Gandara: From this '14 ref https://t.co/DruvgJNsB9 100 pts, 18 no biopsy, 21 low cellularity. n=61 (out of 100) interpretable #NGDx17
11:54am August 17th 2017 via Hootsuite
David Gandara (UC Davis CA) Clinician's perspective: interface of cancer therapeutics and liquid biopsy #NGDx17
11:45am August 17th 2017 via Hootsuite
Albas: Want results in the genomic data commons. Technical assessment process M00095 https://t.co/Oz3aLfYThz #NGDx17
Albas: Specifics on analytic performance guidelines for ctDNA M00135 https://t.co/75LxrAN7tl #NGDx17
11:43am August 17th 2017 via Hootsuite
Albas: The MolDx manual https://t.co/4j0F0vmt3v Coding and billing guidelines https://t.co/nWzie8FRMX #NGDx17
11:41am August 17th 2017 via Hootsuite
Almas: There was a problem with CF testing stacking codes. MolDx developed a unique ID code w/followup, accountability #NGDx17
11:39am August 17th 2017 via Hootsuite
Almas: There are MOUs in place with contractors. MolDx assists in CA, and four others. ACCE criteria used. NCD is Rev 192 5-6-16 #NGDx17
11:37am August 17th 2017 via Hootsuite
Almas: FISH testing is under NCD190.3, the only type of molecular test covered nationally. Medicare reimbursement is via contractors #NGDx17
11:36am August 17th 2017 via Hootsuite
Almas: NCD = national coverage determination; LCDs may be established in the absence of an NCD. There are no NCDs in this NGS space #NGDx17
11:35am August 17th 2017 via Hootsuite
Jim Almas (Palmetto GBA MolDx): Reimbursement from the CMS Perspective #NGDx17
11:33am August 17th 2017 via Hootsuite
Messner: Payer wants evidence that the patient has benefitted from this. Figure from AdvaMed report https://t.co/blp98J4gQF #NGDx17
11:30am August 17th 2017 via Hootsuite
Messner: For liquid biopsy: slow adoption when existing tech is standard: is it medically necessary? #NGDx17
11:27am August 17th 2017 via Hootsuite
Messner: Some payers have started to cover <50 gene panel in CLIA/CAP labs (esp NSCLC). Palmetto recently issued LCD #NGDx17
11:26am August 17th 2017 via Hootsuite
Messner: >=5 guideline-directed genes, when cost of 5 is < than separate. >50 genes: unproven. 'consider when no other option' #NGD
11:24am August 17th 2017 via Hootsuite
Messner: Private payers felt it was 'soft' form of coverage w/evidence development (CED). Some consensus on 5-50 gene panels. #NGDx17
11:23am August 17th 2017 via Hootsuite
Messner: 'how do we know this method gives the same info as Sanger?' 'why is a 50 gene panel is medically necessary?' #NGDx17
11:21am August 17th 2017 via Hootsuite
Messner: 'if every gene on a panel doesn't have CU for the pt then the panel does not have CU' 'then it is a fishing expedition' #NGDx17
Messner: Terms like 'clinical utility', 'investigational', 'medical necessity' taken from single-gene paradigm and applied to NGS. #NGDx17
11:20am August 17th 2017 via Hootsuite
Messner: Recommended clin validity and utility of MDx test in adult oncology '13; '14-'15 workgroups, stakeholders. '15 rec's #NGDx17
11:19am August 17th 2017 via Hootsuite
Messner: Challenge is a bottleneck; 'thousands' of genetic test without coverage, due to lack of evidence. Problem now exacerbated #NGDx17
Messner: Focus of their non-profit - payor coverage project, implications for liquid biopsy #NGDx17
11:18am August 17th 2017 via Hootsuite
Donna Messner (Ctr for Med Technology Policy): Implementing next gen sequencing coverage policies and providing value #NGDx17
11:17am August 17th 2017 via Hootsuite
Skyzpczak: I-O 'changes the cost and care paradigm'. Questions - liquid biopsies 'ready for primetime'? Complementary to tissue? #NGDx17
11:15am August 17th 2017 via Hootsuite
Skyzpczak: Liquid biopsy: NCCN 'plasma should be considered if repeat biopsy not available', others. Fig https://t.co/l9IAZCyHHi #NGDx17
11:12am August 17th 2017 via Hootsuite
Stan Skyzpczak (Guardant) Intro comments: how can rates of genomic testing in NSCLC be improved? '17 ref https://t.co/ppyL8pahWm #NGDx17
11:10am August 17th 2017 via Hootsuite
Fabrizio: Shows data from BIRCH, FIR and POPLAR trials, high TMB assoc'd with I-O based survival in NSCLC #NGDx17
9:20am August 17th 2017 via Hootsuite
Fabrizio: Show fig from '16 lancet https://t.co/iW5BG7Rtsc TMB and anti-PDL1 OS in mUrothelial Carcinoma, clear difference #NGDx17
9:19am August 17th 2017 via Hootsuite
Fabrizio: Data leads to basket trials that are disease-type agnostic (i.e. Merck) #NGDx17
9:16am August 17th 2017 via Hootsuite
Fabrizio: Shows box-and-whisker around all indications (many dozens), distribution of TMB. Shows 5 I-O approved, 4 likely #NGDx17
9:15am August 17th 2017 via Hootsuite
Fabrizio: Accuracy 90%; precision 96%; LoD 20% tumor purity for analytical validation for TMB (Cp against WES TMB calling) #NGDx17
9:13am August 17th 2017 via Hootsuite
Fabrizio: Then count somatic mutations/megabase. Same test workflow; ranking of hi/med/lo, shows I-O OS via K-M curve in Melanoma #NGDx17
9:11am August 17th 2017 via Hootsuite
Fabrizio: TMB algorithm, built a db of rare germline events; somatic-germline zygosity modeling (copy number) are specialty filters #NGDx17
9:10am August 17th 2017 via Hootsuite
Fabrizio: FMI looked at TCGA data, and downsampled '17 Genome Med https://t.co/EU6oCnzxyM #NGDx17
9:08am August 17th 2017 via Hootsuite
Fabrizio: FMI was 315 genes, 203, 160, 76 genes with assoc'd Kaplan-Meier curves show effect of downsample #NGDx17
9:05am August 17th 2017 via Hootsuite
Fabrizio: '15 Oncotarget ref https://t.co/BwNpKlrl8S downsampled WES to predict clinical utility to a FMI 315 panel #NGDx17
9:04am August 17th 2017 via Hootsuite
Fabrizio: Can a panel be equivalent to WES for TMB? Faster TAT (FMI is 10d TAT), cheaper, no matched normal needed #NGDx17
9:03am August 17th 2017 via Hootsuite
For those following #NGDx17 at home, check out @Pillar_Bio updated website next week; my take is at https://t.co/aeiuCtplgb
9:02am August 17th 2017 via Hootsuite
Fabrizio: Pieces of the puzzle over time include MSI, TCR, TMB, GEX, (unk). Shows Chen/Mellman figure from '13 Cancer Immunity Cycle #NGDx17
9:00am August 17th 2017 via Hootsuite
Fabrizio: Show Larkin NEJM 2015 of durable benefit on Ipi or Nivo either 20% or 40% in melanoma https://t.co/GKpERVWbPu #NGDx17
8:58am August 17th 2017 via Hootsuite
Fabrizio: Need to think of patient's cancer not as organ-specific but driver mutation-specific. 'Everyone is a snowflake'. #NGDx17
8:56am August 17th 2017 via Hootsuite
Fabrizio: 300 gene panel test gives also MSI and TMB; ability for comp. profiling 'has opened the door for personalized medicine' #NGDx17
David Fabrizio (Foundation Medicine MA) Tumor mutational burden as a biomarker for cancer immunotherapy #NGDx17
8:54am August 17th 2017 via Hootsuite
RT @FoundationATCG: Join us at #NGDx17 for a 9AM presentation on TMB as a biomarker for immunotherapy based on clinical evidence from CGP t…
Brohawn: And conversely, increased difference in VAF meant shorter PFS probability #NGDx17
8:48am August 17th 2017 via Hootsuite
Brohawn: Shows data from AACR Abstract 582 CP1108 NSCLC: ctDNA mutations over time. Mutations shown that decreasing VAF w/inc PFS % #NGDx17
Brohawn: Two FDA PMA approvals - Foundation Focus and Oncomine Dx. Guardant 360 panel also illustrating broad coverage of drivers #NGDx17
8:45am August 17th 2017 via Hootsuite
Brohawn: Rizvi '15 TMB https://t.co/rwa2cxqwCu 'expanding evidence' for its role in I-O #NGDx17
8:43am August 17th 2017 via Hootsuite
Brohawn: Feels targeted RNAseq 'overlooked'. Able to go at low-levels - '15 ref https://t.co/C8rfXh4E80 #NGDx17
8:42am August 17th 2017 via Hootsuite
Brohawn: scRNASeq - may find Treg and other cell types. May help unlock best Rx strategy, 'still evolving, interesting application' #NGDx17
8:41am August 17th 2017 via Hootsuite
Brohawn: Starts with review of some of their RNASeq work, shared at ASCO17. 'Potential for exciting application: scRNAseq' #NGDx17
8:40am August 17th 2017 via Hootsuite
