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BD COR™

Comprehensive capabilities. Breakthrough performance.

Overview
Assays
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Meet the BD COR™ System

Delivering efficiency, flexibility and performance to meet your laboratories' evolving molecular diagnostic needs.

Efficiency

Fully integrated specimen preanalytics via sophisticated automation
Minimal interaction required to maintain a high level of system throughput
Up to 210 sample results on the BD COR™ GX Instrument within one 8-hour shift

Performance

Modular and scalable to deliver needed throughput and overall system output
Remote monitoring with internal cameras and built-in redundancy to maximize uptime
Multiplex PCR assay design supports accurate diagnostics

Flexibility

Distinct instruments configurable to multiple system arrangements:
– BD COR™ PX Instrument to manage preanalytical sample processing
– BD COR™ GX Instrument to perform the BD Onclarity™ HPV Assay with extended genotyping
Random and continuous access
Ability to prioritize specimen work up

Accuracy

Multiplex RT PCR assay for the qualitative detection of 14 high-risk HPV types
On-demand genotyping for individual results of 16, 18, 31, 45, 51 and 52 with pooled results of 33/58, 35/39/68 and 59/56/66
E6/E7 DNA target
Utilizes human beta globin as an internal control

Extend the power of HPV testing

The BD Onclarity™ HPV Assay provides extended high-risk HPV genotyping results beyond 16 and 18, to support risk stratification and enhanced patient management

Support

Adapt

Advance HPV testing

Support risk stratification

Extended genotyping supports risk stratification and persistence monitoring to guide patient management7-11
Genotypes 16 and 18 account for 70% of invasive cancer worldwide, but the prevalence of these genotypes is declining as vaccination rates increase1-5
Genotypes 31/33/58 have a CIN3+ risk similar to genotype 18, but 51/35/39/68/59/56/66 have a much lower risk6,7
The BD Onclarity™ HPV assay reports individual results for 6 of the 14 high-risk genotypes and grouped results for the remaining 8 high-risk genotypes8
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Adapt to evolving screening guidelines

Adapt to evolving screening guidelines
In the post-vaccination era the prevalence of high-risk genotypes is changing making it crucial to identify high-risk genotypes individually9
The BD Onclarity™ HPV assay is FDA-approved for extended genotyping, offering the flexibility you need to adapt to changing clinical landscape and screening guidelines

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HPV primary
screening
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Co-testing
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Cytology primary +
ASCUS reflex

Advance HPV testing accuracy and make more informed decisions

The BD Onclarity™ HPV assay is designed to minimize the risk of false-negative results by:
Including an internal cellular control, verifying that a sample is present8
Targeting the E6/E7 region of the HPV viral genome rather than the L1 region, which can be deleted during HPV DNA integration8
The BD Onclarity™ HPV assay is designed to minimize the risk of false-positive results by lacking cross-reactivity with low-risk HPV types8
The BD Onclarity™ HPV assay with extended genotyping enables you to stratify patients according to risk10
Make more informed decisions with the extended genotyping information you need to assess each patient’s risk for confident follow-up decisions10-14

World Health Organization, Department of Reproductive Health and Research. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. 2007.
Oliver SE et al. J Infect Dis. 2017;216(5):594–603.
Drolet M et al. Lancet Infect Dis. 2015;15(5):565–580.
Garland SM et al. Clin Infect Dis. 2016;63(4):519–527.
Stoler et al. Clin Infect Dis. 2019 ;153(2) :259-265.
Schiffman M et al. Gynecol Oncol. 2015;138(3):573–578.
Schiffman M et al. Int J Cancer. 2016;139(11):2606–2615.
BD Onclarity HPV Assay US Package Insert [8089894]
Osbourne et al. Vaccine. 33(2015)201-208.
Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33.
Bonde J et al. Int J Cancer. 2019; doi:10.1002/ijc.32291.
Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–264.e7.
Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–772.
Bottari F et al. J Low Genit Tract Dis. 2019;23(1):39–42.
Perkins RB, Fuzzell LN, Lake P, McIntyre M, Nayar R, Saraiya M, Loukissas J, Felder T, Guido RS, Vadaparampil ST. Incorporating Stakeholder Feedback in Guidelines Development for the Management of Abnormal Cervical Cancer Screening Tests. J Low Genit Tract Dis. 2020 Apr;24(2):167-177. doi: 10.1097/LGT.0000000000000524. PMID: 32243312; PMCID: PMC7147423.
Gage JC, Schiffman M, Katki HA, Castle PE, Fetterman B, Wentzensen N, Poitras NE, Lorey T, Cheung LC, Kinney WK. Reassurance against future risk of precancer and cancer conferred by a negative human papillomavirus test. J Natl Cancer Inst. 2014 Jul 18;106(8):dju153. doi: 10.1093/jnci/dju153. PMID: 25038467; PMCID: PMC4111283.
Wright TC Jr, Stoler MH, Parvu V, Yanson K, Cooper C, Andrews J. Risk detection for high-grade cervical disease using Onclarity HPV extended genotyping in women, ≥21 years of age, with ASC-US or LSIL cytology. Gynecol Oncol. 2019 Aug;154(2):360-367. doi: 10.1016/j.ygyno.2019.05.012. Epub 2019 May 31. PMID: 31160073.

BD COR™ GX Instrument

Automates testing of the BD Onclarity™ HPV Assay with extended genotyping

Maximum throughput

Up to 210 sample results on the BD COR™ GX Instrument within one 8-hour shift
High capacity for reagents, consumables, samples and system waste
Barcode-driven chain of custody for full traceability and follow-up testing

Minimal time at the instrument

Remote system management and alert capabilities
Less than 15 minutes to fully load machine

Extended walk-away time

Approximately 6.5 hours of walk-away time at maximum throughput
Up to 180 HPV sample results with extended genotyping without user intervention
Ready-to-use barcoded reagents stored at room temperature

BD COR™ PX Instrument

High capacity

~ 480 BD SurePath™ Liquid-based Pap Test Vials
~ 2,140 BD molecular sample tubes

Automation

Sorts specimens automatically based on testing needs
Vortexes, uncaps, aliquots and recaps samples
Performs all necessary prewarming and cooling steps

Integrated

Automatically delivers samples to analytical module
Bi-directional LIS interface
Barcoding functionality supports traceability throughout sample processing and testing

Electrical requirements

Voltage	100-240 VAC
Frequency	50-60 Hz
Current	Single-phase circuit 15 A

Operating conditions

Temperature	18°C – 27°C / 64.4°F – 80.6°F
Humidity	20% to 80%
Altitude	Up to 2,000 m (6,562 ft)
Noise metrics	< 67 dB

Specimen handling*

Specimen collection type	BD SurePath™ Liquid-based Pap Test Vials BD Molecular Aliquot Tubes BD Onclarity™ HPV Liquid-based Cytology (LBC) Specimen Diluent Tubes
Reagent/consumable capacity	BD COR™ GX Instrument: 180 HPV tests; 1,056 tips (11 tip trays) BD COR™ PX Instrument: 35 racks; 192 tips (2 trays; buffer)
Waste capacity	Solid: 960 conversions (24 hours) Liquid: 2,160 tests (3 days)

*Capacity and throughput may vary based on specimen types.

Cervical Cancer Screening Portfolio

Evolving methods, one goal: the prevention of cervical cancer

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