Tsongalis: We keep pushing as what's not actionable today may be so next month or year. Remining is impt, accurate all over. #PMWC17

5:21pm January 24th 2017 via Twitter Web Client

Not aligned reads? Aisner: They BLAST all reads, and often soft-clipping was too aggressive. Indels of particular interest #PMWC17

5:20pm January 24th 2017 via Twitter Web Client

(Jim): Cancer moonshot - feels there has made some progress. Asiner: In CO, instrumentation works differently at altitude. #PMWC17

5:18pm January 24th 2017 via Twitter Web Client

Aisner: CAP attempted to do this, but due to scarcity of materials, didn't get going due to lack of participation #PMWC17

5:15pm January 24th 2017 via Twitter Web Client

Q: Datasharing to give? Why for free? Tsongalis: We do this now, on an individual basis. #PMWC17

5:14pm January 24th 2017 via Twitter Web Client

Tsongalis: The big thing is clinical usefulness. <100 genes w/clinically actionable variants. But he's cautious. #PMWC17

5:13pm January 24th 2017 via Twitter Web Client

Aisner: Data is forthcoming, but guidance would be invaluable for handling for ctDNA. #PMWC17

5:12pm January 24th 2017 via Twitter Web Client

Aisner: Pre-analytic variables more complex for ctDNA. Not a lot of understanding how to handle. Time? Temp? Tube? Spins? #PMWC17

5:11pm January 24th 2017 via Twitter Web Client

Garlick: Development of ctDNA; $340M invested; advice on taking new technology into your labs and to patients? #PMWC17

5:10pm January 24th 2017 via Twitter Web Client

Tsongalis: The complexity of the question (regarding panels, tests) not answerable by a repository #PMWC17

5:09pm January 24th 2017 via Twitter Web Client

Tsongalis: Feels inspection needs to be tightened, can be improved. Need to publish validation as often as they can #PMWC17

5:07pm January 24th 2017 via Twitter Web Client

Garlick: Outgoing FDA commissioner and transparency? Aisner: You get samples via CAP, or other sources. Then PT to show it. #PMWC17

5:06pm January 24th 2017 via Twitter Web Client

Tsongalis: Very difficult to find people with NGS experience - 'the biggest challenge of my career'. Some techs - can't get trained. #PMWC17

5:03pm January 24th 2017 via Twitter Web Client

Tsongalis: Need LOD for various types of mutations; different opinions, can't skimp on. Impacts life-extending Rx #PMWC17

5:02pm January 24th 2017 via Twitter Web Client

Tsongalis: How about validating a whole exome? How many samples would you need for every mutation? #PMWC17

5:01pm January 24th 2017 via Twitter Web Client

Tsongalis: A lucky catch, by sharing samples. Specimens for eval, validation, proficiency needed but hard to get. #PMWC17

5:01pm January 24th 2017 via Twitter Web Client

Tsongalis: Weekly basis 'we look at metrics that we never thought we'd have to look at before' #PMWC17

5:00pm January 24th 2017 via Twitter Web Client

Tsongalis: Went back, looked at their whole process. 15% EGFR del in '13 missed. Updated, revalidation, now confirming for 3 mos #PMWC17

4:59pm January 24th 2017 via Twitter Web Client

Tsongalis: Shared samples with other lab that was also validating. Got the unwanted call "sample #7 had an exon 19 del" #PMWC17

4:58pm January 24th 2017 via Twitter Web Client

Tsongalis: For their validation - what caught them was their data analysis. #PMWC17

4:57pm January 24th 2017 via Twitter Web Client

Tsongalis: If you can't afford to validate a test properly, perhaps you shouldn't be running it. #PMWC17

4:56pm January 24th 2017 via Twitter Web Client

Tsongalis: Their method called CGAT - a close look at data analytics. Just b/c you have an instrument and kit, you still need QC #PMWC17

4:55pm January 24th 2017 via Twitter Web Client

Greg Tsongalis (Dartmouth Hitchcock) QC: Where the rubber meets the road #PMWC17

4:53pm January 24th 2017 via Twitter Web Client

Aisner: Showed poor quality FFPE QC, many pages of artifacts, still picked up EGFR exon 19 del #PMWC17

4:52pm January 24th 2017 via Twitter Web Client

Aisner: NGS metrics: % mapped. What happened to non-mapped? Amt of soft clipping? On-board QC (PhiX) #PMWC17

4:49pm January 24th 2017 via Twitter Web Client

Aisner: Flexibility important; what the quality is of the input - fluorometric, microgel, real-time PCR. 'None is foolproof' #PMWC17

4:48pm January 24th 2017 via Twitter Web Client

Aisner: Need to look at matrix effects - components of human tisue. Fixatives, processing. Metrics to establish: extracted nucl acid #PMWC17

4:46pm January 24th 2017 via Twitter Web Client

Aisner: Sharing a subset of slides presented at the FDA - webcast here https://t.co/LcTeIL5Q6c #PMWC17

4:45pm January 24th 2017 via Twitter Web Client

Dana Aisner (Univ CO SOM): Confronting and mitigating pre-analytic variability #PMWC17

4:43pm January 24th 2017 via Twitter Web Client

Garlick: Working with NIST and EDRN for ctDNA with reference materials #PMWC17

4:39pm January 24th 2017 via Hootsuite

Garlick: SeraCare is bringing products to FDA; de-novo application of 37 ver's at 10% VAF #PMWC17

4:37pm January 24th 2017 via Hootsuite

Garlick: Millions of NIPT samples/year yet no PT program in place. Tapestry network - 'Oncologists concerned CDx about lab results' #PMWC17

4:35pm January 24th 2017 via Hootsuite

Garlick: 2/6 labs report incorrect cardiomyopathy results (Vrijenhoek in EJHG) #PMWC17

4:34pm January 24th 2017 via Hootsuite

Russell Garlick (CSO SeraCare) Achieving Accurate NGS Test Results #PMWC17 NIPS error rate is 3.8%

4:33pm January 24th 2017 via Hootsuite

Q: Scene in China? Beresford: Feel that it'll become std of care sooner in China than here. #PMWC17

3:18pm January 24th 2017 via Hootsuite

Beresford: Shortening time from Dx to Rx '16 ref https://t.co/Pge68IaxIf #PMWC17

3:15pm January 24th 2017 via Hootsuite

Beresford: "actionable results in 72h for pts with NSCLC" - shortening time from Dx to Rx for NSCLC. Usually 3-6w for tissue testing #PMWC17

3:13pm January 24th 2017 via Hootsuite

Beresford: genestrat test now has actionable muts (EGFR, ALK, ROS, RET), also T790M result; reflex to verstrat for Pt-Rx or TKI #PMWC17

3:12pm January 24th 2017 via Hootsuite

Beresford: Prognostic, based upon 8 parameters. Describes advanced-NSCLC for their VeriStat, covered by Medicare, 220M pt coverage #PMWC17

3:11pm January 24th 2017 via Hootsuite

Beresford: Estimated 150K publications for biomarkers. They have a MALDI-ToF MS test called VeriStrat, with spectra #PMWC17

3:07pm January 24th 2017 via Hootsuite

Paul Beresford (Biodesix) Discovering, developing, validating and commercializing liquid biopsy tests in oncology #PMWC17

3:06pm January 24th 2017 via Hootsuite

Otto: Critical to look beyond ctDNA - CTCs, tissues, proteins, RNA. #PMWC17

3:03pm January 24th 2017 via Hootsuite

Otto: Need to demonstrate contam. control, detection. Precision for intra- and inter-run. Also concordance w/orthogonal validation #PMWC17

3:02pm January 24th 2017 via Hootsuite

Otto: Claim 50% conversion efficiency for >5000x sequencing. Analytic validation - use mix of cell lines, synthetic spike-ins #PMWC17

3:01pm January 24th 2017 via Hootsuite

Otto: They've built kits to maximize stability. Also: how to interpret negative results? 2w stability in their kits. #PMWC17

3:00pm January 24th 2017 via Hootsuite

Otto: Clinical challenge: no path review, thus need for low AF measurement. Need SNV, indel, CNA, fusions. Limited smpl stablity #PMWC17

2:57pm January 24th 2017 via Hootsuite

Otto: Yield, dynamic range is highly variable. ctDNA is indirect interrogation. Potential insight into 'systemic' disease (resist) #PMWC17

2:55pm January 24th 2017 via Hootsuite

Geoff Otto (Foundation Medicine) Development and analytic validation of a ctDNA genomic profiling assay #PMWC17

2:53pm January 24th 2017 via Hootsuite

Pralahad: Developed 200 documents for CAP, down to single-cell level. Collab w/Genomic Health, also participating in Moonshot #PMWC17

2:52pm January 24th 2017 via Hootsuite

Pralahad: Looking at AR-V7, published JAMA '16 https://t.co/uaMeBs5vf2 want to optimize process from phlebotomy to result #PMWC17

2:50pm January 24th 2017 via Hootsuite