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
Lichtenfeld: Sometimes the tech gets ahead of the application. Getting to a point with ctDNA as early det; will we know what to do? #NGDx17
11:51am August 16th 2017 via Hootsuite
Plenary session at #NGDx17 on D.C. policy and prediction for diagnostics https://t.co/tYjHV8R83u
Bennett: Now a separate line on the cost sheet for PAMA. Overheads are different. Can you imagine what it is for conjoined twin? #NGDx17
11:48am August 16th 2017 via Hootsuite
Fish: AdvaMedDx developed a value-based framework, how to explain value to different stakeholders, and what the value case is #NGDx17
11:45am August 16th 2017 via Hootsuite
Fish: Reimbursement - for manufacturers, what evidence is needed. Demonstration of value to their customers, whoever they may be #NGDx17
11:44am August 16th 2017 via Hootsuite
Fish: Long advocated for unified treatment of tests based on risk. Engaged w/ongoing debate of regulation. #NGDx17
11:42am August 16th 2017 via Hootsuite
Fish: May not all agree but all have the same goals. Envision a full leverage of Dx tests to improve public health. Regulation/reimb #NGDx17
11:41am August 16th 2017 via Hootsuite
Khani: Sees opportunity for LDTs to come to market with a strengthened CLIA for review by FDA #NGDx17
#NGDX17 con't Panelists Andrew Fish AdvaMedDx Michael Bennett (U Penn/CHOP) Leonard Lichtenfeld (ACS)
11:38am August 16th 2017 via Hootsuite
#NGDx17 Washington Insight: policy & prediction for Diagnostics. Bruce Quinn, Alberto Gutierrez (FDA) Mary Williams (AMP) Julie Khani (A
11:37am August 16th 2017 via Hootsuite
Qa; Why rh-based blocking only now? Jarosz: Why IDT opened up a San Francisco office, to develop tech they've had a long time #NGDx17
10:22am August 16th 2017 via Hootsuite
Q:'Barcode hopping has been driving us nuts' b/c of seq error Jarosz: Designed to e 2-3 errors apart, but at <1%, is all relevant #NGDx17
10:21am August 16th 2017 via Hootsuite
Jarosz: Have an rhAmp allele-specific PCR for SNP genotyping. Showed data w/collaborator for IDH1/2, implemented as an LDT at MGH #NGDx17
10:19am August 16th 2017 via Hootsuite
Jarosz: Took an add'l 49 commercial tumor tissue/plasma/normal tissue triads. A full 10% had not correct genotypes (!) #NGDx17
10:16am August 16th 2017 via Hootsuite
Jarosz: AstraZeneca (AZ) used 15 matched FFPE/plasma. 20% didn't have matching SNPs (!) #NGDx17
Jarosz: rhPCR - IDT has blocked the 3 end, with unique DNA:RNA hybrid primers. 3' blocker allows specificity compared to std primers #NGDx17
10:14am August 16th 2017 via Hootsuite
Jarosz: Sample mixups can (and do) occur, refers to NY piece https://t.co/Wma2W1Edky #NGDx17
10:13am August 16th 2017 via Hootsuite
Jarosz: IDT is partnering with Illumina on implementing this quickly, getting scale on many barcodes for the NovaSeq capacity #NGDx17
10:11am August 16th 2017 via Hootsuite
Jarosz: IDT worked on unique dual-indices, reducing cross-talk a '3-in-1' design. P5, i5 Index, insert, i7 index, UMI, P7 #NGDx17
10:10am August 16th 2017 via Hootsuite
Jarosz: Points to Sinha bioArXiv https://t.co/OLEJHRBLaO and Illumina's response #NGDx17
10:07am August 16th 2017 via Hootsuite
Jarosz: Shows 1- to 16-plex index hopping, on the order of 0.03%. Impt w/low frequency variation. #NGDx17
10:06am August 16th 2017 via Hootsuite
