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
Strickler: Becomes an issue: calc of sens 38% - 95%; PPV 29%-80%. #NGDx17
3:04pm August 16th 2017 via Hootsuite
Strickler: Shows AZ's poster from AACR, shows all the variation between CRO vendors. TP/FP/FN "fairly profound differences" #NGDx17
Strickler: Tissue's cost - liver is $2k-$7K for biopsy. Lung is $8.8K to $37.7K if complications. #NGDx17
2:59pm August 16th 2017 via Hootsuite
Strickler: With 45 pts at Duke, 15% had KRAS or EGFR muts and still received Ab Rx. #NGDx17
2:58pm August 16th 2017 via Hootsuite
Strickler: KRISTAL, PRIME clinical trials, changing guidelines as a result. MDACC, 23% of pts due to QNS of tissue for genotyping #NGDx17
2:57pm August 16th 2017 via Hootsuite
Strickler: Clinical need: targeting driver mutations '14 JAMA https://t.co/QJiA01dJyY #NGDx17
2:56pm August 16th 2017 via Hootsuite
John Strickler (Duke) Optimizing use of ctDNA to accelerate clinical discoveries #NGDx17
2:53pm August 16th 2017 via Hootsuite
Gandara: Guidelines changing - shows CAP/IASLC/AMP coming out in 'about 3 mos'. When: before initial Rx, certain progressions #NGDx17
2:50pm August 16th 2017 via Hootsuite
Gandara: Adv of ctDNA: non-invasive, tumor heterogen reflected, can be repeated over time, can detect resistance before radiography #NGDx17
2:42pm August 16th 2017 via Hootsuite
Gandara: Shows case of Crizotinib, after progression then Alectinib, then ALK I1171T, then another Rx. #NGDx17
2:39pm August 16th 2017 via Hootsuite
Gandara: Beyond crizotinib, lists certinib, alectinib, brigatinib, lortatinib 2nd / 3rd line TKI Rx. Shows complex plot of resist #NGDx17
2:38pm August 16th 2017 via Hootsuite
Gandara: Shows complex pie diagram by mutation type, druggable targets for NSCLC. #NGDx17
2:34pm August 16th 2017 via Hootsuite
Gandara: Predictive biomarkers: FoundationOne test - assess the landscape, Sensitivity: shows tech vs. frequency from 25% now 0.1% #NGDx17
2:32pm August 16th 2017 via Hootsuite
Gandara: Message to oncologists: for any I-O "you need to test". #NGDx17
2:28pm August 16th 2017 via Hootsuite
Gandara: CheckMate-026 TMB negative study Nivo vs Chemo, but still a subgroup still benefitted #NGDx17
2:27pm August 16th 2017 via Hootsuite
Gandara: #NGDx17 New 2nd gen Rx recent '17 NEJM https://t.co/lxfibvMq9e
2:25pm August 16th 2017 via Hootsuite
Gandara: Shows first-in-human crizotinib Ph 1 in ALK-+ lung ca. Waterfall plot: best to treat w/targeted drug #NGDx17
2:24pm August 16th 2017 via Hootsuite
Gandara: Melanoma, lung squamous lead mutational load chart. 40 pts w/adv NSCLC: look alike, but all different: PD-L! and genomics #NGDx17
2:21pm August 16th 2017 via Hootsuite
Gandara: NSCLC instead of one disease, EGFR and ALK fusions subdivide. PD-L1 expression around 50% prevalance. Mutation load data #NGDx17
2:20pm August 16th 2017 via Hootsuite
David Gandara (UC Davis) Evolution and increasing complexity of cancer biomarker testing: NSCLC as a model #NGDx17
2:19pm August 16th 2017 via Hootsuite
Bennett: Anyone have a baby here? The blood test for babies are an LDT. #NGDx17
12:09pm August 16th 2017 via Hootsuite
Quinn: Companies who want to bundle. Bennett: Need to talk about medical technologies. Biggest concerns: pre-existing LDTs. #NGDx17
12:08pm August 16th 2017 via Hootsuite
Lichtenfeld: And these cost are less, and the quality is high. A threat - and an opportunity. #NGDx17
12:07pm August 16th 2017 via Hootsuite
Lichtenfeld: Now we have molecularly sub-typed cancer. How to deliver it where the patients are? "We need to move in this direction" #NGDx17
12:06pm August 16th 2017 via Hootsuite
Lichtenfeld: But how many clinicians have 'any clue' what it all means? You need resources, people to make the connections. #NGDx17
Lichtenfeld (ACS) Disruptors are DTC companies, they are well-done, Anyone can now get 'full sequencing' and access to trials #NGDx17
12:05pm August 16th 2017 via Hootsuite
Quinn: Points out Sema4, Intermountain, OmniSeq as spin-outs from academic labs. For Intermountaing, a place for telemedicine etc #NGDx17
12:00pm August 16th 2017 via Hootsuite
Carrington: Mentions FDA Oncology Center of Excellence, to be interdepartmental. #NGDx17
11:57am August 16th 2017 via Hootsuite
Lea Carrington (replacing Gutierrez representing FDA): 36 CDx approved; 17 cancer Rx, 11 molecular markers in the past 20y #NGDx17
11:54am August 16th 2017 via Hootsuite
