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Roche Unveils Higher-Throughput Cobas Systems as it Maps out MDx Strategy

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Roche Molecular Systems this week unveiled the blueprint for its future molecular diagnostics strategy, providing attendees of the EuroMedLab conference in Milan, Italy, with a preview of its next two large-scale MDx systems.

Specifically, Roche introduced the Cobas 6800 and Cobas 8800 — essentially high- and very-high-throughput versions of the company's Cobas 4800 platform, which is already commercially available along with several US Food and Drug Administration-approved molecular assays.

Roche has already conducted extensive beta testing of the new platforms and plans to launch them with CE marking in the second half of 2014, primarily focusing on the virology testing market, Neil Gunn, head of global business at RMS, told PCR Insider this week.

By that time, the company also will have expanded the test menu for the Cobas 4800, and the three Cobas platforms together will become RMS's primary molecular diagnostics system products.

"We've already got the [Cobas] 4800, and we're moving now to expand into the larger testing segment, and that's where the 6800 and 8800 come into play," Gunn said. "That's what we've unveiled at EuroMedLab this week — the first public showing of the instruments. And that's what we'll be consolidating our menu on going forward — [going] from a mixed set of instruments ranging from LightCycler, Cobas, [and] Cobas AmpliCor — obviously looking to retire those and consolidate onto an instrument platform family of the Cobas 4800, 6800, and 8800."

RMS's Cobas 4800 platform combines the Cobas X 480 sample prep module and Cobas Z 480 real-time PCR analyzer. The 4800 is fully automated, requires less than 20 minutes of setup for a full run of 94 samples, features bi-directional connectivity with LIMS, and can process up to 384 samples per day, making it "efficient for labs with lower throughput requirements," according to the company's website.

Meantime, the new higher throughput Cobas 6800 will be able to process up to 300 molecular diagnostic tests in an eight-hour shift, while the very-high-throughput Cobas 8800 will be able to process up to 1,000 tests in an eight-hour shift.

Both systems, the company said, are as simple to use as their 4800 predecessor, provide results in approximately three hours, and provide uni- and bi-directional interfacing with LIMS. In addition, the systems feature anti-contamination measures, RFID tracking capability, and are designed to accommodate continuous sample loading regardless of test type, meaning that no test batching is required. Further, both instruments can run as many as three different assays from one sample.

Gunn said that the main difference between the new systems and the 4800 is the throughput.

"Over the last 15 or 20 years we've seen an evolution … where we're now seeing that the … marketplace is consolidating and moving, and in fact following somewhat of the centralized testing model that we saw with serology and immunology some time ago," Gunn said.

"Because [the 4800] is modular, [we] target that at some of the smaller labs," Gunn said. "We're looking toward the 6800 and 8800 to provide that extra capacity to the labs, so they can expand, consolidate their testing, bring more testing in, and ultimately [have] that higher capacity to continue to move forward."

The ability to mix test batches on the 6800 and 8800 is also a feature that the company incorporated based on customer feedback. This feature is currently not available on the 4800, but will be, Gunn said.

In addition to the 4800, RMS currently offers a slew of molecular testing systems, some of which have been around for the better part of a decade. These instruments include the Cobas p 630 pre-analytical tube handling instrument; Cobas s 201 nucleic acid testing system for blood screening; Amplicor analyzer automated PCR system; AmpliPrep sample prep module; AmpliPrep/Cobas TaqMan system; and Cobas TaqMan 48 analyzer.

It is unclear how many of these platforms the company plans to discontinue and replace with the 4800, 6800, and 8800, but the company expects that, for the most part, existing customers of the older systems will want to upgrade to the new systems as they continue to increase their throughput — although there will be an opportunity for completely new customers as MDx testing consolidates in certain markets.

"I think we've got some very clear market segments," Gunn said. "If you look outside the US, like Japan, there are some very large centralized testing models. In the US obviously we've got Quest and LabCorp, where our virology menu is on our slightly older platform, the [Cobas AmpliPrep/Cobas TaqMan]. However, we're looking more at retiring that instrument and consolidating onto a single 6800 or 8800, as opposed to potentially four or five CAP/CTMs to do the same amount of testing."

The CAP/CTM and Cobas 4800 platforms compete primarily with similar automated molecular testing systems from the likes of Abbott, Becton Dickinson, Hologic's Gen-Probe, and Qiagen. But Gunn said that RMS believes its new systems will "provide a level of automation that's been unprecedented in the molecular space. We believe we're very well-positioned for the future with the 4800 as being the product that truly can compete against those others; and the 6800 and 8800 will take it to the next level."

The 4800 currently features FDA-approved assays for human papillomavirus, chlamydia and gonorrhea (CT/NG), and EGFR mutation detection to guide treatment of non-small cell lung cancer patients with Tarceva (erlotinib) — a test that just received clearance earlier this month.

Gunn said that RMS plans to expand the menu on the 4800 this year in Europe with additional microbiology tests — methicillin-resistant and –sensitive Staphylococcus aureus, herpes simplex virus, and Clostridium difficile.

And next year, during the first six months of the Cobas 6800 and 8800 system launches, RMS will make several assays available in countries recognizing the CE mark. These assays will include HIV, hepatitis C, hepatitis B, and cytomegalovirus for virology labs; and combined assays for HIV/HCV/HBV and parvovirus B19V and hepatitis A, as well as individual assays for West Nile virus and hepatitis E for blood screening labs.

Following full commercial launch, the systems will support additional assays including human papillomavirus and CT/NG, and will feature "a utility channel for user-defined apps," the company said.

RMS will likely offer future oncology assays and companion diagnostics on the Cobas 4800 only, primarily because those types of assays do not require the level of throughput offered by the 6800 and 8800 systems, and are typically performed in more specialized testing laboratories where a 4800 would make more sense. "There is no technical reason — it's purely from a volume and throughout perspective," Gunn said.

Regarding potential FDA approval for the 6800, 8800, or associated tests, Gunn noted that it was still too early to provide a definitive timeline.

"So much in the US is dictated by the clinical trials, the FDA pathway," he said. "We're getting good traction and have very good collaboration with the FDA. So the clinical trial pathway has been very well established, and clearly it will come after the European launch … but is really based on the clinical trials and FDA timeline."

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