genotypes- together, 10am Moscone room 309. #TriCon

1:02pm February 24th 2017 via Twitter Web Client

RT @jgreid: EK: We need to come away from race/ethnicity as discrete ideas, treat them like the continuum that they are genetically #AGBT17

5:46pm February 13th 2017 via Twitter Web Client

RT @TorontoGenomics: EK: Created an array - MEGA range - global screening array from Illumina. Yes...Arrays! See...they are still useful p…

5:34pm February 13th 2017 via Twitter Web Client

RT @NatureNews: Astronaut twin study results are in, work is some of the most detailed molecular profiling ever done: https://t.co/Ztnnxots…

3:13pm January 27th 2017 via Twitter Web Client

Walcoff: The volume of info w/in the medical community: a concern in public health. How to define risk w/vast amt of data? #PMWC17

8:00pm January 25th 2017 via Twitter Web Client

Heichman: As CDx comes to inf disease, may have a larger public health inpact. Want a high bar for custom antibiotics. #PMWC

7:58pm January 25th 2017 via Twitter Web Client

Walcoff: I've seen tremendous movement (from the FDA) in the past few years; what the challenges are from the things they propose #PMWC17

7:55pm January 25th 2017 via Twitter Web Client

Thomae: Points out that CLIA came out during the Reagan administration. Heichman: Still interest in practical considerations #PMWC17

7:54pm January 25th 2017 via Twitter Web Client

Walcoff: The final guidance is the "in or out of LDT's"; it is harder to get a guidance withdrawn. #PMWC17

7:51pm January 25th 2017 via Twitter Web Client

Walcoff: People at HHS w/IVD guidance. 'This is not binding' but it was treated that way. FDA may not finalize it. #PMWC17

7:50pm January 25th 2017 via Twitter Web Client

FDA holding off on final guidance? Thomae: Currently FDA policy, not heard anything to the contrary. Some drug co's may risk it. #PMWC17

7:48pm January 25th 2017 via Twitter Web Client

Walcoff: You are presumably getting more value with more markers; the gov't goal is to pay less. #PMWC17

7:40pm January 25th 2017 via Twitter Web Client

Thomae: Grail was named that way for a reason; it's going to be a lot of data, a lot of sequencing. Payors all sorting that out. #PMWC17

7:39pm January 25th 2017 via Twitter Web Client

Thomae: CUP is tricky too. And what about databases, knowledge bases? What is the intended use? Hard to explain, how specific. #PMWC17

7:38pm January 25th 2017 via Twitter Web Client

Q:Pan-cancer panels? Thomae: It's tricky; different markers have different significance in cancer. From FFPE to ctDNA, #PMWC17

7:38pm January 25th 2017 via Twitter Web Client

Thomae: An FDA clearance doesn't mean you get reimbursed; #PMWC17 Heichman: The disconnect can be bad - good test, poorly reimbursed.

7:36pm January 25th 2017 via Twitter Web Client

Walcoff: They did everything right on both sides (FDA, CMS) but the Preventative Services TF: have become more influential #PMWC17

7:34pm January 25th 2017 via Twitter Web Client

Thomae: Exact Sciences went down the path of both FDA and CMS reimbursement simultaneously, and did well as a result. #PMWC17

7:33pm January 25th 2017 via Twitter Web Client

Heichman: Lots of tests are complementary Dx - just not labeled that way. Sometimes related to disease rather than the drug. #PMWC17

7:29pm January 25th 2017 via Twitter Web Client

Thomae: An example would be Foundation Med - part of the process. Can be declared a success. #PMWC17

7:23pm January 25th 2017 via Twitter Web Client

Heichman: PD1 is considered a failure; a nightmare for everyone, no standardization. How not to do this. #PMWC17

7:20pm January 25th 2017 via Twitter Web Client

Heichman: They were approved, but not successful. HER2 is routine, widely adopted, effort to standardize. #PMWC17

7:20pm January 25th 2017 via Twitter Web Client

Q: Examples of success? Heichman: Two successful ones were Orphan Drug Act ones. Rare disease, zero tests in a year. #PMWC17

7:19pm January 25th 2017 via Twitter Web Client

Heichman: Expense of better drugs, better price with better performance; diagnostics do not enjoy those financials. #PMWC17

7:18pm January 25th 2017 via Twitter Web Client

Heichman: Coming to labs early in the design process; for a high-complexity lab, automation is off-label anyway. User needs first. #PMWC17

7:16pm January 25th 2017 via Twitter Web Client

Thomae: It's always the challenge in Dx - will the lab use it? Will they make their own? A product they actually want? #PMWC17

7:15pm January 25th 2017 via Twitter Web Client

Heichman: There's no balance between FDA-approved kit cost, to what the reimbursement is. Incentive is only desire for compliance. #PMWC17

7:14pm January 25th 2017 via Twitter Web Client

Heichman: Challenge is that a CDx can take a long time, the assay may not be the state-of-the-art. Decision made to go w/LDT instead #PMWC17

7:13pm January 25th 2017 via Twitter Web Client

Walcoff: Reimbursement challenges along with reg uncertainty; but still medicine needed. Ordering tests for a variety of reasons #PMWC17

7:13pm January 25th 2017 via Twitter Web Client

Thomae: Within Pharma world, balance between technology and the lowest risk. #PMWC17

7:10pm January 25th 2017 via Twitter Web Client

Walcoff: The commercial end-product is always the goal; commercial decisions around the drug drive decisions more than the assay. #PMWC17

7:10pm January 25th 2017 via Twitter Web Client

Thomae: There is a technology component as well; multiplexed tech, thresholds, LoD for FISH or IHC #PMWC17

7:09pm January 25th 2017 via Twitter Web Client