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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.

 
Companion Diagnostics Workflow
performance1

*High sensitivity and specificity demonstrated via IVD assays cleared on BD FACSLyric™ Flow Cytometer.

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

 


Using the assay portability feature, a user-defined assay was ported across three different BD FACSLyric™ Flow Cytometers. The results above show the highly reproducible and accurate performance of the BD FACSLyric™ System between instruments.

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 Panel

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


Graphical depiction demonstrating majority markers measured had preserved epitopes measured by MFI and SI, showing less than 0–30% change following dissociation.

Enabling analysis of solid tumor biopsies by flow cytometry

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.

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

 


Using the assay portability feature, a user-defined assay was ported across three different BD FACSLyric™ Flow Cytometers. The results above show the highly reproducible and accurate performance of the BD FACSLyric™ System between instruments.

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 Panel

BD Horizon™ Lyo Cocktails

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.

Why BD?

BD is your dependable partner for CDx

 

BD is an excellent partner for CDx development based on acknowledged diagnostic expertise:

 

  • Deep commercial experience with flow cytometry
  • Dedicated CDx team
  • Global install base
  • Regulatory compliance (IVD/IVDR)
  • End-to-end solutions

 

Global Diagnostics Expertise and Footprint

Global Diagnostics Footprint

Contact Us


Our dedicated CDx team provides solutions ranging from assay development to CDx commercialization. If you have any questions or would like to learn more about how BD can help, please provide your contact information and someone from our team will personally reach out to you. 

 

 

*Required fields

References

  1. Rane AS, Rutkauskaite J, DeMello A, Stavrakis S. High-throughput multi-parametric imaging flow cytometry. Chem. 2017. 3(4):588-602.
  2. Roshal M, Flores-Montero JA, Gao Q, Koeber M, Wardrope J. et al. MRD detection in multiple myeloma: comparison between MSKCC 10-color single-tube and EuroFlow 8-color 2-tube methods. Blood Adv. 2017. 1(12):728-732. https://doi.org/10.1182/bloodadvances.2016003715
  3. Kumagai S, Togashi Y, Kamada T, Sugiyama E, Nishinakamura H et al. The PD-1 expression balance between effector and regulatory T cells predicts the clinical efficacy of Pd-1 blockade therapies. Nature Immunology. 2020. 21, 1346-1358

  

The BD FACSLyric™ Flow Cytometer and BD FACSDuet™ Sample Preparation System are Class 1 Laser Products.

The BD FACSLyric™ Flow Cytometer is for In Vitro Diagnostic Use with BD FACSuite™ Clinical Application for up to six colors.

The BD FACSLyric™ Flow Cytometer is for Research Use Only with BD FACSuite™ Application for up to 12 colors. Not for use in diagnostic or therapeutic procedures.

The BD FACSDuet™ Sample Preparation System is for In Vitro Diagnostic Use. Sample preparation for user defined protocols and cocktailing functions are for Research Use Only.
Not for use in diagnostic or therapeutic procedures.

BD Vacutainer® Tubes are for In Vitro Diagnostic Use.

Other BD products included in this document are for Research Use Only. Not for use in diagnostic or therapeutic procedures.