Stavis: Quantitiave measurements, with uncertainty; wants to make it routine and extensible to methylation, and mutation #NGDx16
3:44pm August 24th 2016 via Hootsuite
Stavis: Comes from 'Center for nanoscale science ant technology' at NIST; has a method of measuring size distribution #NGDx16
Sam Stavis (NIST) Optimal optical single-molecule fluorescence of ctDNA #NGDx16
3:43pm August 24th 2016 via Hootsuite
Plenty of room for tech development for single-molecule seq #NGDx16 https://t.co/94b1qJ7Nnt
3:42pm August 24th 2016 via Hootsuite
Roschewski: Data shows ctDNA corr to tumor load. Currently uses for surveillance mon for high-risk (needs to show clin util) #NGDx16
3:37pm August 24th 2016 via Hootsuite
Roschewski: They are detecting ctDNA encoding VDJ. Early progression '15 Lancet Oncol https://t.co/D0ELOev5ia #NGDx16
3:26pm August 24th 2016 via Hootsuite
Roschewski: Using Ig receptor sequencing, with Adaptive biotechnologies, to ID and quantify 'clonotypes' #NGDx16
3:21pm August 24th 2016 via Hootsuite
Roschewski: Liquid biopsy - capturing genetic info; 20% asymptomatic in surveillance. #NGDx16
3:17pm August 24th 2016 via Hootsuite
Roschewski: DLBCL is a curable condition; goal is to improve cure rate. Surveillance (std is CT Scans); interim, ID trtmt failure #NGDx16
3:14pm August 24th 2016 via Hootsuite
Mark Roschewski (NCI) Circulating tumor DNA in diffuse large B-cell lymphoma #NGDx16
3:13pm August 24th 2016 via Hootsuite
Hoon: Shows concordance studies between cfDNA and paired tumor analyses in StgIII ptsrange from 50% to 100% (Guardant Health data) #NGDx16
3:03pm August 24th 2016 via Hootsuite
Hoon: Showing data on melanoma monitoring by patient by cfDNA and LDG for StgIII and StgIV patients, correlation #NGDx16
3:01pm August 24th 2016 via Hootsuite
RT @h2so4hurts: Charles Chiu, UCSF: @nanopore to detect zika titer of 100/mL 12.9 minutes with minion. Sample prep still an issue #NGDx16
2:55pm August 24th 2016 via Hootsuite
Hoon: No question, informatics is critical. CNVs, amplifications, indels, SVs all important. #NGDx16
2:53pm August 24th 2016 via Hootsuite
Hoon: 900x coverage in their assay. Now pushing from 10mL down to 1.5mL, due to clinical trial limitations #NGDx16
2:50pm August 24th 2016 via Hootsuite
Hoon:Makes the point that there are many types of ctDNA. LOH, mutation, CNV, CpG hypermethylation, DNA integrity #NGDx16
2:48pm August 24th 2016 via Hootsuite
Dave SB Hoon (John Wayne Cancer) Multipanel MPS cfDNA in monitoring cutaneous melanoma progression #NGDx16
2:47pm August 24th 2016 via Hootsuite
Lee: This test was one-test, one-drug. Moving onto panels: multiple variants, different genes, multiple indications and drugs #NGDx16
2:40pm August 24th 2016 via Hootsuite
Lee: Perf. for clinical specimens was established; clinical specimens were limiting and contrived samples used in some studies #NGDx16
2:39pm August 24th 2016 via Hootsuite
Lee: Clinical bridging study: PFS w/muts in plasma was 8.3mo vs 4.6mo (K-M curves). #NGDx16
2:36pm August 24th 2016 via Hootsuite
Lee: ENSURE PhIII study of erlotinib vs cisplatin w/gemcitabine for 1st-line IIIb/IV NSCLC. 217 FFPET, 180 plasma #NGDx16
2:35pm August 24th 2016 via Hootsuite
Lee: Plasma volumes 'from pivotal clinical study were lacking' so used as many as 400 samples from alternative study #NGDx16
2:33pm August 24th 2016 via Hootsuite
Lee: Contrived - sheared cell-line DNA spike-ins to healthy plasma. For comparator method, used NGS-method. #NGDx16
2:32pm August 24th 2016 via Hootsuite
Lee: For add'l mutations, not established. Did comparator method validation; contrived sample commutability #NGDx16
2:30pm August 24th 2016 via Hootsuite
Lee:Test was previously approved in '13. TARCEVA (erlotinib) for Exon 19 del, L858R in EGFR from both FFPET and Plasma #NGDx16
2:29pm August 24th 2016 via Hootsuite
Lee: Will use Roche's recent test approval of cobas EGFR Mut Test v2; approved for NSCLC, approved June 1 '16 for erlotinib Rx #NGDx16
2:28pm August 24th 2016 via Hootsuite
Lee: Should represent pt population; there is a lack of reference methods and materials/stds. Also relevance to clinical outcomes #NGDx16
2:26pm August 24th 2016 via Hootsuite
Lee: Practical considerations for validation of ctDNA tests: clinical specimens may be limiting, insufficient, unavailable #NGDx16
Tezak: Complementary Dx - test not essential for safe and effective use of Rx. For both Companion and Complementary:same validation #NGDx16
2:22pm August 24th 2016 via Hootsuite
Lee: FDA policies for approval and labeling for CDx outlined. Link to PDF: https://t.co/SRFyiu7XTq #NGDx16
2:21pm August 24th 2016 via Hootsuite
Lee: There are 28 approved CDx for oncology, since the first approval in '98. '14 final guidance issued. CDx - info essential for Rx #NGDx16
2:19pm August 24th 2016 via Hootsuite
RT @LakshmanDx: @US_FDA keeping up with and committed to help #PrecisionMedicine #NGDx16 https://t.co/dQy6Qd5Bpb
2:18pm August 24th 2016 via Hootsuite
Eunice Lee (OIR, CDRH, FDA) A regulatory perspective on tumor gene panels and liquid biopsy diagnostics. #NGDx16
2:16pm August 24th 2016 via Hootsuite
Diehn: Clinical considerations - what's the gold std? Which applications most relevant? #NGDx16
2:15pm August 24th 2016 via Hootsuite
Diehn: Discussion questions - best technical approach? how to perform technical validation? #NGDx16
2:14pm August 24th 2016 via Hootsuite
Diehn: ctDNA is not necessarily the end-all, shows a funny Far Side 'veterinary science' cartoon. 70y from 1947 to 2016 (cobas) #NGDx16
2:13pm August 24th 2016 via Hootsuite
Deihn: Lovejoy '16 ref https://t.co/GLnB9OkWUP compares detection methods. 2.5 molecules out of 1M in their CAPP-Seq #NGDx16
2:10pm August 24th 2016 via Hootsuite
Diehn: Shows effect of 8 muts vs 1 mut - 90% prob of detection, from 0.1% vs 0.01% #NGDx16
2:08pm August 24th 2016 via Hootsuite
Diehn: Tracking multiple mutations increases sensitivity; 20ng cfDNA from 5mL plasma, 5K hGE's (assume 50% recovery) #NGDx16
2:07pm August 24th 2016 via Hootsuite
Diehn: Half-life is 0.5-2h; primarily from hematopoetic cells (60-80%) #NGDx16
2:06pm August 24th 2016 via Hootsuite
Diehn: About 175bp, typically 5ng/mL in healthy adults, higher in cancer, also infection, inflammation, trauma #NGDx16
2:04pm August 24th 2016 via Hootsuite
Max Diehn (Stanford): Starts the ctDNA section called 'Validating liquid biopsies'. ctDNA conc. range from <1pg/mL to >10ng/mL #NGDx16
2:03pm August 24th 2016 via Hootsuite
RT @h2so4hurts: Oh look, meeting has a 50/50 gender split, so of course 1/5 on the keynote panel is a woman. Come on... #NGDx16
12:34pm August 24th 2016 via Hootsuite
Mansfield: Concludes with intention of guidance - encouraging innovation, assure quality and reliability of NGS-based tests #NGDx16
11:53am August 24th 2016 via Hootsuite
Mansfield: Use of genetic databases - must be public, aggregated data, voluntary db recognition path (similar to stds) #NGDx16
11:51am August 24th 2016 via Hootsuite
Mansfield: May move to avoid pre-market review in the future. #NGDx16
11:50am August 24th 2016 via Hootsuite
Mansfield: Class-III (high risk) 'by default if we haven't seen it before'. Classified downward via de novo. #NGDx16
11:49am August 24th 2016 via Hootsuite
Mansfield: Need for comparator method (orthogonal validation); need for documentation of validation (really impt to FDA) w/CI's #NGDx16
11:47am August 24th 2016 via Hootsuite
Mansfield: 'We say it is up to you to indicate how many specimens needed for validation' but have to justify rationale #NGDx16
11:46am August 24th 2016 via Hootsuite
Mansfield: Need appropriate specimen type; can be very difficult; need to understand commutability of synthetic materials #NGDx16
11:45am August 24th 2016 via Hootsuite
