Vincent Plagnol (Inivata UK) Clinical impact of a high-sensitivity ctDNA assay ana analytics for low freq mutations #MDxEU17

6:30am April 11th 2017 via Hootsuite

Palmer: EGFR down to 0.05% others at 0.5% (T790M, Ex 19 del). Cp to Roche on FFPE, not 100% identical (due to different targets) #MDxEU17

5:42am April 11th 2017 via Hootsuite

Palmer: Their tech for sensitivity is 0.05% to 0.5%. Have FFPE assay kits (with validated sens) and applied to cfDNA #MDxEU17

5:41am April 11th 2017 via Hootsuite

Palmer: pi-codes can be individually assayed then blended for readout. Can multiplex 40 individual PCRs. #MDxEU17

5:39am April 11th 2017 via Hootsuite

Palmer: 50 um discs have about 16K unique barcodes. discs have either probes or immunoassays. SA-PE fluor. Biotinylated amplicons #MDxEU17

5:37am April 11th 2017 via Hootsuite

Palmer: Presence in Taiwan, mfg in China, also south SF CA. a circular 50um silicon ring, with an optical barcode on the chip#MDxEU17

5:36am April 11th 2017 via Hootsuite

Stuart Palmer (PlexBio Taiwan): Multiplex assay on liquid biopsy: practical approach for CDx by nCode Technology #MDxEU17

5:35am April 11th 2017 via Hootsuite

Eccleston: Have plans for testing in the us 2019-2021, sample prospectively collected now. #MDxEU17

5:34am April 11th 2017 via Hootsuite

Eccleston: Their CE mark, reduces unncec. colonoscopies by 20%, detects >90% CRC. Repro studies cp manual to automated #MDxEU17

5:32am April 11th 2017 via Hootsuite

Eccleston: Via stool, ID false-pos FIT test. 95% with positive FIT do not have CRC, all get colonoscopy. #MDxEU17

5:26am April 11th 2017 via Hootsuite

Eccleston: Screening in Copenhagen - 30K prospective, longitudinal. Triage test - Me-Nuc and total Nuc (methylated, and total) #MDxEU17

5:25am April 11th 2017 via Hootsuite

Eccleston: Only 10uL plasma needed, five types of nucleosome types captured and detected. Five clinical trials ongoing #MDxEU17

5:24am April 11th 2017 via Hootsuite

Mark Ecleston (Volition, Belgium): Tu.Q triage colorectal cancer screening test #MDxEU17 Uses simple ELISA technology (capture, 2nd Ab det)

5:23am April 11th 2017 via Hootsuite

Santhanam: Shows Lab Cerba data - clear Z-score differentiation between positive and negatives. Shows multi-analyte data (all 3) #MDxEU17

5:16am April 11th 2017 via Hootsuite

Santhanam: Shows results courtesy of UK NEQAS - three labs, one able to get to 1%; two others at 4%. #MDxEU17

5:14am April 11th 2017 via Hootsuite

Santhanam: For validation/EQA, can you send to many labs? Broad range sample types; working on matched genotypes. cGMP batch rcrd #MDxEU17

5:13am April 11th 2017 via Hootsuite

Santhanam: Offer a linearity panel (8%/4%/2%/1%) shows LOD data for two platforms - MPSS around 3-4%; another provider at 2-4% #MDxEU17

5:12am April 11th 2017 via Hootsuite

Santhanam: Like a dashboard in a car, how can you drive without feedback? At dev stage, confirming known fetal fractions #MDxEU17

5:11am April 11th 2017 via Hootsuite

Santhanam: Thus treated like a patient sample, multiple approaches can be tried out for dev, for validation can perform as designed #MDxEU17

5:10am April 11th 2017 via Hootsuite

Ram Santhanam: Product is trisomic cell lines, fragmented via sonication, encapsulated and blended into synthetic plasma. #MDxEU17

5:09am April 11th 2017 via Hootsuite

Santhanam: SeraCare also produces software to assist in tracking data. https://t.co/ze2LnyXTSx #MDxEU17

5:09am April 11th 2017 via Hootsuite

Santhanam: Shows var via BioAnalyzer traces of sample prep step. Highly multiplexed assays require multiplexed ref materials #MDxEU17

5:08am April 11th 2017 via Hootsuite

Santhanam: How to move to production; how to get to multi-site comparisons. Shows '15 fig from https://t.co/cun2oK1aG2 Error to 11% #MDxEU17

5:07am April 11th 2017 via Hootsuite

Santhanam: About 80% of assays worldwide use SeraCare materials. Challenges include need to develop assays quickly. How to validate #MDxEU17

5:05am April 11th 2017 via Hootsuite

Santhanam: 30y company history, background in infectious disease. '80s began w/the first seroconversion panel. #MDxEU17

5:04am April 11th 2017 via Hootsuite

Santhanam: Going from biological challenges, now how to make you more successful for assay development, monitoring #MDxEU17

5:03am April 11th 2017 via Hootsuite

Ram Santhanam (SeraCare MA): Expediting NIPT assay development, validation and routine monitoring #MDxEU17

5:02am April 11th 2017 via Hootsuite

Dieguez: Limitations - no ubiquitious biomarker; cells not phenotype indep. Goals of their development: size-based, non-destructive #MDxEU17

4:58am April 11th 2017 via Hootsuite

Dieguez: EMT and poor prognosis - shows several ref's. 2d test, about 450€ per test, needs trained personnel. #MDxEU17

4:56am April 11th 2017 via Hootsuite

Dieguez: Successful but EMT de-differentiation and re-differentiate to form a solid tumor. Thus EpCAM not reliable #MDxEU17

4:55am April 11th 2017 via Hootsuite

Dieguez: CellSearch cutoff is >=5 /7.5mL blood (mBC and mPC); >=3/7.5mL for mCRC. If increases - pt is progressing. #MDxEU17

4:53am April 11th 2017 via Hootsuite

Dieguez: CellSearch (recently sold to Menarini), 7.5mL incubated w/EpCAM Ab, use cytokeratin, DAPI for nucleus, CD45 for WBC #MDxEU17

4:52am April 11th 2017 via Hootsuite

Dieguez: Can see markers of origin and markers of mutation in the same cell; of course rarity a challenge. #MDxEU17

4:51am April 11th 2017 via Hootsuite

Dieguez: Monitoring progression - believe that CTCs have several advantages: living and can proliferate them 'if you are lucky' #MDxEU17

4:50am April 11th 2017 via Hootsuite

Dieguez: In Braga (northern Portugal), gov of Spain and Portugal. Have 40 PI's. Started in '05, '14 new space. 100M € building. #MDxEU17

4:47am April 11th 2017 via Hootsuite

Lorena Dieguez (Iberian Nanotech Lab, PT) Microfluidic isolation of cancer cells from body fluids for early and non-invasive Dx #MDxEU17

4:43am April 11th 2017 via Hootsuite

Q: Is 1:100K the detection rate? Patel: Raw error. Analytical sens is 1:10K, also context dependent #MDxEU17

4:43am April 11th 2017 via Hootsuite

Patel: #MDxEU17 (FYI: commercialized via company called TwinStrand - GenomeWeb https://t.co/3vqelOzh5u ) requires high conversion efficiency

4:40am April 11th 2017 via Hootsuite

Patel: Deamination causes C-U mutations; oxidation of guanine forms 9-oxo-guanine G-T '12 PNAS duplex https://t.co/jcOiN1w84k #MDxEU17

4:39am April 11th 2017 via Hootsuite

Patel: Technical challenges: Shows interesting bar chart from this '15 ref https://t.co/bWogfxmXUy of the need for broad coverage #MDxEU17

4:37am April 11th 2017 via Hootsuite

Patel: Shows RECIST criteria of tumor burden decline in responders, increase w/ non-responders. #MDxEU17

4:35am April 11th 2017 via Hootsuite

Patel: Faster ctDNA drop in cp to CEA observed. I-O response: 2 pts; responders showing KRAS Q61R drop; non-resp, PIK3CA rises #MDxEU17

4:34am April 11th 2017 via Hootsuite

Patel: 84 y/o F w/rectal ca metastatic to liver, FOLFOX and Avastin chemo w/excellent response, KRAS G12Cys ctDNA drops cp to CEA #MDxEU17

4:32am April 11th 2017 via Hootsuite

Patel: After spiking post-Rx, undetectable 50d post, follow-up 5 months post-Rx no evidence of residual disease #MDxEU17

4:30am April 11th 2017 via Hootsuite

Patel: 75yo Stg I female, adenocarcincoma of rt lung. 2.9x2.5cm tumor, KRAS G13R, showed stereotactic Rx & G13R in copies/mL #MDxEU17

4:30am April 11th 2017 via Hootsuite

Patel: Claim mean background error rate of <1 in 100K. $20 seq cost per sample. One tube, one PCR, one SPRI bead purification #MDxEU17

4:27am April 11th 2017 via Hootsuite

Patel: Sequencing both top and bottom strands; not as complex a barcoding scheme as SafeSeqS; look at molecular lineage #MDxEU17

4:26am April 11th 2017 via Hootsuite

Patel: Error-suppressed sequencing: multiplexing 60- or 70-fold; sequencing and PCR errors: bidirectional PE for NGS #MDxEU17

4:22am April 11th 2017 via Hootsuite

Patel: Compartments via droplet PCR or BEAMing. NGS-based methods use amplicons or hyb-capture/ligation #MDxEU17

4:18am April 11th 2017 via Hootsuite

Patel: Measuring ctDNA is challenging due to size; methods include mutant enrichment (COLD-PCR, LNA/PNA, ARMS) or compartments #MDxEU17

4:18am April 11th 2017 via Hootsuite