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Becton Dickinson Expanding High-Throughput BD Cor Menu After US Launch


NEW YORK – After a two-year introductory period in Europe, Becton Dickinson recently launched its high-throughput, automated molecular diagnostics system in the US. The firm plans to entice customers with its Onclarity human papillomavirus test on the Cor system while also unveiling this week additions to its infectious disease test menu.

Specifically, BD has entered into a public-private partnership with the US Health and Human Services' Office of the Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority, or BARDA, which will afford the firm up to $40.3 million to develop five assays, including two on the BD Cor.

One of the assays for the BD Cor system is being developed to detect and distinguish SARS-CoV-2 from influenza A, influenza B, and respiratory syncytial virus. The other will be a novel pan-coronavirus test to detect and distinguish SARS-CoV-2, Middle Eastern Respiratory Syndrome, and seasonal coronaviruses, as well as novel or emerging coronaviruses.

This new infectious disease menu is part of an overall strategy to position the BD Cor for use in high-throughput and reference laboratories that have begun consolidating their molecular testing.

The Cor was initially described in 2018, launched with a CE mark in Europe the following year, and obtained US regulatory approval in August in the form of a premarket approval supplement for the firm's already-cleared HPV Onclarity assay.

The system sports a phalanx of robotics to automate the molecular diagnostics workflow as well as a hotel for samples that provides on-system storage. "The goal of the BD Cor system is to really reduce touch points," said Chris Beddard, business line leader of core MDx and women's health and cancer at BD Integrated Diagnostic Solutions, in a recent interview.

The BD Onclarity assay on the BD Cor in particular can manage 128 sample results every eight hours. "But, based on the limited touch points, we actually extend that to 330 with eight hours of labor [because] we replenish consumables towards the end of a shift and continue testing into a second shift," Beddard explained.

For the technologists — who are in short supply and possibly burnt out by the pandemic — the whole workflow of molecular testing is thus reduced to loading and unloading samples, Beddard said. This eliminates steps like vortexing, aspirating, heating, pipetting, and aliquoting samples, allowing robotics to take care of the tedium so that highly skilled humans can move on to other tasks.

"We like to call it 'integrated automation,' so within the system there is not additional manipulation of the sample, even just transferring it from one instrument to another," Beddard said.

On a granular level, and as previously reported, the system consists of a pre-analytical module called the PX and a testing module called the GX. The firm also has a configuration called the dual GX which increases capacity and throughput, and it has a third module in development, Beddard said.

The PX module manages the loading and unloading of various sample types from the sample collection vials and performs pre-analytical preparation. It also uses inexpensive racks and has a robotic arm that can uncap and recap the sample vials.

The PX then sends prepared samples to the GX module without a need for any manual steps.

These modules are designed to be accessed from the front for easier servicing and a smaller footprint, and the on-board hotel system can store up to 480 SurePath liquid-based cytology vials.

HPV Onclarity on BD Cor

HPV is the primary cause of cervical cancer, with certain strains of the sexually transmitted infection more likely to lead to cancer if they are not detected early.

BD's HPV Onclarity test has been available in Europe since 2014. It was cleared in the US in 2018. It was the first assay to be adapted to the Cor, and the overall system has seen uptake in Europe since launching, Beddard said.

The BD Onclarity extended genotyping assay detects 14 high-risk strains of HPV and individually reports out six, Beddard said. Specifically, it calls out HPV genotypes 16, 18 and 45, as well as 31, 51, and 52.

The clinical utility of reporting strains beyond the well-established 16/18 and 45 is still being established, but evidence is accumulating that local and regional variability can be significant. The clinical significance of different strains may also be evolving as more people get the HPV vaccine.

"Based on regional needs, we are able to provide the right information to clinicians," Beddard said, adding that same-genotype HPV persistence is also a key to identifying higher-risk cases.

With its high throughput, the Cor system is likely to be most useful in labs that have high testing volumes.

And, as countries have changed their cervical cancer paradigms in Europe to include genotyping or sought alternative partners for screening, BD has picked up business for the Cor, Beddard said.

In addition to Europe and the US, the firm is also looking at opportunities in Australia and other countries as well, she added.

A team of international labs recently validated the Cor system and HPV assay, as reported in the American Journal of Clinical Pathology last month.

Jesper Bonde, the manager of the molecular pathology lab at Hvidovre Hospital in Denmark and corresponding author on the study, said his team has been using the BD Cor system since last year.

In AJCP, the researchers — who represented labs in Norway and Belgium as well — reported high inter-laboratory reproducibility and agreement for the Onclarity HPV on the BD Cor, with an average daily hands-on time of 58 minutes and a walkaway time of 7 hours and 2 minutes per eight-hour day shift.

"The BD Cor instrumentation and the BD Onclarity HPV assay are [now] mainstays for the cervical screening program in the capital region of Denmark," Bonde said in an email.

Previously, Bonde and his colleagues had run HVP testing on the BD Viper LT system, but they now use the Viper for patient self-collected vaginal samples and the Cor for cervical samples.

"This combination allows us to continue using our Viper LT as well as provides us with additional capacity whenever needed," he said.

For Bonde, the decision to use the Cor for cervical cancer screening was based more on the added value of the Onclarity extended genotyping test rather than specs of the Cor instrument. The team appreciated that the test is among the most substantially validated commercial assays and that it performs well, he said. The team is using the extended genotyping feature in its screening program "to allow the optimal balance between clinical sensitivity and specificity," he said.

Other options in the high-throughput, fully automated MDx space for HPV assays could include systems like the Abbott Alinity m, Roche 6800/8800 with a 312 pre-analytical unit, configurations of the Panther systems from Hologic, or even the Qiagen NeuMoDx 288 system.

Prior to using BD systems, Bonde and his team had relied on the Roche Cobas HPV test, he said, noting the Cobas assay reports 12 genotypes. The Abbott Alinity m was not fully validated when the lab was making its choice for a new system, and there were not yet published studies on its use, he noted.

The extended genotyping component of the BD Onclarity HPV assay has proven "very useful indeed," Bonde said. "By utilizing the knowledge of genotyping, our screening program benefits from an unprecedented ability to distinguish between women who need immediate follow-up or who can be referred for later retesting," he said. This benefits the patients, the public health system, and society overall, he added.

In terms of additional menu, Bonde said his team specializes in HPV and oncology, so as such could have use for things like biomarker-based risk stratification assays on the BD Cor, should such a test ever be developed.

Overall, the need for HPV screening has been emphasized by the World Health Organization as part of a drive to eliminate cervical cancer globally, Bonde said. High-performing instruments and assays can make state-of-the-art technology available globally, he said, adding, "Elimination of a cancer is a worthy target for our joint efforts."

Going forward, BD believes that the Cor and Onclarity will be "price competitive" in the US, Beddard said, noting that the Cor can be placed through capital sales, reagent rental, or lease arrangements.

"We believe we have opportunities, given the assay design and also the unique automation that BD Cor provides," she said.