Phillip Brohawn (MedImmune) Application of NGS to Drug Development #NGSDx17
8:39am August 17th 2017 via Hootsuite
Great AM session roundtable on biomarker technology for I-O and CDx w/Michael Montalto (BMS) David Rimm (Yale) and others! #NGDx17
Annular Eclipse of the Sun by Phobos, as Seen by Curiosity | NASA https://t.co/7bgeUXijYc
5:30am August 17th 2017 via Hootsuite
Sequencing of Circulating Tumor DNA Detects Early Cancers | GenomeWeb https://t.co/DwwHduNTGK
8:20pm August 16th 2017 via Hootsuite
RT @biorxivpreprint: Detection and removal of barcode swapping in single-cell RNA-seq data https://t.co/stMf1yURdn #bioRxiv
7:50pm August 16th 2017 via Hootsuite
RImm: All but two complementary - b/c 'they didn't work'. "I'm not doing a complementary test, no reimbursement, pt will get anyway' #NGDx17
6:11pm August 16th 2017 via Hootsuite
RImm: Shows many papers of PD-L1 by IHC in NSCLC. "There is signal there" Shows approval timelines '11-'17 of I-O 'it's amazing' #NGDx17
6:09pm August 16th 2017 via Hootsuite
RImm: 'Quite a good test' but also 'can we get this lame test to work?' #NGDx17
6:08pm August 16th 2017 via Hootsuite
RImm: Has a lot of disclosures - 'I need partners'. Outline - talking about PD-L1, IHC, standardization of PD-L1 today's test #NGDx17
6:07pm August 16th 2017 via Hootsuite
David Rimm (Yale CT) Companion diagnostics for immunotherapy: Challenge of picking the responders #NGDx17
6:05pm August 16th 2017 via Hootsuite
Li: Had prospective study with ResolutionBio of Seattle, how it could impact pt care #NGDx17
5:48pm August 16th 2017 via Hootsuite
Li: Shows figure of all the liquid biopsy assay providers - ILMN, Q, Genomic Helath, Guardant, Myriad, exosomeDx, PGDx, Pathway, FMI #NGDx17
5:47pm August 16th 2017 via Hootsuite
Li: Found instances where ddPCR missed where NGS picked up. Collab w/GRAIL, 'clonal muts more likely to be detected in plasma' #NGDx17
5:43pm August 16th 2017 via Hootsuite
Li: Showed EGFR and ERBB2 ampl in plasma ctDNA, results presented at AACR '16. Cp to ddPCR and NGS, 'sensitivity as good' #NGDx17
5:42pm August 16th 2017 via Hootsuite
Li: Showed several cases from this '17 ref https://t.co/PmS2lAzHHG #NGDx17
Li: Describes MSK-IMPACT, and limitations of scaling number of samples. But still did 10K samples '17 ref https://t.co/Z2m3cjRt6H #NGDx17
5:39pm August 16th 2017 via Hootsuite
Li: T790M by ddPCR is now 'std of care' for MSK pts with metastatic EGFR who progress. #NGDx17
5:36pm August 16th 2017 via Hootsuite
Bob Li (MSKCC) Utility of ctDNA for patients at MSKCC #NGDx17
5:35pm August 16th 2017 via Hootsuite
Bijwaard: FDA-AACR workshop Liquid Biopsies in Oncology Drug and Device Development Part II Oct 10 2017 https://t.co/a2OgudvlgL #NGDx17
5:29pm August 16th 2017 via Hootsuite
Bijwaard: Poorer result - PPA 58.7%. PPV 89%. OOR rate by plasma result status among enrolled patients w/confirmed responses #NGDx17
5:24pm August 16th 2017 via Hootsuite
Bijwaard: 2nd indication was for Tagrisso (T790M resistance). Clinical bridging study AURA2. #NGDx17
5:23pm August 16th 2017 via Hootsuite
Bijwaard: PFS benefits to pts who are tissue whether plasma pos or neg. Approval - reflex to routine biopsy for EGFR status #NGDx17
5:22pm August 16th 2017 via Hootsuite
Bijwaard: Shows 22/212 had 1.5-1.9mL; 17/212 had 0.4-1.4mL. Had PPA across n=431 of 76.7%. High NPA 98.2% #NGDx17
5:21pm August 16th 2017 via Hootsuite
Bijwaard: Reviews cobas EGFR Mut Test v2 - ENSURE study. An issue was 2.0mL plasma not available for all 212 pts. #NGDx17
5:20pm August 16th 2017 via Hootsuite
RT @DXWorldNews: Always a treat to hear from @DaleYuzuki His insights are spot on. Congrats on the new gig at Pillar Biosciences! #NGDx17 h…
5:15pm August 16th 2017 via Hootsuite
Bijwaard: Specimen collection and processing should follow same protocol; clinical trial assay used for pt enrollment #NGDx17
Bijwaard: DNA input and MAF 'down to the lowest levels' #NGDx17
5:12pm August 16th 2017 via Hootsuite
Bijwaard: Roche's SSED needed to be renamed. same vars, same conc, 5 dil levels from est LoD down to est LoB. #NGDx17
Bijwaard: Need to demonstrate similar fragment sizes, background. Functional char formerly referred to commutability study #NGDx17
5:11pm August 16th 2017 via Hootsuite
Bijwaard: Contrived specimens intended to supplement, not replace, clinical ones. Functional char study across ranges #NGDx17
5:10pm August 16th 2017 via Hootsuite
Bijwaard: Due to limited specimens for ctDNA - may pool patient specimens, start w/extracted DNA, or procure specimens #NGDx17
5:09pm August 16th 2017 via Hootsuite
Bijwaard: Impt to validate pre-analytical factors (collection, process plasma time). Representative variant approach not yet for ct #NGDx17
5:06pm August 16th 2017 via Hootsuite
Bijwaard: IVD - markers intended to guide Rx w/drug or monitoring. Analytical validation challenges w/low DNA, MAF levels #NGDx17
5:05pm August 16th 2017 via Hootsuite
Bijwaard: Shows screenshot of the FDA guidance given in 2014 for CDx https://t.co/NTSaxHZK9Y #NGDx17
5:04pm August 16th 2017 via Hootsuite
Karen Bijwaard (CDRH FDA): Regulatory perspectives of cf/ctDNA of in vitro diagnostic tests #NGDX17
5:02pm August 16th 2017 via Hootsuite
Morin: For a proof of concept, simple PCR of KRAS. Showed both G12D and WT being detected #NGDX17
4:06pm August 16th 2017 via Hootsuite
Morin: Shows ave 5 ng/mL of cfDNA from urine, 9 samples, used in-house method. Showed encouraging results between plasma / urine #NGDX17
4:03pm August 16th 2017 via Hootsuite
Trevor Morin (CSO) working w/ Ko from UCSF, Late stage CR ca, blood and urine samples G12D #NGDX17
4:01pm August 16th 2017 via Hootsuite
Heller: Take existing reagents, use same IP for the assay, bring to POC setting. Long list of current confirmed assays. #NGDX17
3:57pm August 16th 2017 via Hootsuite
Heller: Their IP is around obtaining signal and removing from background. open-systems development environment. All about partners #NGDX17
3:56pm August 16th 2017 via Hootsuite
Heller: #NGDX17 (For those interested - I wrote this up a few months ago. https://t.co/IqqWWAMQwd )
3:55pm August 16th 2017 via Hootsuite
Heller: Do not do sequencing, but detect molecules, and individual target sequences. Can have more than one chip, reader device #NGDX17
3:54pm August 16th 2017 via Hootsuite
Dan Heller (Two Pore Guys CA) ctDNA Mutation Detection and Quantitation using Handheld Nanopore-Based System #NGDx17
3:52pm August 16th 2017 via Hootsuite
Ferrara: The test launch-planning: market landscape, sample journey, market auth, test quality, coding, health tech assessment #NGDx17
3:37pm August 16th 2017 via Hootsuite
Ferrara: Kinds of tests: PD-L1 IH w/4 Abs. MSI MMR (3 providers). TMB (FoundationOne) GEX "in development" #NGDx17
3:36pm August 16th 2017 via Hootsuite
Ferrara: Top unmet needs among oncologists: info overload, help with interpretation. #NGDx17
3:35pm August 16th 2017 via Hootsuite
Ferrara: Drugs, combinations, indications, antibodies, PD-L1 thresholds, not to mention targets, overlaid onto countries and payors #NGDx17
3:34pm August 16th 2017 via Hootsuite
Joseph Ferrara (Boston Healthcare) Cdx for Immuno-onocology - global commercial and partnership considerations #NGDx17
3:33pm August 16th 2017 via Hootsuite
Strickler: Shows data from a pt where a MET ampl was missing from tumor but found in plasma. #NGDx17
3:14pm August 16th 2017 via Hootsuite
Strickler: Does blood equal tissue? Shows many data slides they presented at ASCO 2017 (no link, can't find at JCO) #NGDx17
3:10pm August 16th 2017 via Hootsuite
