Companion Diagnostics

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Flow Cytometry–based Companion Diagnostics (CDx) Solutions

Built on a foundation of excellence and immunological expertise, BD Biosciences is committed to unlocking the potential of flow cytometry–based CDx solutions. With increasingly complex target and drug combinations, cutting-edge therapies require cutting-edge diagnostic solutions. Long established as the gold standard for immunophenotypic analysis¹, flow cytometry provides the detailed proteomic analysis of multiple cell types, maximizing the amount of information gathered from rare cells² that can influence critical decisions. From discovery to commercial launch, a collaborative partnership with BD provides the flexible, end-to-end solutions needed to rapidly advance your scientific breakthroughs.

Workflow

Comprehensive CDx Development Process

BD has an experienced team and leading flow cytometry technologies to support comprehensive CDx co-development from discovery to global commercialization. We offer the flexibility to collaborate at any stage of therapeutic, biomarker or diagnostic development.

Instrumentation

Reagents

Sample Processing

Commercialization

Built on a foundation of excellence, experience and expertise, the BD FACSLyric™ Flow Cytometry System (RUO/ IVD) provides the standardization and sensitivity necessary for next-generation clinical trial assays and companion diagnostics.

By combining automation, simplicity and speed, BD is creating a new, streamlined workflow to meet increasingly complex therapeutic options.

With U.S FDA 21 CFR Part 11–compliant capabilities, cutting-edge reagents and unparalleled support, BD is the partner of choice for flow cytometric–based companion diagnostics.

The Power of the BD FACSLyric™ Flow Cytometer:

4-, 6-, 8-, 10- and 12-color configurations. Onsite upgradeable to adapt to your lab’s changing needs
Up to 3 lasers—blue, red and violet—12 fluorescence channels and 14 parameters
35,000 events per second maximum acquisition rate; no limit on number of events acquired
Automated single-tube QC with BD^® CS&T Beads
Fluorescence compensation required only every 60 days, improving efficiency and productivity
21 different loading options: plates or tubes; built-in flexibility with the BD FACS™ Universal Loader
Powered by the BD FACSuite™ Acquisition and Analysis Application, whose password protection, audit trail, electronic signatures and IQ/OQ procedures assist in supporting U.S. FDA 21 CFR Part 11 compliance
The BD FACSLink™ Laboratory Information System (LIS) Interface and BD Assurity Linc™ Remote Systems Management Software streamline your workflow and help improve productivity through seamless integration

BD offers custom and catalog panels in liquid, dried and lyophilized formats to minimize the errors and time associated with manual cocktailing of reagents. Dried and lyophilized formats increase reagent stability and significantly enhance consistency and assay performance. These offerings include contract manufacturing of pre-aliquoted, performance-optimized multicolor panels for flow cytometry in a dried down, ready-to-use format. The dried multicolor panels reduce inter-experiment variability and come with long shelf lives making them ideal choices for multisite and longitudinal studies.

	Liquid Cocktails	BD Horizon™ Dri Chroma	BD Horizon™ Lyo
Product Offering	Liquid Cocktail	Preformulated Dried Cocktail	Preformulated Lyophilized/ Freeze-dried Cocktail
Capability	Standard dyes + up to 1 BD Horizon Brilliant™ Dye per vial	Standard dyes + up to 5 BD Horizon Brilliant™Dyes per tube	Standard dyes + up to 1 BD Horizon Brilliant™ Dye per tube
Packaging	Vials: 25–100 tests per vial	Tubes (no caps)	Tubes (with caps), plates, microtubes, multi-test vials
Stability	Stability varies based on cocktail composition	12 months	18 months
Min. Order Qty	150 tests	250 tests	<200 tests 20 plates (96-well plates)
Storage Conditions	2–8 °C	20–25 °C	20–25 °C

BD Horizon™ Dri Chroma Pane l

BD Horizon™ Lyo Cocktails

Tumor Dissociation by TTDR

Solid Tumor Biopsy Workflow

BD has an experienced team and the leading flow cytometry technologies to support comprehensive CDx co-development from discovery to global commercialization.

We offer the flexibility to engage with partners at any stage of therapeutic, biomarker or diagnostic development.

The BD Horizon™ Dri Tumor and Tissue Dissociation Reagent (TTDR) offers gentle and effective dissociation with superior epitope preservation. TTDR maximizes cell yields, while minimizing cell death, which allows effective dissociation of a variety of tumor types to enable single-cell studies.

Tumor types evaluated by BD or external investigators include lung³, colon³, and melanoma.

View a full list of surface markers

Enabling analysis of solid tumor biopsies by flow cytometry

BD products have been used for analyzing solid tumor biopsies using flow cytometry.

See publications related to this workflow

The PD-1 expression balance between effector and regulatory T cells predicts the clinical efficacy of PD-1 blockade therapies

STAR Protocol

Isolation of tumor-infiltrating lymphocytes from preserved human tumor tissue specimens for downstream characterization

BD Biosciences is an industry leader in flow cytometry with over 45 years of flow cytometry expertise and 20,000+ catalog reagents used in 190 countries across the globe. With over sixty million IVD tests sold worldwide, we have the global infrastructure and support teams needed to successfully create, develop and launch a companion diagnostic test. Our dedicated CDx team will work closely with you throughout the entire process to ensure a successful day one launch.

BD has extensive global reach and IVD regulatory experience to support your CDx program.