RT @SeraCare: Miss our latest data on #NGS and #liquidbiopsy reference materials from #TRICON? https://t.co/Tlg5ESEqeq https://t.co/Oxkyk4e…
8:02am March 25th 2016 via Twitter Web Client
RT @notSoJunkDNA: "The real cost of sequencing: scaling computation to keep pace with data generation", by @markgerstein et al https://t.co…
4:28pm March 24th 2016 via Twitter Web Client
RT @SeraCare: Inside the race to diagnose #cancer from a simple blood draw #liquidbiopsy https://t.co/1FQcqTjb1O https://t.co/STz8TuLuQl
10:29am March 21st 2016 via Twitter Web Client
RT @SeraCare: We're less than a month from #Molecular Diagnostics Europe in #Lisbon. See what we're doing! https://t.co/OejRRp5mCH https://…
8:25am March 20th 2016 via Twitter Web Client
RT @SteveStuWill: Actually, this is probably a better place to start: Why Parenting Might Not Matter https://t.co/VZOvOwbUbX @bewi https://…
RT @SeraCare: Test for #cancer, #HIV is 10,000 times more sensitive https://t.co/LFoAXfDREa https://t.co/jEAsBY1tNx
5:56pm March 11th 2016 via Twitter Web Client
RT @genome_gov: Rare disease patients share info on MyGene2 web tool to assist with gene discovery. https://t.co/5an2j1xpRE https://t.co/ht…
1:31pm March 5th 2016 via Twitter Web Client
RT @SeraCare: Comparison of #IVD industry’s top 5 trends for 2015 and 2016 https://t.co/KZL1vDFXGC https://t.co/rCxjTcUmHB
10:44am March 4th 2016 via Twitter Web Client
RT @HeidiRehm: For my talk this morning at HUGO #HGM16, slides are posted here https://t.co/kqkPrDbg5C
7:03am March 1st 2016 via Twitter Web Client
On #ThisDayInHistory in 1953, Watson and Crick discover chemical structure of DNA. Read More https://t.co/nGC2LhJZbp via @History
10:09am February 28th 2016 via Twitter Web Client
RT @GeneticsGSA: Congratulations to Leonid Kruglyak, winner of the 2016 Novitski Prize. https://t.co/WCgrtpxSqz https://t.co/08jA9Qpyuv
9:11am February 27th 2016 via Twitter Web Client
RT @AACR: The #AACR16 online itinerary planner is available now: https://t.co/yrOlDaaU0N https://t.co/gKZrnSOEdm
9:10am February 27th 2016 via Twitter Web Client
RT @kennamshaw: Roger Klein from #AMP, I think you are amazing! his public statement is a must! pushing #FDA to limit role to instrument an…
4:03pm February 25th 2016 via Twitter Web Client
Garlick: Binomial distribution: expect a 6% outliers, some low, others high (10% and 21%). Controls need to have flexiblilty #FDANGSWorkshop
4:02pm February 25th 2016 via Twitter Web Client
Garlick: 10% chart; looks like Ion Torrent has +2% AF at 10% and 20% compared to Illumina #FDANGSWorkshop
4:00pm February 25th 2016 via Twitter Web Client
Garlick:Background is PGP GM24385, measured value 18% and 10.3% by platform (ILMN or Ion Torrent). 1200 datapts/plot #FDANGSWorkshop
Garlick: Ability to trend data, challenge LOD, can test this. Did an inter-laboratory study, 4 SNVs, 4 indels, 18 SNVs #FDANGSWorkshop
3:59pm February 25th 2016 via Twitter Web Client
Russell Garlick (SeraCare Life Sciences) Doing QC standards, reference materials. Pt samples is the internal ctrl #FDANGSWorkshop
3:57pm February 25th 2016 via Twitter Web Client
Klein: Interpretation is a considerable medical judgement #FDANGSWorkshop
3:56pm February 25th 2016 via Twitter Web Client
Klein: Intrinsic properties of the smpl- CNV, aneuploidy. Complex variables require 'considerable medical judgement' #FDANGSWorkshop
Klein: An 'obsolete CDx approach'. Should be the job of the clinician. Professional, medical practice. Mfrs accurate calling #FDANGSWorkshop
3:55pm February 25th 2016 via Twitter Web Client
Klein:Instruments, reagents, informatics should be the focus, a representative sample of matrices and variants #FDANGSWorkshop
3:54pm February 25th 2016 via Twitter Web Client
Roger Klein (AMP) Sees the need for 'more appropriate regulatory pathways. FDA's approach to CDx may not be compatible w/NGS #FDANGSWorkshop
3:53pm February 25th 2016 via Twitter Web Client
Sninsky: Also recommended cloud-based analysis for community evaluation. Concordance between bioinf pipelines #FDANGSWorkshop
3:51pm February 25th 2016 via Twitter Web Client
Sninsky: Clinical-grade and research-grade NGS tests are different. High-quality databases (like CFTR) needed #FDANGSWorkshop
3:50pm February 25th 2016 via Twitter Web Client
Sninsky: cfDNA monitoring test for donated organ injury. List of rec's: select representative var's, w/boundary properties. #FDANGSWorkshop
3:49pm February 25th 2016 via Twitter Web Client
Sninsky: Serve 2.5K heart xplants/year. AlloMap product aids ID stable allograft fn. FDA cleared test #FDANGSWorkshop
3:48pm February 25th 2016 via Twitter Web Client
John Sninsky (CareDx): Organ transplant at higher risk for de novo cancer risk, higher than general population #FDANGSWorkshop
3:47pm February 25th 2016 via Twitter Web Client
Willey: Opt conditions: 50K copies, 1K amplicons sequenced; LOD 0.4% assuming 200 mut copies, 50K WT copies, 1000x depth #FDANGSWorkshop
3:46pm February 25th 2016 via Twitter Web Client
Willey: Shows sequencing depth and CV measurement dependency; 'CV should be estimated for each var fraction' #FDANGSWorkshop
3:44pm February 25th 2016 via Twitter Web Client
Willey: Shows data between error rate of native and 'internal standard', sees nice alignment #FDANGSWorkshop
3:43pm February 25th 2016 via Twitter Web Client
Willey: Determination of confidence; 'inadequate loading at each step indep increases measurement imprecision' #FDANGSWorkshop
3:42pm February 25th 2016 via Twitter Web Client
James Willey (Univ Toledo) Using synthetic controls - 3 perf characteristics '15 ref https://t.co/yUCyNunhVP #FDANGSWorkshop
3:41pm February 25th 2016 via Twitter Web Client
Aisner: No such thing as 'sample-in, answer-out' type system. Professional involvement needed #FDANGSWorkshop
3:35pm February 25th 2016 via Twitter Web Client
Aisner: An EGFR example with qPCR: where signal at Ct 34, out of range, pt is responding to Rx #FDANGSWorkshop
Aisner: Beware that the test is not more impt than the biology. #FDANGSWorkshop
3:34pm February 25th 2016 via Twitter Web Client
Open comment session: Dara Aisner (U CO): Need for ongoing QC, need to have flexibility to 'act upon ID'd weaknesses' #FDANGSWorkshop
3:33pm February 25th 2016 via Twitter Web Client
Dickson: Pts may prefer more sens over specificity; clinicians will collect the data, and better understand #FDANGSWorkshop
3:02pm February 25th 2016 via Twitter Web Client
Dickson: NGS w/more sens - many more pts will respond. Pt 'clinical FP': won't respond for any reason - will worsen #FDANGSWorkshop
Q:(Yve K from SeraCare) KRAS and CDx of 2 tests; 1-5% But NGS may be 5%. It says 'Qualitative' via the FDA #FDANGSWorkshop
3:01pm February 25th 2016 via Twitter Web Client
Kruez: "Do it upfront, and do it all" (i.e. testing). But extensive tests takes add'l time. #FDANGSWorkshop
2:58pm February 25th 2016 via Twitter Web Client
Sklar: Larger panels may have a use for validation purposes (pathways) so validation doesn't have to happen twice #FDANGSWorkshop
2:57pm February 25th 2016 via Twitter Web Client
Kulkarni: Can find driver mutations in normal individuals. Vendors need to use a lot of caution #FDANGSWorkshop
2:55pm February 25th 2016 via Twitter Web Client
Kulkarni: Agrees there's an arms race of having more. Reminds the audience that lab people see data, not patients #FDANGSWorkshop
2:54pm February 25th 2016 via Twitter Web Client
Dickson: There is a trend toward more mutations; physicians may think on a reductionist way. #FDANGSWorkshop
2:53pm February 25th 2016 via Twitter Web Client
Sklar: Great pressure on speed and brevity; but need to explain to provide info to outside stakeholders #FDANGSWorkshop
2:49pm February 25th 2016 via Twitter Web Client
Sklar: Gets back to validation efforts by Mfrs. Reporting: need to be a bit more explicit on what it means, explaining #FDANGSWorkshop
Blumenthal: Many resources spent on labeling accuracy, truthful promotion, very tricky. And for a device label? #FDANGSWorkshop
2:47pm February 25th 2016 via Twitter Web Client
Kreuz: Who is the expert with a report? How can the pt be assured of competence? #FDANGSWorkshop
2:46pm February 25th 2016 via Twitter Web Client
Q:How to truthfully, accurately provide disclaimers in labeling? #FDANGSWorkshop
2:44pm February 25th 2016 via Twitter Web Client
