New post from Fluid Dynamics, the @SysmexInostics blog, about high concordance between tissue and liquid biopsy. Ta… https://t.co/hfw15ixGJr

10:07am September 20th 2019 via Twitter Web App

The latest post from Fluid Dynamics, a blog by @sysmexinostics highlighting >90% concordance between tissue and pla… https://t.co/AJIqHU0

1:25pm September 13th 2019 via Twitter Web App

Tirunagaru #worldcdx STEAP4 converts under tumor hypoxic conditions, goes back when not under hypoxic conditions. 5… https://t.co/i1a6AJ0NYe

3:38pm September 12th 2019 via Twitter Web App

Tirunagaru #worldcdx Drug selects for hypoxic cells, and release active agent. Can sustain EGFR pathway inhibition for up to 1w

3:37pm September 12th 2019 via Twitter Web App

Tirunagaru #worldcdx Low tolerance for exon 20 insertion mutants: highly diverse set - tyr kinase domain where inhibitor can bind.

3:34pm September 12th 2019 via Twitter Web App

Tirunagaru #worldcdx Unmet need: low eff of current TKIs for EGFR exon20 insertions due to similarity of pharmacology w/WT EGFR

3:32pm September 12th 2019 via Twitter Web App

Vijaya Tirunagaru (Rain Therapeutics) #worldcdx STEAP4 ISH Diagnostics for Tarloxotinib Activation in EGFR/HER2 Mutant Cancers

3:31pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Con't: Agios published in NEJM ADH1 tracking in plasma.

3:31pm September 12th 2019 via Twitter Web App

Q:Aware of any adaptive clin trial designs? Edelstein #worldcdx There's enough data, observational in nature, plent… https://t.co/nqP2BsgUDk

3:30pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Have a validated RT shipment shipping solution. Participates in BloodPAC, working with the FDA, AMP, pre-sub pkg for FDA

3:29pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Have a rapid custom development program, bringing in genes of interest, 3-4 months for clin trials

3:28pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Shows 100% agreement data between NGS and digital PCR BEAMing assay. Pan cancer: testing unreli… https://t.co/ym0QVe015c

3:28pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Genentech study '16 Nature Comm Spoerke et al: ESR1 freq Post-Treatment 57%. Median MAF only 0.… https://t.co/JOgg56kgGE

3:27pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx ER+ in response to aromatase inh Rx, ESR mut tissue-testing not feasible due to heterogeneity.

3:26pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Inostics focuses on Rx targets, delivering high sensitivity. Ex: ESR1 mut breast cancer.

3:25pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Hyb capture is great for broad coverage, but plenty of loss - 25-40% of molecules gone.

3:24pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx At 0.1%, only 12 molecules. 0.05% is only 6 molecules. "If you have it, don't lose it."

3:24pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx For liquid biopsies, 'every molecule is sacred'. A single 10mL blood draw, is 4-5mL plasma, 40ng DNA, or 12K GE's

3:23pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx An error-corrected workflow. Built for cfDNA. UIDs labled, ID a legitimate change vs seq error.… https://t.co/q1OjkWBFUR

3:22pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx 1% high rate of FP and FN results. Shows chart of majority of pts with mutations below 1%.

3:20pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Millions of compartments. NGS is also digital, but background mutations are common. Caution raised: FDA-AACR

3:20pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Concept: digital genomics, partitioning sample into individ. compartments, w/quantitative readout.

3:19pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Rarity of ctDNA: in blood, 55% plasma, 0.02-0.06% MAF (BEAMing and SafeSEQ sens).

3:18pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Technical challenge of ctDNA 1: half-life is short, determine what is tumor DNA vs normal. Show… https://t.co/J8ATiXlMhR

3:18pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Refractory pts - may bring into combinatorial treatment arm.

3:17pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx ctDNA clearance: plasma EGFR muts can predict outcome on osimertinib in the AURA trial. Cleared ctDNA double PFS, ORR

3:16pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx For immune checkpoint inh: 30pts, 8 progressed, 4 w/ctDNA detected: in each one, 21 weeks prior… https://t.co/BwnZtfoQwP

3:15pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Surveillance: application 3, plasma ctDNA enhances resolution of disease progression in Stg IV… https://t.co/SRSicm4KU6

3:15pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx In panc ca: two different pts, spike and disappearance of mutKRAS.

3:14pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Clovis looked at early ctDNA kinetics, monitor mut EGFR in resp to reciletinib by day 21. Declining vs increasing levels

3:13pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Case 2: ctDNA testing for rapid treatment response assessment. 2w post-Rx: predictive of response.

3:12pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Case 1: Hopkins FNA of panc ca, revealed melanoma, NRAS Q61 mut, Mekinist Rx, 40% reduction in tumor size

3:12pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx MRD - quant assay with superior LoD and high dynamic range. Surveillance - high sensitivity assays to detect relapse

3:11pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx For Rx selection at diagnosis; broader assays LoD dep on disease state. Other areas: emerging resistance.

3:10pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Clinical appl: how ctDNA can provide info - screening has value, not covered here.

3:10pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Japan PMDA approved, first liquid biopsy approval in Japan. Can bring forward assays to IDE, PM… https://t.co/JBJrKjkdHG

3:09pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Clinical evidence creation: OncoBEAM RAS equiv to tissue RAS testing. Outcome data: plasma resu… https://t.co/jtpVEX29EV

3:08pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Recent achievement - OncoBEAM RAS kit from CRC LDT to IVD, with Merck. Sped up TAT, CE mark April '16 7-10d TAT

3:08pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx Shows busy slide of publications, clinical milestones. First with anti-EGFR muts, 40% dev resis… https://t.co/cAGefK0Do1

3:07pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx 80K samples across 120 clinical trials. '08 Inostics was formed, first ctDNA CLIA-lab provider.… https://t.co/Cy5XmsWRLX

3:06pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx As hypotheses mature, can provide IVD/CDx either as a kit or as a ref lab. Labs in MD, Germany… https://t.co/DmBle1lf0l

3:05pm September 12th 2019 via Twitter Web App

Edelstein #worldcdx How a highly sensitive assay can help with a clinical trial. Started in 2011 with patient testi… https://t.co/er0NU3bgGg

3:04pm September 12th 2019 via Twitter Web App

Dan Edelstein (Sysmex Inostics) #worldcdx Accurate Plasma Biomarker Detection for Clinical Trials & Clinical Practi… https://t.co/UGhM1e

3:03pm September 12th 2019 via Twitter Web App

Q: Sensitivity driving from 20 copies down to 2-5 copies/mL? Pestano #worldcdx May not be the wisest thing to do. C… https://t.co/aGrDkWs35y

12:34pm September 12th 2019 via Twitter Web App

Pestano #worldcdx It's an LDT PMA; all in-house, defined equipment, protocols.

12:32pm September 12th 2019 via Twitter Web App

Q:Adv of ssPMA? Pestano #worldcdx FMI is one. Biodesix does not have a dist test; very different model. ILR's not needed; serial # inst.

12:31pm September 12th 2019 via Twitter Web App

Pestano #worldcdx GeneStrat 52: ssPMA, rapid TAT, NSCLC. Shows very good concordance bet ddPCR and NGS MAF

12:27pm September 12th 2019 via Twitter Web App

Pestano #worldcdx Panc cancer, AML, HNSCC studies ongoing with Veristrat.

12:23pm September 12th 2019 via Twitter Web App

Pestano #worldcdx Illus MALDI test w/AVEO, multi-variate proteomic sig, shows treatment diff ESMO '14 data

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

Pestano #worldcdx 13485 compliant; shows busy slide of CDx co-dev plan. Phase-gated, 3 FDA pre-subs.

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