September 2019

Becker #worldcdx No single tech nor biomarker can provide a complete profile. IHC, ISH, PCR, NGS Dx, vs SNV, indel, CNV, xloc, GEx, protein

2:06pm September 11th 2019 via Twitter Web App

Becker #worldcdx Dx testing truths: "biology is complex and Google Maps for cell signaling does not exist"

2:05pm September 11th 2019 via Twitter Web App

Kathryn Becker (Abbott Molecular) #worldcdx Avoiding the Pitfalls & Setbacks in CDx Development: Reflections on 12 Years of Experience

2:04pm September 11th 2019 via Twitter Web App

Q: Prevelance in plasma? Merkle #worldcdx Less in plasma - about 2% observed, compared to about 3% in tissue.

1:57pm September 11th 2019 via Twitter Web App

Merkle #worldcdx Today was notified of 'breakthrough status' from the FDA.

1:53pm September 11th 2019 via Twitter Web App

Merkle #worldcdx Oral ASCO 2019 abstract here: https://t.co/y0H1VevZLj VISION study still in-progress, 'is looking good so far'.

1:48pm September 11th 2019 via Twitter Web App

Merkle #worldcdx MET is a receptor tyrosine kinase; highly oncogenic. EMD has dev Topotinib, highly selective, potent in-vitro.

1:34pm September 11th 2019 via Twitter Web App

Dennis Merkle (Merck KGaA) #worldcdx Investigational Tepotinib: MET Exon 14 Skipping & the Power of Precision Medicine

1:33pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Bring test to sample, or reverse? With a central lab: global footprint, on-site path, qualified IVD partners

12:22pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Feels we may see more ssPMA / limited dist model, due to complexity. ssPMA: how to distribute once approved?

12:21pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Dual plex IHC, RNA ISH, Multiplex ISH: may need a different approval path.

12:20pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Shows large menu of capability to support CDx. Multiplex IHC: to char cell-cell interactions. Has a place in clin dev

12:19pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Liquid biopsy: agnostic (Archer, Oncomine, TSO500, PGDx Elio). 'Each tech has strengths dep on intended use'

12:18pm September 11th 2019 via Twitter Web App

Wookey #worldcdx One acquisition: Biofortis, to rescue failed/suboptimal trials. Pull samples, get e-consent

12:17pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Multiple tech for one biomarker: a new paradigm? Challenges: local handling of blood for cfDNA

12:16pm September 11th 2019 via Twitter Web App

Wookey #worldcdx PD-L1 capability >50 studies in China 2014-19. NMPA '18 4 CDx approvals, all retrospective. No 'co-dev' there.

12:15pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Q2 put lab with many different technology - IHC, FISH, Elisa, PCR, NGS, Nanostring: an regulatory expertise nearby

12:14pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Now in 2019: 400 Ph I studies, some bias towards gastric and head&neck. Molecular targets all amenable to CDx

12:13pm September 11th 2019 via Twitter Web App

Wookey #worldcdx China: have started at PMU in Beijing. Iressa IPASS Ph 3 trial 2005-09.

12:13pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Showed cancellation rate decreasing by 50% as a result.

12:11pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Insuff / poor quality sample: education pkgs, investigator mtgs, standardizing collection

12:08pm September 11th 2019 via Twitter Web App

Wookey #worldcdx One thing that hasn't changed: 3/4ths are IHC-based. Ex. PD-L1, 30K tested, 6 assays. 4.2% cancellation rate data

12:08pm September 11th 2019 via Twitter Web App

Wookey #worldcdx Pharma (science/clinical/regulatory/commercial), works with CRO and IVD partner.

11:59am September 11th 2019 via Twitter Web App

Alan Wookey (Q2 Solutions) #worldcdx Delivering Successful Companion Diagnostics Programs: A Large Global Central Laboratory’s Experience

11:58am September 11th 2019 via Twitter Web App

Wohlgemuth #worldcdx Pts are getting clin trials info on the internet anyway...

11:51am September 11th 2019 via Twitter Web App

Freeman #worldcdx They also have a pharma analytics and clinical trial service offering Clinical Trials Connect https://t.co/UGfCtii3TB

11:49am September 11th 2019 via Twitter Web App

Freeman #worldcdx Only 33% of Americans are aware of clinical trials. Expert determination: de-identified Pt info, generate a hashed token

11:41am September 11th 2019 via Twitter Web App

Wohlgemuth #worldcdx At the population level (36K US members) ID'd ~7500 unrecognized cases of chronic disease.

11:27am September 11th 2019 via Twitter Web App

Wohlgemuth #worldcdx Showed reduction of 1% in overall claims (first time in 10y).

11:27am September 11th 2019 via Twitter Web App

Wohlgemuth #worldcdx Testing for diabetes, collect at home and sent back at RT, https://t.co/UGYYFkD6q6 for YouTube video

11:24am September 11th 2019 via Twitter Web App

Wohlgemuth #worldcdx 'There is something to be said about convenience'. Home-based self-collection the most convenient.

11:23am September 11th 2019 via Twitter Web App

Wohlgemuth #worldcdx All the annotation assoc'd with a phenotype. 6/10 adults in the US have a chronic disease; 4/10 have two or more (!)

11:17am September 11th 2019 via Twitter Web App

Wohlgemuth #worldcdx Shows a busy slide of all that it involves to implement genetic testing as a diagnostic. And on top: a data commons

11:16am September 11th 2019 via Twitter Web App

Wohlgemuth #worldcdx Not only diagnostic services but also information services, and population health.

11:15am September 11th 2019 via Twitter Web App

Jay Wohlgemuth (CMO) and David Freeman (Quest Diagnostics) Enabling population health and precision care #worldcdx

11:13am September 11th 2019 via Twitter Web App

Toft #worldcdx Concludes with one word: Confidence. Along with competence and commitment, 'we'll all win'.

11:11am September 11th 2019 via Twitter Web App

Becker #worldcdx Creating value is good; sometimes it's good to talk about what you have done (and take credit for it)

11:03am September 11th 2019 via Twitter Web App

Ballmer #worldcdx A mentor of hers said 'at the C-level, 30% of your time needs to be spent networking'

11:00am September 11th 2019 via Twitter Web App