August 2018

Beer #NGDx18 Shows Supp Table 6 from '17 ref https://t.co/ZQSJLu4BRO PIK3CA status in tumor and ctDNA, comparing Sanger tissue to ctDNA

2:24pm August 22nd 2018 via Twitter Web Client

Beer #NGDx18 Herceptin - high PPA, NPA, stand-alone. If not high, then reflex.

2:22pm August 22nd 2018 via Twitter Web Client

Beer #NGDx18 37 approved CDx assays; 1 for ctDNA. Herceptin has 10 approved assays. Concordance.

2:17pm August 22nd 2018 via Twitter Web Client

Beer #NGDx18 Shows publication explosion in ctDNA, 649 papers in '17. BloodPAC for sharing information between stakeholders.

2:15pm August 22nd 2018 via Twitter Web Client

Beer #NGDx18 Another con: ave result of all ctDNA cannot differentiate somatic from germline, CHIP, or clonal var

2:14pm August 22nd 2018 via Twitter Web Client

Beer #NGDx18 Late-stage disease, get liquid biopsy. Pros: easily obtained, no crosslinking, 2h half-life, lower risk of sampling bias

2:11pm August 22nd 2018 via Twitter Web Client

Beer #NGDx18 Large regulatory group to create PMA, commercialization group.

2:08pm August 22nd 2018 via Twitter Web Client

Jonathan Beer (Novartis) #NGDx18 Challenges and opportunities of ctDNA plasma assays

2:05pm August 22nd 2018 via Twitter Web Client

Q: How to define TMB? Baden #NGDx18 A count of missense mutations. FMI - ns muts in the assay.

2:04pm August 22nd 2018 via Twitter Web Client

Baden #NGDx18 PPA at 6% with F1 assay and ctDNA. B-F1RST presented at ASCO, blood TMB score of >16.

2:01pm August 22nd 2018 via Twitter Web Client

Baden #NGDx18 prospective studies - B-FAST, BF1RST, shows 5 companies FMI, Guardant, PGDx, Grail, Predicine.

2:00pm August 22nd 2018 via Twitter Web Client

Baden #NGDx18 But tissue req's, sample var. Makes the case for liquid biopsy. 30% of pts with NSCLC have insuff tissue.

1:59pm August 22nd 2018 via Twitter Web Client

Baden #NGDx18 PFS 43% Nivo+Ipi, vs chemo 13%. Checkmate-227. FMI. Shows other companies - MSK-IMPACT, Personalis, Caris Tempus, TMO

1:57pm August 22nd 2018 via Twitter Web Client

Baden #NGDx18 OAK, POPLAR were blood TMB. https://t.co/dhqMA0ts8n ORR by TMB, cutoff in Checkmate 227 >10 muts/Mb

1:55pm August 22nd 2018 via Twitter Web Client

Baden #NGDx18 Frampton '13 Lawrence - very busy slides - Checkmate 227, 568, Keynote 055, -012 studies.

1:54pm August 22nd 2018 via Twitter Web Client

Baden #NGDx18 High TMB may increase immunogenicity of tumors, thus useful as a rational biomarker. Shows timeline from '13 on

1:53pm August 22nd 2018 via Twitter Web Client

Jonathan Baden (BMS) #NGDx18 Will blood change how we measure Tumor Mutation Burden (TMB)?

1:50pm August 22nd 2018 via Twitter Web Client

Cavanaugh #NGDx18 centralization? Ballmer: I-O CDx will drive centralization. At Roche, EU market was decentralized, but will change.

1:15pm August 22nd 2018 via Twitter Web Client

Ballmer #NGDx18 Like a fishing expedition. Mouradian Clinical utility holding everyone back. Murphy: GRAIL has a 2019 timeline.

1:14pm August 22nd 2018 via Twitter Web Client

Ballmer #NGDx18 Where's the return? How impacting pts lives? Is it just fanfare? Murphy: $ into WGS as well. At what point is there a pivot?

1:10pm August 22nd 2018 via Twitter Web Client

Cavanaugh #NGDx18 over-investment in genomics space? Ballmer: investment in liquid biopsy - $4B in 18 mos - $50M market size currently.

1:09pm August 22nd 2018 via Twitter Web Client

Ballmer #NGDx18 Keytruda approval - recently no longer need PDL1 status, and Agilent worked hard to produce first CDx for I-O Rx.

1:07pm August 22nd 2018 via Twitter Web Client

Ballmer #NGDx18 Concurs on the cost - and risk - for Dx partners. Tier 1 pharma has little interest. Always oppy for fee-for-service.

1:04pm August 22nd 2018 via Twitter Web Client

Mouradian #NGDx18 Dx co's taking risk, reimb. uncertain, Pharmas don't have a choice. FDA tells them they have to have a test.

1:03pm August 22nd 2018 via Twitter Web Client

Mouradian #NGDx18 Has been done once (rev sharing), but hard for approved CDx to make money. 'You can LDT around it all day long'

1:02pm August 22nd 2018 via Twitter Web Client

Cavanaugh #NGDx18 For CDx, what about Pharma: revenue sharing? Mouradian worked on CDx when he was w/Illumina. ~15 CDx today approved.

1:01pm August 22nd 2018 via Twitter Web Client

Mouradian #NGDx18 Divide along strong need in Dx (oncology, NIPT), also massive seq. Venture side: betting on WGS game. 'Get ready'.

1:00pm August 22nd 2018 via Twitter Web Client

Murphy #NGDx18 consumer genomics, liquid biopsy, and population genomics are the big 3 areas for Illumina

12:56pm August 22nd 2018 via Twitter Web Client

Murphy: #NGDx18 Covering this space now for 15y. Ballmer: VP of strategy, Cancer Dx for 15y. Mouradian was at ILMN for 6y

12:54pm August 22nd 2018 via Twitter Web Client

Bijwaard #NGDx18 What are key factors impacting circulating vs tissue status in cohorts outside Rx trials. Performance may be overstated.

12:28pm August 22nd 2018 via Twitter Web Client

Bijwaard #NGDx18 Pts enrolled based on tissue pos status; outcomes only on those pts. Plasma neg -> Reflext to tissue. Plasma pos -> R

12:27pm August 22nd 2018 via Twitter Web Client

Bijwaard #NGDx18 To select treatment: need to compare tissue to liquid biopsy. Matched sampling, clinical outcome based on liquid biopsy.

12:26pm August 22nd 2018 via Twitter Web Client

Bijwaard #NGDx18 Orthogonal method for accuracy; request validation of these mthods included w/submission

12:23pm August 22nd 2018 via Twitter Web Client

Bijwaard #NGDx18 Rec 20 replicates, serial dil's at 5-6 levels min 4 dilutions below LoD, 1 at LoD. And confirm using clin samples at LoD

12:21pm August 22nd 2018 via Twitter Web Client

Bijwaard #NGDx18 Contrived needs to 'demonstrate similar fragment sizes and background'

12:18pm August 22nd 2018 via Twitter Web Client

Bijwaard #NGDx18 Supplementing clinical specimens w/contrived, not to replace. Fn char across ranges, to show equivalence

12:18pm August 22nd 2018 via Twitter Web Client