BD Diagnostics this week announced the European launch of its BD Max Open System — a six-color version of its legacy BD Max system that will allow labs to perform both IVD/CE and laboratory-developed tests on the same automated platform.
A US launch of the system is scheduled for later this year.
Concurrent with the European launch, the company said that it has partnered with Belgium's Diagenode to develop seven CE-Marked molecular diagnostic assays for the system focused on pathogens associated with respiratory, enteric, and central nervous system diseases.
The Diagenode agreement is the first in what the company expects to be a string of similar deals with molecular diagnostics developers in order to expand the number of tests that can run on the system. Under the agreement, the partners will develop a panel for diagnosing respiratory infections, two panels for diagnosing virus- and parasite-based gastrointestinal infections, and a panel for differentially diagnosing meningitis.
BD plans to integrate these assays onto the BD Max platform and will be responsible for manufacturing and commercializing the tests globally.
"Diagenode is hopefully the first of many" such agreements, Gregory Meehan, vice president of molecular diagnostics and project lead for the BD Max, told PCR Insider.
Meehan likened the company's strategy to Apple's App Store, which encourages third-party development of applications of interest to iPhone and iPad users. BD will develop its own assays for the system, particularly in the areas of hospital-acquired infection and sexually transmitted diseases, "but when you look at molecular [diagnostics], that puts us in a very narrow band. Frankly, there are many other applications … where it's not appropriate to keep it within our muscle mass," he said.
The model that BD is pursuing with Diagenode and other partners "is a great vehicle for companies that have a mission statement to develop molecular assays but don't have the wherewithal to develop the platform," he said. "With our open architecture we think it's very easy — we ship Max instruments to these partners, they take their assays and port them over, get them to operate like their predicate assay does in the marketplace, and then BD will take it through the [US Food and Drug Administration]."
BD is eyeing a range of possibilities for future third-party assays, but Meehan said the company is particularly interested in transplant testing, oncology, and pharmacogenetics. "We don't see BD developing these assays," he said. "We believe there's ample content and expertise out there and we're going to shop for the best and form these partnerships à la the Diagenode partnership."
Meehan said the company expects to eventually have between five and 10 partners who will contribute content to the system, "and allow BD Max to have the broadest range of solutions [that] can all cohabitate on the same platform very easily and flexibly."
Open Minded
The six-color BD Max Open System is a next-generation version of a platform that began as HandyLab's Jaguar system, which BD acquired in 2009. BD claims that the new system is the first fully automated bench-top molecular testing workstation that is able to perform both IVD/CE and laboratory-developed tests, also called user-defined protocols. The system performs sample preparation, DNA and RNA extraction, real-time PCR, detection, and result reporting in a single device.
Meehan noted that most automated testing platforms that run IVDs are "closed systems" that can run only assays developed by the instrument's manufacturer. Systems such as Cepheid's GeneXpert, for example, require customers to use special assay cartridges, making home-brew test development impossible.
BD Max allows labs to buy a single instrument to run user-defined protocols, as well as IVDs from BD and third-party providers. Meehan noted that the company believes that molecular diagnostics should be cleared as IVDs whenever possible, but noted that "the LDT market that we want to serve is important and is indispensible to healthcare," making it an important capability for the platform.
"If [a test is] a relevant, standard-of-care product then we will certainly seek to get it FDA-cleared," he said.
The BD Max system is expected to appeal to hospital labs that currently have to send out many specialized molecular tests.
"Our vision with BD Max is to drive a flexible, easy-to-use platform as close as possible to acute care patients in diagnostics [and] support direct therapy decisions," Meehan said.
BD is planning a late-2011 European launch for several CE-IVD-cleared assays it has developed internally — for methicillin-resistant Staphylococcus aureus, Clostridium difficile, and Group B Streptococcus.
"Then in 2012 you'll start to see CE-marked Diagenode assays available in the European market, and then that will be followed in the US," Meehan said.
Last year the company received 510(k) clearance to market its Group B Streptococcus assay for the current version of the BD Max, and Meehan said the company will seek FDA clearance for a new assay for the 6-color version of the BD Max platform once that is launched in the US later this year.
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