Q:How much DNA into assay? Scudder: 2mL plasma, not quantitated #Tricon
2:32pm February 22nd 2017 via Hootsuite
Scudder: #Tricon AstraZeneca published AURA3 in '16 NEJM https://t.co/NVtpAAxQCT Erlotinib approved in summer '16, other approved later
2:31pm February 22nd 2017 via Hootsuite
Scudder: Osimertinib, clin utility of PPA L858R also 75%. NPA also 98%. Tissue neg, plasma pos, 'considered wrong, affecting stats' #Tricon
2:29pm February 22nd 2017 via Hootsuite
Scudder: Clin response: improved PFS from both plasma and tissue. EGFR+ in tissue and plasma, similar benefit #Tricon
2:28pm February 22nd 2017 via Hootsuite
Scudder: Agreement between tissue and plasma, PPA 76%, NPA 98%. #Tricon
Scudder: In the meantime their sample prep kit was approved. Detected 0.3% in wt background. PPA 87% for ex90del/L858R #Tricon
2:27pm February 22nd 2017 via Hootsuite
Scudder: Found untreated Stg IV recurrent NSCLC, FDA allowed it. 'Now even more complex'. Two clinical trials: clin and analytic #Tricon
2:26pm February 22nd 2017 via Hootsuite
Scudder: Clinical validation - 217 enrolled, 180 w/2mL of plasma, not enough for analytical studies. #Tricon
2:25pm February 22nd 2017 via Hootsuite
Scudder: Used contrived samples, diluting cell line DNA in healthy donor plasma; showed commutability, equiv results at LOD conc #Tricon
2:24pm February 22nd 2017 via Hootsuite
Scudder: FDA requested cancer plasma, not normal plasma for NSCLC. Est 32L of plasma (!) FDA 'were ultimately receptive' #Tricon
2:23pm February 22nd 2017 via Hootsuite
Scudder:Used allele-spec PCR tech, multiplexed for tissue. Did IUO erlotinib Ex19del L858R, UD-IVD; osimertinib, T790M US-IVD #Tricon
2:22pm February 22nd 2017 via Hootsuite
Scudder: #Tricon Clinical drug resp is ultimate indicator of how good the drug will be. ddPCR hard to multiplex https://t.co/c9n9L47iqb
2:21pm February 22nd 2017 via Hootsuite
Scudder: v2 was similar to the first one; 3-well test (too much info too fast). AURA2: NCT02094261, EGFR T790M+, first-line prog #Tricon
2:20pm February 22nd 2017 via Hootsuite
Scudder: erlotinib and osimertinib, a whole other level of complexity. (US-IVD most challenging) #Tricon
2:18pm February 22nd 2017 via Hootsuite
Scudder: Drives need for constructing contrived (synthetic) samples to evaluate test performance. Pharma interest to co-dev #Tricon
Scudder: Most had EGFR of <200 copies/mL (!) Had to work with IRB, ICF, HIPAA rules, population is ill. 40mL blood max #Tricon
2:17pm February 22nd 2017 via Hootsuite
Scudder: Prospective collection and time to screen; 'spent $2M just buying samples from vendors'. 1000 specimens, to find 80 w/muts #Tricon
2:16pm February 22nd 2017 via Hootsuite
Scudder: In '13 - no validated methods, no int'l stds, EGFR Mut Test v2 det 42 mutations under dev. Had to validate LOD etc #Tricon
Scudder: #Tricon Reviewed results from '14 ref https://t.co/UW5k4AjEXi activating mutations persist in plasma
2:15pm February 22nd 2017 via Hootsuite
Scudder: #Tricon Clearing ct EGFR DNA, increased OS and PFS. Predictive for survival. Denmark study next https://t.co/65piOUdh8S
2:12pm February 22nd 2017 via Hootsuite
Scudder: FASTACT-2 PhIII study was Erlotinib and chemo, and EGFR +/- status comparing tumor to plasma #Tricon
2:11pm February 22nd 2017 via Hootsuite
Scudder: 166bp or 140bp, half-life of 1.5h. Naked DNA lasts only a few minutes. Shows long list of genes https://t.co/V6K3aYQIvQ #Tricon
2:10pm February 22nd 2017 via Hootsuite
Scudder: Platelets are 'basically a large exosome'; CTCs, ctDNA, small vesicles. Most ctDNA is histone-assoc'd. #Tricon
2:08pm February 22nd 2017 via Hootsuite
Scudder: Challenges 'could be significant' at times. Drawing from https://t.co/DZUMLgjoY5 cancer cells are constantly growing/dying #Tricon
2:07pm February 22nd 2017 via Hootsuite
Sid Scudder (Roche Molecular CA) Liquid biopsy for EGFR, the cobas EGFR Mutation Test v2 the long and winding road #Tricon
2:05pm February 22nd 2017 via Hootsuite
Luthra: Concludes by introducing liquid biopsy as an atlernative: CTC, exosomes, ctDNA and ctRNA #Tricon
Luthra: 10% insufficient tissue; sampling error and bias '12 NEJM https://t.co/hcPJSmLBE2 63% missed due to sampling heterogeneity #Tricon
2:03pm February 22nd 2017 via Hootsuite
Raja Luthra (MD Anderson TX) Tumor genotyping is the current Gold Standards - TAT typically 4-5d, but add'l weeks to get tissues #Tricon
2:01pm February 22nd 2017 via Hootsuite
Bischoff: Growing evidence demonstrating surragacy to tumor tissue biopsy; repeatable throughout Rx #Tricon
12:23pm February 22nd 2017 via Hootsuite
Bischoff: Liquid biopsy is turned to when tissue is not available or insufficient. Early evidence of resistance, recurrance. #Tricon
12:22pm February 22nd 2017 via Hootsuite
Bischoff: FFPE 20-25% failure in NGS; FISH 10-15% biomarker inconclusive; TILs have complex infiltration #Tricon
12:21pm February 22nd 2017 via Hootsuite
Bischoff: Points out FFPE tissue has challenges in both pre-analytical and heterogeneity in analysis #Tricon
12:20pm February 22nd 2017 via Hootsuite
Farideh Bischoff (Chief Clin Dev Officer) Digital cell sorting and recovery - standardization of sample preparation #tricon
12:18pm February 22nd 2017 via Hootsuite
Ferree: Down to PD-1/PD_L1; Lag3, TIM3, IDO Blockade; MDSC targeting Carbo/Taxol; Treg; Wnt inh, PI3K inh; HDAC inh; CTLA-4 inh #Tricon
12:16pm February 22nd 2017 via Hootsuite
Ferree: Shows slide of their vision for a universal immune-oncology assay - T-cell inflamed ("hot") and "cold" branches #Tricon
12:15pm February 22nd 2017 via Hootsuite
Ferree: Pathway, Immune profiling, and Progression panels cover the Hanahan hallmarks of cancer #Tricon
12:13pm February 22nd 2017 via Hootsuite
Ferree: Current testing paradigm of one test, one drug, wasteful. Core research use panel: PanCancer, 770-plx covering all hallmarks #Tricon
12:12pm February 22nd 2017 via Hootsuite
Sean Ferree (VP Development NanoString) Discovering again and again, how complex cancer biology is. #Tricon
12:11pm February 22nd 2017 via Hootsuite
Garlick: Products for solid sumor @SeraCare with SNVs, Indels, RNA fusions, coming soon - CNVs. ctDNA w/NIST; inh disease #Tricon
12:09pm February 22nd 2017 via Hootsuite
Garlick: NGS Dx has many QC checkpoints, and require a 'truth set'. Fernandes pointed out pre-analytical and bioinf variables #Tricon
12:08pm February 22nd 2017 via Hootsuite
Garlick: NIPS error rate is 3.8% (!) for published data https://t.co/ACQnNUR2yW #Tricon
12:06pm February 22nd 2017 via Hootsuite
Garlick: Need proficiency testing, modernized CLIA. The broad idea, sharing of data. Rehm rev '16: https://t.co/3hpjEEHzvE #Tricon
12:05pm February 22nd 2017 via Hootsuite
Garlick: Points out that goals like the Cancer Moonshot need faster and more accurate disease genotyping. Reporting: need truth sets #Tricon
12:03pm February 22nd 2017 via Hootsuite
Russell Garlick (CSO SeraCare) Advancing Next Generation Sequencing Technology #Tricon
12:02pm February 22nd 2017 via Hootsuite
Vossenaar: One user in Milan: Went from 3-4 weeks TAT, to a single day. Many pts in Italy have to travel to see oncologists #Tricon
12:00pm February 22nd 2017 via Hootsuite
Vossenaar: Thus Idylla NB- I blogged about the system Nov '15 here: https://t.co/qoeumvxLmh #Tricon
11:59am February 22nd 2017 via Hootsuite
Vossenaar: AstraZeneca compared 12 methods for KRAS - from RT-qPCR, MALDI-TOF, NGS< ddPCR, and Sanger #Tricon
11:58am February 22nd 2017 via Hootsuite
Vossenaar: 1/4 pts start of 1st line Rx are before test results, including insufficient tissue. Shows chart comparing methods #Tricon
Erik Vossenaar (VP BioCartis): Molecular medicine for every patient #Tricon
11:55am February 22nd 2017 via Hootsuite
Ferrara: Will oncology informatics drive providers to accept more risk for oncology care? #Tricon
11:53am February 22nd 2017 via Hootsuite
