Matthew McManus (Asuragen) Overcoming the technical challenges of genetics #PMWC17

7:10pm January 24th 2017 via Twitter Web Client

Great to meet @laosaal here at #PMWC16 SAGA Diagnostics in Sweden will be (another) ctDNA company to watch.

7:10pm January 24th 2017 via Twitter Web Client

Collins: For KRAS, strong signal. Drug rescue has political implications as well 'what went wrong with the pharma study' #PMWC17

6:30pm January 24th 2017 via Twitter Web Client

Q:Retrospective examination? Lai: We have but not popular, unless the drug failed. Most drug co's don't look at it again. #PMWC17

6:28pm January 24th 2017 via Twitter Web Client

Q: Collection of samples used for discovery? Lai: For secondary validation, optimization, other populations #PMWC17

6:27pm January 24th 2017 via Twitter Web Client

Lai: We get biomarkers all the time; but many who aspire to CDx don't have any idea what it involves #PMWC17

6:21pm January 24th 2017 via Twitter Web Client

Q: Appl of machine learning for Dx/Rx effectiveness? Lai: Has been used in discovery, but by the time to Dx too late. $ gets in way #PMWC17

6:20pm January 24th 2017 via Twitter Web Client

Collins: It's David and Goliath; Dx adds risk and loss of control to Pharma. #PMWC17

6:18pm January 24th 2017 via Twitter Web Client

Collins: Evidence generation on effectiveness of testing needs to be started early #PMWC17

6:16pm January 24th 2017 via Twitter Web Client

Collins: Regulatory challenges have never been greater for a global launch; start early, get support from pharma for legwork #PMWC17

6:15pm January 24th 2017 via Twitter Web Client

Collins: Country-spec guidelines; China for example wants to be like the FDA, but have their own 'nominated labs' #PMWC17

6:15pm January 24th 2017 via Twitter Web Client

RT @GuneetWalia: Eltoukhy claims @GuardantHealth is #LiquidBiopsy leader w >30K pts sequenced in 38 countries, Digital Sequencing 0.01% s

6:12pm January 24th 2017 via Twitter Web Client

RT @atulbutte: Wow, what a list! All the liquid biopsy companies out there… nice list presented at #PMWC17 https://t.co/MDvX27CWjL

6:11pm January 24th 2017 via Twitter Web Client

Collins: A Dx company may come in only 9 mos before launch; engagement as early as possible highly desired. #PMWC17

6:11pm January 24th 2017 via Twitter Web Client

Collins: Alliance management is critical - the right people in the right roles. Rx prepares for commercial launch for years. #PMWC17

6:09pm January 24th 2017 via Twitter Web Client

Collins: Dx companies may not have many project managers; but pharma has a lot of it. 'Good project mgmt is essential' #PMWC17

6:08pm January 24th 2017 via Twitter Web Client

John Collins (Premaitha) How to make Rx-Dx alliances work #PMWC17

6:07pm January 24th 2017 via Twitter Web Client

Eltuokhy: Lunar-I, MRD; Lunar-II, high-risk early detection. G360 for targeted Rx, G Universal for clin trial enrollment #PMWC17

5:56pm January 24th 2017 via Twitter Web Client

Eltuokhy: AZ, Pfizer, Merck, Serono partners. Pre- and post-cancer monitoring: need high specificity. Lunar program for early det #PMWC17

5:55pm January 24th 2017 via Twitter Web Client

Eltuokhy: 35 pharma partners; create product for faster enrollment? Announced 500 gene Guardant Omni #PMWC17

5:54pm January 24th 2017 via Twitter Web Client

Eltuokhy: 2K analytical samples, 4 LDT upgrades, 12+ blinded clinical studies. 500 pts in clin utility studies #PMWC17

5:52pm January 24th 2017 via Twitter Web Client

Eltuokhy: >2k pts in clinical utility studies; assay for all four var types. Significant investment in clin utility #PMWC17

5:51pm January 24th 2017 via Twitter Web Client

Eltuokhy: 73-gene panel, taking it to the FDA 'as we speak', >90% of cancer ctrs using G360; >3000 ordering oncologists #PMWC17

5:50pm January 24th 2017 via Twitter Web Client

Eltuokhy: At 100K pts, using both genetic and epigenetic markers in blood. #PMWC17

5:49pm January 24th 2017 via Twitter Web Client

Eltuokhy: Claim 0.01% detection sensitivity, down to a single molecule. Also claims 10x reduction in assay cost #PMWC17

5:48pm January 24th 2017 via Twitter Web Client

Eltuokhy: Being able to reduce noise for SNVs, CNVs via their digital seq approach. #PMWC17

5:46pm January 24th 2017 via Twitter Web Client

Eltuokhy: Analogy to wired to wireless phone system - exponential speed-up in cancer treatment progress #PMWC17

5:46pm January 24th 2017 via Twitter Web Client

Eltuokhy: They have >80% market share, have analyzed >30K pts, Recurrence, early det, MRD #PMWC17

5:45pm January 24th 2017 via Twitter Web Client

Helmy Eltuokhy (Guardant Health) Liquid biopsy applications and new horizons #PMWC17

5:42pm January 24th 2017 via Twitter Web Client

Koch: One of the best applications is enrollment into clinical trials. #PMWC17

5:41pm January 24th 2017 via Twitter Web Client

Koch: Complementarity of PCR to NGS. Full advocate of tissue profiling. Rx response/MRD monitoring #PMWC17

5:41pm January 24th 2017 via Twitter Web Client

Koch: Spent almost same amt of time/effort for othogonal validation method (here NGS). Even more impt for clin outcome #PMWC17

5:40pm January 24th 2017 via Twitter Web Client

Koch: Intended use? LOD vs LOQ. Standarizing metrics (mutant copies/mL). Standards needed across technology platform #PMWC17

5:39pm January 24th 2017 via Twitter Web Client

Koch: Now looking at fusion RNA via cobas assay, can detect down to 12 copies. #PMWC17

5:38pm January 24th 2017 via Twitter Web Client

Walter Koch (Roche) Bringing liquid biopsy to the clinic: overcoming fundamental challenges #PMWC17

5:37pm January 24th 2017 via Twitter Web Client

Aisner: And then the threshold - what's a high and low? Can create materials '10 muts / megabase'; but xlate to clin meaningful? #PMWC17

5:30pm January 24th 2017 via Twitter Web Client

Aisner: Biology - what's the threshold? Constrained by technology/method. #PMWC17

5:29pm January 24th 2017 via Twitter Web Client

Q: Tumor burden for validating? Tsongalis:May get to qualitative result not good enough. Problem:heterogeneity #PMWC17

5:28pm January 24th 2017 via Twitter Web Client

Aisner: The costs are becoming higher and higher, limiting democratization; but systems easier to plug-and-play #PMWC17

5:27pm January 24th 2017 via Twitter Web Client

Will this limit NGS adoption? Tsongalis:PT and validations in old way is impossible. CAP moving away; a 'procedural validation' #PMWC17

5:26pm January 24th 2017 via Twitter Web Client

Q:W/o positive samples, how to validate? Aisner: Sample swaps. Ex NTRK fusions, you find them. #PMWC17

5:24pm January 24th 2017 via Twitter Web Client

Aisner: It's all about having this ASAP. TAT is typically 7 business days. #PMWC17

5:22pm January 24th 2017 via Twitter Web Client

Tsongalis: We keep pushing as what's not actionable today may be so next month or year. Remining is impt, accurate all over. #PMWC17

5:21pm January 24th 2017 via Twitter Web Client

Not aligned reads? Aisner: They BLAST all reads, and often soft-clipping was too aggressive. Indels of particular interest #PMWC17

5:20pm January 24th 2017 via Twitter Web Client

(Jim): Cancer moonshot - feels there has made some progress. Asiner: In CO, instrumentation works differently at altitude. #PMWC17

5:18pm January 24th 2017 via Twitter Web Client

Aisner: CAP attempted to do this, but due to scarcity of materials, didn't get going due to lack of participation #PMWC17

5:15pm January 24th 2017 via Twitter Web Client

Q: Datasharing to give? Why for free? Tsongalis: We do this now, on an individual basis. #PMWC17

5:14pm January 24th 2017 via Twitter Web Client

Tsongalis: The big thing is clinical usefulness. <100 genes w/clinically actionable variants. But he's cautious. #PMWC17

5:13pm January 24th 2017 via Twitter Web Client

Aisner: Data is forthcoming, but guidance would be invaluable for handling for ctDNA. #PMWC17

5:12pm January 24th 2017 via Twitter Web Client

Aisner: Pre-analytic variables more complex for ctDNA. Not a lot of understanding how to handle. Time? Temp? Tube? Spins? #PMWC17

5:11pm January 24th 2017 via Twitter Web Client