This post has been updated to include comments from a Quest spokesperson.
By Kirell Lakhman
Quest has moved one step closer to reaching its goal of shifting infectious-disease testing from reference labs to hospital labs — for now at least in Europe.
European regulators have cleared a pair of new molecular assays based on its new Simplexa platform. The assays, developed by the reference lab's Focus Diagnostics business, are designed to test for Epstein-Barr and BK viruses and can be sold in 35 countries on the continent.
Simplexa tests are designed to run exclusively on 3M's novel Integrated Cycler platform, a bench-top real-time PCR machine that eliminates the need to independently extract and purify nucleic acid.
The platform debuted in 2009, and besides the EBV and BK kits Quest sells two FDA-approved kits in the US: One distinguishes 2009 H1N1 and the other tests for seasonal influenza A and B and respiratory syncytial virus. The latter is also sold in Europe.
The EBV and BK tests, which a Quest spokesperson said the company is already "promoting" in Europe, are performed on whole blood and either urine or plasma, respectively, to quantitatively detect the viruses.
Neither organism is likely to cause significant symptoms in the general population — EBV is the culprit behind mononucleosis and BK causes respiratory infections. However, they are particularly nasty in immunocompromised patients, especially those pre-infected organ-transplant recipients in whom the viruses are dormant.
In these cases the faster a lab can deliver a yes/no result the better — the Integrated Cycler can spit out an answer in less than an hour, 3M says — and that timing is a principal reason why Quest wants hospitals to install the Cyclers and buy its tests.
Moreover, the CE Mark is noteworthy from the top-line perspective because more organ transplants are performed in Europe than anywhere else in the world — nearly 32,000 last year alone — according to Quest, which cited an analysis by Global Industry Analysis.
The spokesperson would not disclose the costs of tests, but said they "are priced competitively" and "differently from country to country."
A Simplexa Strategy
Focus debuted the first FDA-cleared Simplexa test — for differentiating 2009 H1N1 virus — last spring. That December it received FDA clearance and a CE Mark to sell a test for seasonal influenza A and B and respiratory syncytial virus.
And last month, Focus and Quest began working with Scripps Translational Science to develop a CYP2C19 test for Plavix response, my colleague Ben Butkus wrote in PCR Insider.
A CE Mark for an infectious disease test of some sort was expected. According to a Quest official I spoke with at the 2009 AMP conference, Focus had “recently” placed an Integrated Cycler in an undisclosed facility in Valencia, Spain, had delivered at least one instrument to an undisclosed lab in the Czech Republic, and had been negotiating with an undisclosed facility in Grass, Austria, to install a unit.
Likewise were the indications for the new tests. 3M "fully expect[s]" to debut tests for "infectious disease with respect to hospital-acquired infections," David Whitman, senior lab manager for the company's Infection Prevention business, which developed the instrument, told me in 2009.
In fact, nosocomial infections and the need to hasten the time-to-result are key components to Quest's Simplexa strategy: The Integrated Cycler and the Simplexa kits were developed for hospital labs to buy instead of sending out samples to reference labs.
The Integrated Cycler "has a number of features that make it potentially very attractive to hospital laboratories, and we think this could dramatically increase the ability of hospitals to do high-complexity molecular testing," according to Quest medical director Jay Lieberman, my colleague Bernadette Toner wrote in GenomeWeb Daily News when 3M debuted the platform.
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