Pestano #worldcdx Will talk about VeriStrat. 3 labs - Boulder, Seattle, De Soto KS. 4 on-market tests for lung cancer.
12:10pm September 12th 2019 via Twitter Web App
Gary Pestano (Biodesix) #worldcdx Development of a blood-based clinical diagnostic for a ssPMA
12:08pm September 12th 2019 via Twitter Web App
Q: Can it be prospective? Leiman #worldcdx Can be both. Started retrospective, now prospective w/clinical trials ongoing
Leiman #worldcdx How do materials perform across labs and platforms?
12:03pm September 12th 2019 via Twitter Web App
Leiman #worldcdx Notes companies committed - including @SysmexInostics - and requested ref materials. Lilly, AZ, BMS, Illumina, Pfizer.
12:00pm September 12th 2019 via Twitter Web App
Leiman #worldcdx Manuscript going to Clin Cancer Res, will publish white-paper and AACR symposium.
11:58am September 12th 2019 via Twitter Web App
Leiman #worldcdx Analytical validation protocols: a complete set of generic protocols to provide test devs a core b… https://t.co/DoRdLfca4L
11:57am September 12th 2019 via Twitter Web App
Leiman #worldcdx Data commons: majority is cfDNA, also lists cfRNA, exosomes etc. Pre-analytical WG: leaders from Novartis, Illumina, MSKCC.
11:53am September 12th 2019 via Twitter Web App
Leiman #worldcdx ID'd 11 required pre-analytic attributes essential for studies. Analytical validation working grou… https://t.co/FFdMD9k9XA
11:51am September 12th 2019 via Twitter Web App
Leiman #worldcdx Started 3 clinical trials (breast, prostate, lung), reimb working group. Data commons est'd, SOP w/curation, processing
11:48am September 12th 2019 via Twitter Web App
Leiman #worldcdx Shows slide of member list, https://t.co/ejxE4XCCUQ Originally part of the Cancer Moonshot. Met w/FDA Aug '16
11:46am September 12th 2019 via Twitter Web App
Leiman #worldcdx Meet 4x/year, 35 members, recognizes data sharing / evidence generation as fundamental req'ments
11:45am September 12th 2019 via Twitter Web App
Lauren Leiman (BloodPAC) #worldcdx Standardization and validation: the challenges associated with establishing acc… https://t.co/JG6rc9hF9u
11:43am September 12th 2019 via Twitter Web App
Q: Physician limitations on using an LDT? Weiss #worldcdx They can choose - FDA doesn't regulate medicine
9:20am September 12th 2019 via Twitter Web App
Q: Thoughts on plasma? Weiss #worldcdx They are trying to catch up. Consensus groups: rec'd situations where tissue unavailable
9:19am September 12th 2019 via Twitter Web App
Weiss #worldcdx There is pressure to offer CDx; often compelling reasons for LDT are clinical factors, complexity,… https://t.co/E4kfkjeZfD
9:17am September 12th 2019 via Twitter Web App
Weiss #worldcdx Particularly reluctant for currently monitored pts. Not practical to offer two tests during transition.
9:15am September 12th 2019 via Twitter Web App
Weiss #worldcdx BRC-ABL: CDx avail in Dec '17, a superior test. But clinicians don't want to switch; greater restrictions on spec handling
Weiss #worldcdx It may take time to commercialize CDx after FDA approval (due to competing LDTs). CDx may be out of… https://t.co/JqCpUg8sei
9:14am September 12th 2019 via Twitter Web App
Weiss #worldcdx PIK3CA: 2 LDTs offered, Sanger, NGS; RGQ PCR approved in May '19. Exclusive uptake for CDx due to sponsored testing
9:11am September 12th 2019 via Twitter Web App
Weiss #worldcdx Reimbursement: payors don't care whether it is a CDx or LDT: antibody test for Her2. Codes lag-time is shorter now.
9:10am September 12th 2019 via Twitter Web App
Weiss #worldcdx CDx designed at the time of clinical trials; time to approval may be long, LDTs can be modified but CDx can't
9:04am September 12th 2019 via Twitter Web App
Weiss #worldcdx PD-L1 cutoffs: the lab is challenged with spec Ab, spec protocol, spec machine to preserve cutoffs.
9:01am September 12th 2019 via Twitter Web App
Weiss #worldcdx When precision in cutoffs req'd, CDx preferred; is a specialized control tissue req'd, available? NTRK so rare.
9:00am September 12th 2019 via Twitter Web App
Weiss #worldcdx CDx complexity: multi-analyte difficult, 'black box' algorithms virtually impossible to replicate.
8:59am September 12th 2019 via Twitter Web App
Weiss #worldcdx MMR/MSI for I-O: no approved CDx, along with NTRK fusions. CLIA-approved LDT is sufficient.
8:57am September 12th 2019 via Twitter Web App
Weiss #worldcdx Is it a CDx or LDT? FDA has 37 CDx. They offer 8, with a variety of technologies.
8:50am September 12th 2019 via Twitter Web App
Lawrence Weiss (NeoGenomics) #worldcdx Companion Diagnostics and Precision Medicine - role of NeoGenomics
8:48am September 12th 2019 via Twitter Web App
Stuart Martin (U Maryland) #worldcdx Accelerating functional analysis of patient tumor cells to reduce metastasis
8:22am September 12th 2019 via Twitter Web App
Sireci #worldcdx And you can partner outside CDx paradigm. "I know this is heresy." Medicine is moving toward preci… https://t.co/EI01DqYPJE
8:19am September 12th 2019 via Twitter Web App
Sireci #worldcdx Meet customers where they are; RNA hyb capture (ILMN), and now partnering with TMO as hyb capture doesn't 'maximize access'
8:18am September 12th 2019 via Twitter Web App
Sireci #worldcdx Can pts be ID'd and enrolled? Can resistance be anticipated? larotrectinib dev / commercialized by… https://t.co/S5Y4vy1yWY
8:14am September 12th 2019 via Twitter Web App
Anthony Sireci (LOXO Oncology) #worldcdx Their approach: is the genetic alteration a true driver? Can the medicine… https://t.co/OvmimOfOuK
8:13am September 12th 2019 via Twitter Web App
Destenaves #worldcdx In practice after approval: Pt, physician value; assay avail & reimburseemnt; clin guidelines
5:31pm September 11th 2019 via Twitter Web App
Destenaves #worldcdx Key steps of CDx: scientific understanding, Dx platform availability and utility, and regulatory acceptance
5:30pm September 11th 2019 via Twitter Web App
Destenaves #worldcdx 28 Dx linked to 6 medicines. Case study: olaparib, PARPi to increase ds-breaks. In normal cell… https://t.co/oguA8osOKt
5:26pm September 11th 2019 via Twitter Web App
Destenaves #worldcdx Shows 250K genomes analyzed (on teh way to 2M), 90% of clinical pipeline is PM; $230M invested in Dx partnerships
5:23pm September 11th 2019 via Twitter Web App
Benoit Destenaves (AstraZeneca) #worldcdx Key Considerations for Accelerating the Integration of Diagnostic Testing
5:22pm September 11th 2019 via Twitter Web App
Hasan #worldcdx Also need to file local regulatory filings. Also pre-study QC, and very hosp has different audit cr… https://t.co/pnopXw1JKY
5:06pm September 11th 2019 via Twitter Web App
Hasan #worldcdx Trial sites / CRO collection has limits on sample numbers; arduous contracting / investigator agree… https://t.co/dEqb880g5x
5:05pm September 11th 2019 via Twitter Web App
Hasan #worldcdx Talking about China: NMPA has a division CMDE (ctr for medical device eval), and the HGRAC (human g… https://t.co/IdQc2puJ7w
5:01pm September 11th 2019 via Twitter Web App
Shirin Hasan (Agilent) #worldcdx There's en exponential growth of CDx, but limited infrastructure. CROs for IVD dev… https://t.co/q4uiA5yazD
5:00pm September 11th 2019 via Twitter Web App
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
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 Shows screen where clinician can easily refer to clin trial enrollment. Yet mistakes get made - righ… https://t.co/Cxec4Km0BN
4:37pm 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
