September 2019

Shaw #worldcdx But pts are generally not retested. Resistance is tested via LBx.

4:44pm September 11th 2019 via Twitter Web App

Q: What types of computational considerations? Shaw #worldcdx For the KB - can be rerun at any time. But manual curation of lit is req'd

4:44pm September 11th 2019 via Twitter Web App

Shaw #worldcdx May need to look at treating cancer earlier with PM - not in late-stage disease. 'We need to treat it as if we know it'

4:42pm September 11th 2019 via Twitter Web App

Shaw #worldcdx Looking at co-mutations in lung cancer - ID Rx vulnerabilities. Skoulidis Cancer Disc 2015 https://t.co/vU25fFHefH

4:41pm September 11th 2019 via Twitter Web App

Shaw #worldcdx N.B. @kennamshaw is speaking with such clarity - awesome talk!

4:40pm September 11th 2019 via Twitter Web App

Shaw #worldcdx Pt not eligable early, become eligable later but early report used. 40 new biomarkers in 18 mos.

4:35pm September 11th 2019 via Twitter Web App

Shaw #worldcdx No standard rules - shows same patient, two different reports, two different rec's. But need to evolve decision support

4:34pm September 11th 2019 via Twitter Web App

Shaw #worldcdx Came up with literature, aggregate data, annotate fn significance. "One person's VUS is another person's enrollment criteria"

4:33pm September 11th 2019 via Twitter Web App

Shaw #worldcdx Of the reminder: 124/354 refused second line. Now 230 came back for 2L: but only 69% had test results mentioned.

4:30pm September 11th 2019 via Twitter Web App

Shaw #worldcdx 17% of the pts never came back. Got tested, sought Rx, and pt never knew they had an actionable result, never were contacted.

4:29pm September 11th 2019 via Twitter Web App

Shaw #worldcdx Whether 50 genes, 500 genes, or WES: only 125 actionable genes to work with. MD Andersen - why is this so hard?

4:25pm September 11th 2019 via Twitter Web App

Shaw #worldcdx Of the 32% - 7% standard Rx, 25% clinical trial/off-label. Need to move pts to clin trials.

4:23pm September 11th 2019 via Twitter Web App

Shaw #worldcdx Another item: can you find something 'actionable'? from https://t.co/mNwTaBlxHb - 32% actionable (80K mutations).

4:22pm September 11th 2019 via Twitter Web App

Shaw #worldcdx PM and the paradigm shift: Rx-level biomarker, reality is that most cancer medicine has little precision in it.

4:19pm September 11th 2019 via Twitter Web App

Kenna Mills Shaw (MD Andersen) #worldcdx A Guide to Biomarker-Driven Precision Medicine Clinical Trials

4:18pm September 11th 2019 via Twitter Web App

Kelly #worldcdx Shows correlative data between Oncomine Mutation Load assay correlation with FoundationOne.

3:23pm September 11th 2019 via Twitter Web App

Kelly #worldcdx Oncomine tumor mutation load assay: 2-3 slides needed, TMB harmonization via FNIH, IQNPath and QUIP groups.

3:20pm September 11th 2019 via Twitter Web App

Kelly #worldcdx Reimbursement - 160M covered in the US. Plan is to bring additional sPMAs, bringing more CDx partnerships.

3:16pm September 11th 2019 via Twitter Web App

Kelly #worldcdx sPMA expansion - Agios, Blueprint, Lilly (annc recently). EU reg Oct 2018 Korea Dec 2019 Japan Feb 2019 Austral submitted

3:13pm September 11th 2019 via Twitter Web App

Kelly #worldcdx First multi-biomarker, multi-therapy test. 4d workflow. 1-6 samples/run w/2 controls. 'Tissue-sparing NGS tech'

3:09pm September 11th 2019 via Twitter Web App

Kelly #worldcdx Although first FDA approval (June 2017) of Oncomine Dx Target Test is a beach-head, pushing toward global approvals.

3:08pm September 11th 2019 via Twitter Web App

Kelly #worldcdx Not only kits & instrumentation, but reporting. Oncomine knowledgebase reporter for annotation.

3:07pm September 11th 2019 via Twitter Web App

Kelly #worldcdx CDx is NSCLC Oncomine Dx Target test; shows large list - soild tumor (3), heme-onc (2), LBx (5), I-O (5)

3:05pm September 11th 2019 via Twitter Web App

Brian Kelly (Thermo Fisher) #worldcdx Democratization & Globalization of Next Generation Sequencing for Companion Diagnostics

3:02pm September 11th 2019 via Twitter Web App

Gustavsen #worldcdx Can tie Dx incentives to success of drug, help drive FDA-IVD preferential reimbursement

2:53pm September 11th 2019 via Twitter Web App

Gustavsen #worldcdx Dx can give superior dev support, tech adv, regulatory expertise, data connectivity, biomarker discovery

2:52pm September 11th 2019 via Twitter Web App

Gustavsen #worldcdx Brings up the balance between sensitivity and specificity: with multiplex and algorithm-based testing, no clear cut-offs

2:44pm September 11th 2019 via Twitter Web App

Gustavsen #worldcdx Challenges to newer partners - lack of regulatory experience, little commercial expertise

2:36pm September 11th 2019 via Twitter Web App

Gustavsen #worldcdx In the pipeline: 46% are targeted Ph I, 40% Ph II/II. Number of targets, amt of complexity is growing

2:35pm September 11th 2019 via Twitter Web App

Gustavsen #worldcdx CDx has been driven to a new level of complexity; pharma continues to get creative to provide a better test.

2:32pm September 11th 2019 via Twitter Web App

Gary Gustavsen (Health Advances) #worldcdx CDx Patient Leakage Mapping

2:31pm September 11th 2019 via Twitter Web App

Becker #worldcdx 6.5 / 10 ALK+ lung ca received wrong Rx due to delay in test results. 'We need to address this.'

2:25pm September 11th 2019 via Twitter Web App

Becker #worldcdx Alternative to run outside of EU. Once IVDR in-place: due to review req, will add 12 mos to approval process.

2:20pm September 11th 2019 via Twitter Web App

Becker #worldcdx Single lab, avoid using multiple LDTs to bridge to. Label extensions: A CDx may not be necessary.

2:16pm September 11th 2019 via Twitter Web App

Becker #worldcdx Sample prep, assay, informatics, results. In-house testing to IUO via Dx mfr: multiple tests refined into 1.

2:13pm September 11th 2019 via Twitter Web App

Becker #worldcdx Bridging, labeling extensions, IVDR, and global registration. "The 4 horsemen" (!) FDA sees IVD as an entire system.

2:12pm September 11th 2019 via Twitter Web App

Becker #worldcdx NSCLC for FFPE is not the same as cytology or FNA's. And stakeholders: physicians, hospitals, pharma, reference labs...

2:09pm September 11th 2019 via Twitter Web App