September 2019

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

Pestano #worldcdx TMO on S5 Prime platform. nodify is on LC/MS; veristrat on MS. Shows many TMO panels (6 cfDNA, 5 add'l panels), ddPCRs etc

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

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

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

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 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 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

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 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

9:15am 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 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

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 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