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Abbott Developing Next-Generation MDx System for 2017 Launch Outside US

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NEW YORK (GenomeWeb) – Abbott Molecular is developing a next-generation molecular diagnostics platform and menu for high-volume testing in the clinical laboratory. The firm expects to launch outside the US in the second half of 2017, and in the US in 2018.

The new system will be fully integrated, automated, and enable random-access qPCR testing, but will maintain a similar footprint to the firm's m2000 system.

"The next-generation platform is completely new," John Carrino, vice-president of research and development at Abbott Molecular, told GenomeWeb in an interview.

"A lot of time was invested upfront to understand the needs of end users ... and this system was developed from the ground up — new hardware, new software, and new disposables."

It will also exist in parallel with Abbott's m2000 MDx platform that first received US Food and Drug Administration clearance in 2010.  However, the firm anticipates that the next-generation system, which was first briefly mentioned to GenomeWeb in 2014, will ultimately replace that model.

Carrino is a recent returnee to Abbott Molecular, having helped to kick off the MDx program at Abbott early on. After ten years there he moved on to positions at Invitrogen during that firm's period of high revenue growth, followed by a stint in Becton Dickinson's point-of-care immunodiagnostics business.

Customers told Abbott they wanted to consolidate testing, Carrino said. "Most molecular testing laboratories currently have multiple platforms, and this is driven by the different kind of testing needs that they have, with some things in high-throughput, some in STAT or random-access mode testing," he said.

"One of the things that drove the design was trying to address this need for both high-throughput and random-access testing, and doing it in a minimal footprint with reduced time-to-result."

These customer needs, which Carrino said were collected over about a year, presented some challenges, particularly the pairing of high throughput with random-access.  

"Those are almost kind of conflicting requirements," he said. Higher-throughput systems are usually microtiter plate-based, while random-access testing typically requires single-test disposables. "It was a nice technical challenge, and the system design that we are developing does address both of those needs in a small footprint."

Another key piece of feedback from end users was that they shared a desire to alleviate the need for multiple platforms for different kinds of testing. So Abbott also focused on simplifying workflow and creating a system with the ability to have a "much broader menu."  

The firm had the building blocks within R&D for the project, but also brought on "significant resources in order to bring the concept to reality," Carrino said, adding people on the systems and software engineering side, but also on the assay development side.

The assays currently used on the m2000 are now being redesigned for the new platform. The initial test menu will include new versions of Abbott's hallmark m2000 quantitative assays, such as HIV, and hepatitis B and C viruses. The firm is also working on assays in the transplantation space and women's health.

"We see it being a workhorse system, where it can consolidate a lot of different kinds of testing, and this next generation is designed to have the capability of holding up to 50 different assays on board," Carrino said.

In terms of random-access, automated systems, competing technologies might include the BD Max from Becton Dickinson, or the CE-marked DxN Veris from Beckman Coulter. The latter system, which is a few years from market in the US, is high-throughput but also "load-and-go," and it can improve lab workflow and productivity according to an analysis in the UK last year.  

A prototype of the new Abbott platform was demonstrated recently for global users at an event in Vienna, Austria. The timing was motivated by the fact that the development process was far enough along to get feedback on design specifics, Carrino said. "We received tremendous feedback from people who were present at the event, in terms of capabilities and what the system is being designed to do." The prototype will now be demonstrated at a number of different upcoming conferences.  

And despite the fact that the m2000 is destined for replacement, it "has a lot of life left in it," Carrino noted.

"We're building on the high reliability and the excellent test performance we have on assays on the m2000, so we see the two co-existing for quite a while."

Abbott is also undertaking other initiatives to address customer needs, developing next-generation platforms across all of its businesses — blood screening, hematology, immunoassays, clinical chemistry, and point-of-care testing. These will also "focus on ease of use and higher throughput, while always keeping in mind footprint."