NEW YORK (GenomeWeb) — Beckman Coulter Diagnostics said this month that it has received CE marking for Veris MDx, its "sample-in, results-out" real-time PCR-based molecular diagnostics system, as well as the platform's first assay, a quantitative viral load test for human cytomegalovirus.
In addition, Beckman Coulter presented the first performance data on the platform generated by independent external collaborators from the South Bend Medical Foundation and Indiana University School of Medicine, who demonstrated that the Veris CMV assay produced comparable results to a competing test from Roche.
Taken together, the CE mark and the new data — presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona earlier this month — essentially constitute the official European launch of the platform, Richard Creager, senior vice president of molecular diagnostics and CSO of Beckman Coulter Diagnostics, told PCR Insider in an interview following the conference.
Beckman Coulter's entry into the molecular diagnostics market has been several years in the making. The company initially disclosed its plans to develop a sample-to-answer MDx system called the UniCel DxN as early as 2007, having laid the groundwork for such a system with a series of moves including its April 2005 acquisition of Agencourt Bioscience, a 2006 settlement with Applied Biosystems (now part of Thermo Fisher Scientific) over thermal cycler patents, and a licensing deal with Roche covering real-time PCR patents.
In 2008 the company inked a four-year collaborative agreement with the National University of Ireland, Galway to develop molecular diagnostic assays, and set a target of 2010 for the launch of the UniCel DxN.
That launch date, however, was pushed back several times as Beckman Coulter muddled through financial woes and layoffs, and was eventually acquired by Danaher in 2011, triggering another restructuring at the company — although it noted at the time that employees connected with the UniCel DxN development would likely be retained.
Then, at the JP Morgan Healthcare conference in January 2013, Danaher President and CEO Lawrence Culp told attendees that Beckman Coulter had begun demonstrating the platform in Europe and was about a year away from a commercial launch in the US. He also noted that development of the platform remained a major effort at the company with Danaher pumping in more than $40 million in R&D spending annually.
Last week, Creager told PCR Insider that he became involved in the project in late 2009 and, although the current Veris MDx retains the skeleton of the UniCel DxN, the platform's original design was scrapped and restarted in 2010.
"We've spent a lot of time … listen[ing] to customers, mak[ing] sure we really felt the pain points our customers were feeling, and we took our time to make sure we were really addressing those … [and] the difficulties they have today with … current systems on the market," Creager said. "We wanted to make sure we had the right product that would truly help resolve those pain points and clearly differentiate our product from everyone else's on the market."
Veris MDx enters a highly competitive market populated with fully integrated molecular diagnostic systems from companies such as Roche, Qiagen, Hologic, Cepheid, Becton Dickinson, and Abbott, to name just a few. The company believes Veris MDx is different from those companies' platforms primarily in the areas of ease of use and the ability to conduct random-access testing, Creager said.
"From our point of view this is clearly one of the first truly random access systems coming on the market," he said. "We only have five touch points for a user to actually start the system: load the samples, load the extraction cartridge, load the assay-specific reagents, close the door, [and] hit the start button." If a user wants to run a single assay that is different from those currently being run on the system, "they can open the loading door and slide that sample right in, and within two and a half minutes the instrument is going to pick it up and off it goes," Creager added.
The instrument fully automates nucleic acid extraction, quantitative or qualitative real-time PCR, and test reporting. Five different detection channels enable multiplexed assays, and turnaround time is just over an hour for a DNA test and just over 1.5 hours for an RNA test.
As such, the platform can perform approximately 150 DNA target assays or 100 RNA target assays in an eight-hour shift. "Our research would indicate that is anywhere from a mid[-sized] to large hospital laboratory, and that's really the target market," Creager said, adding that the company would aim for a moderate complexity CLIA rating in the US.
For sample prep, Beckman Coulter has previously noted that the platform would make use of a proprietary nucleic acid isolation chemistry developed at the company called SNAP. Creager confirmed that this technology is still being used, but declined to provide details on it, citing its proprietary nature. "All I can say is that we don't use any organics," Creager said. "It's an aqueous based … chemistry [that] really simplifies the extraction process."
One major issue that crops up in molecular diagnostics and that Beckman Coulter said it is addressing with Veris MDx is cross-contamination due to running different assays on the same system.
"When we were talking to customers … about putting together a sample-in, result-out system … they expressed the concern about the possibility of amplicon contamination," Creager said.
"We put a number of processes in place to minimize that," he added. "One is the physical layout of the instrument. Secondly, we have a PCR vessel which, once the extracted nucleic acid is eluted from the particles, it's put into this vessel and the master mix is added, and … the instrument places [a cap] onto the vessel irreversibly."
Those capped vessels are then moved to the instrument's parallel thermal cycler components, and "even in the way the pipettor moves, we've tried to minimize at all steps any possibility of even a drip contaminating one sample to the next," Creager said. Finally, the assay master mix contains uracil DNA glycosylase, better known as UDG, which has been shown to prevent carryover of DNA in PCR reactions.
In a poster at the ECCMID conference earlier this month, Beckman Coulter scientists described the system's various safeguards for preventing carryover contamination and evaluated 27 high-risk areas on the platform for contamination problems using spiked-in cytomegalovirus samples. In this exercise, the researchers were not only able to identify and address potential trouble spots, but Veris MDx was able to "provide accurate results for true negative samples and did not exhibit detectable carryover from high positive samples to negative samples," the researchers wrote.
At ECCMID, scientists from Beckman Coulter, South Bend Medical Foundation, and Indiana University School of Medicine also presented a poster describing the performance of the Veris CMV assay, which Beckman Coulter said is designed to quantitatively assess CMV DNA from human plasma and, when used in conjunction with clinical presentation and other laboratory findings, aid physicians in monitoring CMV viral load.
Specifically, the researchers compared Veris CMV to Roche's CE marked Cobas AmpliPrep/Cobas TaqMan CMV assay by testing 160 paired plasma samples using two Veris instruments and two Roche instruments each at different sites. The total imprecision of the Veris CMV assay was less than or equal to 4.6 percent coefficient of variation across the measuring range of the assay in log international units/mL — essentially comparable to the Roche assay across the assay measuring range. They also determined that the system had a clinical specificity of 100 percent by testing 287 CMV-negative plasma samples using two Veris MDx systems.
At the conference, Beckman Coulter scientists also presented posters detailing equivalent performance of separate Veris MDx tests for the quantitative detection of hepatitis B and C viruses compared to similar Roche assays.
Beckman Coulter said in a statement last week that it plans to expand the Veris infectious disease test menu this year by submitting for CE marking assays for HBV and HCV, as well as HIV. Creager declined to provide a specific list of other targets being pursued by the company, adding only that it was developing tests in the areas of sexually transmitted diseases and hospital-acquired infections.
In February last year PCR Insider reported that NUI-Galway, partners with Beckman Coulter under the aforementioned molecular diagnostics development agreement, had finished transferring some 30 single-plex and seven multiplex molecular assays for various bacterial, fungal, and parasite targets to Beckman Coulter, even as it ramped up its own MDx commercialization efforts through a spinout company.
It is unclear whether Beckman Coulter is moving forward with any of those assays for the Veris MDx system. Creager told PCR Insider that all of the product-development activities for the platform are now internal. Terry Smith, head of the NUI-Galway lab that partnered with Beckman Coulter, did not return an email prior to publication of this article.
Creager said that clinical studies for Veris MDx are ongoing in the US and Europe, with all beta testing currently being done in Europe.
In terms of US commercialization, the company is now aiming to submit the system for US Food and Drug Administration clearance in 2015, Creager noted.