title: Considerations in the development of circulating tumor cell technology for clinical use.
abstract: This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC) technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker development-analytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA) and the US National Cancer Institute (NCI).
authors: New Enterprise Associates, Menlo Park, CA 94025, USA. dparkinson@nea.com
authors: David R
authors: DR
authors: Parkinson
authors: Nicholas
authors: N
authors: Dracopoli
authors: Brenda Gumbs
authors: BG
authors: Petty
authors: Carolyn
authors: C
authors: Compton
authors: Massimo
authors: M
authors: Cristofanilli
authors: Albert
authors: A
authors: Deisseroth
authors: Daniel F
authors: DF
authors: Hayes
authors: Gordon
authors: G
authors: Kapke
authors: Prasanna
authors: P
authors: Kumar
authors: Jerry Sh
authors: JSh
authors: Lee
authors: Minetta C
authors: MC
authors: Liu
authors: Robert
authors: R
authors: McCormack
authors: Stanislaw
authors: S
authors: Mikulski
authors: Larry
authors: L
authors: Nagahara
authors: Klaus
authors: K
authors: Pantel
authors: Sonia
authors: S
authors: Pearson-White
authors: Elizabeth A
authors: EA
authors: Punnoose
authors: Lori T
authors: LT
authors: Roadcap
authors: Andrew E
authors: AE
authors: Schade
authors: Howard I
authors: HI
authors: Scher
authors: Caroline C
authors: CC
authors: Sigman
authors: Gary J
authors: GJ
authors: Kelloff
mesh_terms: D014408:Biomarkers, Tumor; D006801:Humans; D009360:Neoplastic Cells, Circulating
chemical_list: D014408:Biomarkers, Tumor