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BD Provides Roadmap for MDx, Microbiology Lab Offerings at ECCMID

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MADRID (360Dx) – Becton Dickinson over the weekend provided a roadmap for its molecular diagnostics and microbiology laboratory businesses with the unveiling of several soon-to-be launched products.

At the European Congress of Clinical Microbiology and Infectious Diseases held here, BD introduced its first new molecular testing platform in several years, the BD Cor, a fully automated high-throughput, real-time PCR testing system expected to launch next year in Europe and compete with the likes of similar platforms offered by Roche, Abbott, and Hologic.

In addition, the company showed off its soon-to-be launched BD Synapsys microbiology informatics software to help laboratories manage testing and receive assay results and other data in real time from the company's automated blood culturing, specimen processing, and point-of-care immunoassay systems. Longer term, this product will also support BD's molecular testing systems.

Finally, BD discussed the pending commercial availability of new modules to enhance automation for its BD Kiestra clinical microbiology processing platform, which prepares samples for analysis with the company's MALDI microbial ID and Phoenix antibiotic susceptibility testing platforms.

With the forthcoming products, BD seems to be making a conscious effort to provide clinical laboratory and microbiology customers with a more integrated suite of products, and to seize on the industry trend to integrate traditional IVDs and molecular diagnostic testing.

BD's new molecular testing platform will build on the well-established BD Max platform, which has been on the market for several years and has built up a comprehensive assay menu during that time with a mixed model of in-house and partnered test development.

BD Cor will launch in Western Europe beginning in mid-2019 following required regulatory authorization and in the US after that (with no specific timeline as of yet). It is "not a replacement for the BD Max," but instead is complementary, Nikos Pavlidis, VP of molecular diagnostics and women's health and cancer for BD Life Sciences, said in an interview.

Instead, BD Cor is a "higher volume system to address specific testing needs." The BD Cor system will run 96-well plates (the BD Max runs one to 24 tube-based assays at a time), and samples can be completely randomized. The system's cabinet doors contain full robotics for automation and integration of all pre-analytical and analytical steps in a molecular assay, which is intended to greatly reduce the workload of laboratory staff and reduce the potential for manual errors.

In a nutshell, the platform will be targeted toward more centralized testing laboratories, while the BD Max is intended to be more of a decentralized platform for smaller labs. This much is obvious from the size of the instrument, which would easily fill up most of a wall of a typical laboratory, putting it in the same category as high-throughput platforms such as Roche's Cobas systems, the Hologic Panther, and the Abbott m2000.

(Abbott, which currently sells the m2000 for high-throughput molecular testing, has been developing a new high-volume molecular testing system called the Alinity m, but declined to discuss the platform with 360Dx at ECCMID).

One of the main things that will set BD Cor apart from competing platforms, Pavlidis said, is that it will hit the market with a relatively full menu of real-time PCR assays that are already commercialized and well-validated.

These include a number of CE marked and US Food and Drug Administration-approved women's health and sexually transmitted disease assays; a CE-marked and FDA-cleared enteric bacterial panel; a CE-marked assay to screen for antibiotic-resistant carbapenemase-producing organisms; and a recently FDA-approved test to detect 14 high-risk human papillomavirus types.

Some of these tests are designed to be run on the BD Max, while the HPV assay, along with the company's triplex test for chlamydia, gonorrhea, and trichomonas, currently run on the company's higher-throughput BD Viper LT system. Pavlidis noted that the Viper LT system will continue to support theses tests for the company's low- to mid-volume testing customers.

The HPV genotyping test will be the first and arguably most important in the planned BD Cor menu as the lab industry begins moving toward HPV testing as a primary screen for cervical cancer, which would surely grow the market for high-throughput molecular HPV typing assays.

The BD Cor will have a dedicated HPV module at launch that will eventually be followed by modules for STDs and enteric diseases, and all of the tests will eventually be able to be mixed and matched on the same system.

Connectivity

The new molecular testing piece at BD will also dovetail with another new diagnostic lab product — the Synapsys microbiology informatics software — though not in the near-term.

Instead, Synapsys, which will launch "very soon," according to Steve Conly, vice president and general manager for microbiology diagnostic systems at BD LIfe Sciences, will initially support BD's portfolio of non-molecular microbiology systems. It is, however, "in the roadmap" to eventually use this laboratory informatics system to connect the BD Max and BD Cor with each other and with other non-molecular systems.

Specifically, Synapsys initially will connect the BD Bactec FX, BD Kiestra, and in the US only the BD Veritor Plus systems. The BD Bactec Fx is a blood culturing platform built around fluorescence detection technology, while Kiestra is a laboratory automation system that processes samples for downstream bacterial identification and antibiotic susceptibility testing using the BD Bruker MALDI and BD Phoenix systems, respectively.

BD saw a need to connect these systems and eventually its molecular systems via a single laboratory informatics package because labs have traditionally struggled with IT, the ability to connect various testing modules to laboratory information management systems, and the ability to gain insights in real time, Conly said.

This new platform is intended to enable all of this and is scalable in that it will be able to connect multiple platforms in a single lab or even multiple labs via cloud infrastructure, with a heavy focus on cybersecurity.

Conly noted that external solutions (even an existing BD product, the Epicenter Microbiology Data Management System) purport to do some of this, but there was a need for an updated platform to tie everything together and, importantly, provide and integrate real-time actionable results for physicians.

In a statement provided by BD, Alanna Emrick, a microbiology manager at University Medical Center Health System in Lubbock, Texas and a collaborator with BD on the development of Synapsys, noted that "BD understands our lab needs an advanced informatics solution that supports integrated workflow across lab instruments, with access to data across all systems to better utilize our resources, reduce turnaround times and error rates, and show efficiency data in order to maximize the usage of our instrumentation to ultimately allow us to better serve our physicians and patients."

Automating microbiology

Finally, BD will launch new ID/AST modules for its Kiestra microbiology laboratory system, with the BD Kiestra ID module offered in early 2019 and the ID/AST module available in mid-2019, initially in Europe and Canada. Availability in the US and other regions will follow after regulatory authorizations are secured, BD noted.

Conly explained that the BD Kiestra platform currently automates a number of crucial microbiology laboratory tasks such as plate handling, bacterial streaking, culture, and imaging. The new modules will automate some areas where there have been gaps, for instance, picking colonies, MALDI plate prep, and antibiotic susceptibility testing.

The goal is to automate all the processing steps prior to bacterial identification on the BD Bruker MALDI system and antibiotic susceptibility testing on the BD Phoenix system. The new lab automation modules will use a single organism to ensure that the same bacteria is used in both the ID and AST tests, BD said.

In addition, the modules will "drive efficiency in the lab, reduce hands-on time, eliminate errors, and ultimately help clinicians make timely patient management decisions," the company said in a statement.

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