Kudlow: ArcherDx aims to democratize NGS testing, easy-to-use kits and powerful data analysis for labs of all sizes. #NGDx17
12:42pm August 17th 2017 via Hootsuite
Brian Kudlow (ArcherDx) Increasing target spec to Reveal ctDNA from liquid biopsies by NGS #NGDx17
12:41pm August 17th 2017 via Hootsuite
Casdin: LabCorp - largest revenue, lowest multiple. Exact highest multiple due to growth. FMI high multiple. Enterprise value/Rev #NGDx17
12:28pm August 17th 2017 via Hootsuite
Casdin: Starting to see Dx industry 'swim back to the FDA first'. Exact first to do it via dual-path, now FMI #NGDx17
12:25pm August 17th 2017 via Hootsuite
Casdin: Four parts - product (support clinicians), service (drug industry enablement), approved (FA on-board), reimbursed (CMS) #NGDx17
12:24pm August 17th 2017 via Hootsuite
Casdin: LabCorp - from Covance purchase. Exact - highest valued pure Dx, serving exclusively physicians #NGDx17
12:23pm August 17th 2017 via Hootsuite
Casdin: Where is Dx/Rx today? LabCorp 30%, Invitae 10%, Exact 0%, FMI 66% (percent as biopharma revenues) #NGDx17
12:22pm August 17th 2017 via Hootsuite
Casdin: Whoa re your customers? What kind of business: lab, service, informatics? There are two markets - Rx and Dx, but one product #NGDx17
12:21pm August 17th 2017 via Hootsuite
Casdin: Shows the value is in therapeutics given the Dx part of that pie is miniscule. 'What business are you in?' #NGDx17
Messner: When payers feel more pressure to act, they will. #NGDx17
12:18pm August 17th 2017 via Hootsuite
Messner: Big private payers are 'hanging back a little bit', closely watching Palmetto and Guardant. "I thought it a smart thing" #NGDx17
12:17pm August 17th 2017 via Hootsuite
Gandera: Feels that NGS ctDNA is ready. Kopetz: Where tissue not available; sufficient to move forward. #NGDx17
12:16pm August 17th 2017 via Hootsuite
Moderator: ctDNA ready for prime-time in NSCLC? Gandera: Approved in the US in EGFR-mut for 2y in US/EU. Q is if NGS is preferable #NGDx17
12:14pm August 17th 2017 via Hootsuite
Eli Casdin (Casdin Capital) Investment perspective #NGDx17 What's the business behind the technology? How value is viewed, product strategy
12:11pm August 17th 2017 via Hootsuite
Kopetz: At MDACC ctDNA is used where no tissue avail, before and after hi-risk surgery for MRD, before and on trtmtn with chemo resp #NGDx17
12:09pm August 17th 2017 via Hootsuite
Kopetz: ASCO17 they reported tissue and ctDNA in mCRC at 93% accuracy. 92% sens, 94% spec #NGDx17
12:02pm August 17th 2017 via Hootsuite
Kopetz: Another gap: test needed vs tissue available. For CRC: NGS of 180 genes, RNA fusion, MSI by IHC, MSI by PCR, HER IHC #NGDx17
12:01pm August 17th 2017 via Hootsuite
Kopetz: Also tumor heterogeneity. Access: 23% at MDACC for lung QNS. For mCRC, 70% chemo and surgery are different locations #NGDx17
12:00pm August 17th 2017 via Hootsuite
Kopetz: Screening, recurrence detection, metastatic disease. Utility: access to tumor, speed, rapid dynamics, resistance assessment #NGDx17
11:58am August 17th 2017 via Hootsuite
Scott Kopetz (MDACC TX) Value from the perspective of a GI oncologist #NGDx17
11:57am August 17th 2017 via Hootsuite
Gandara: Shows an example of chasing mutations in ctDNA in course of trtmt. "Plasma First" method. #NGDx17
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
