This story has been updated from a previous version to include additional information about the QuantStudio Dx platform.
Life Technologies is readying for market a molecular diagnostic version of its QuantStudio 12K Flex Real-Time PCR system, the company confirmed this week, further accelerating its recent push into the molecular diagnostics space.
In addition, Life Tech and clinical diagnostics developer Quidel have inked an agreement to develop and commercialize real-time PCR-based assays on the platform, officials from both companies said.
The new platform, to be called QuantStudio Dx, "will have features and benefits different from existing" QuantStudio 12K Flex systems, a Life Tech spokesperson said in an e-mail to PCR Insider, declining to provide additional details because the system is not yet commercially available.
The spokesperson added that the system "will be available in Europe late this year and in the US in early 2013."
Life Tech launched the QuantStudio 12K Flex in October for research use only (PCR Insider, 10/13/2011). The platform enables users to perform both low-throughput and high-throughput quantitative and digital PCR on the same sample using the same software interface with a variety of the company's formatted assay cards — for example, 96- and 384-well TaqMan assays, 384-well TaqMan array cards, and OpenArray digital PCR cards — using interchangeable blocks.
Life Tech had not previously hinted at the molecular diagnostic potential of the platform. However, in recent weeks, the company has made a number of acquisitions and signed several agreements designed to quickly build its molecular diagnostics business, and it became clear that the QuantStudio, or some iteration thereof, would be part of those plans.
For instance, late last month the company disclosed that the University of Florida Academic Health Center had adopted the QuantStudio 12K Flex running OpenArray digital PCR consumables to implement a new personalized medicine strategy to screen all incoming catheterization patients for their likelihood of responding to the anti-platelet drug clopidogrel (Plavix) and other treatments (PCR Insider, 6/28/2012).
Despite the clinical slant to this partnership, company officials said at the time that Life Tech had no immediate plans to pursue US regulatory clearance to market the QuantStudio as an in vitro diagnostic platform.
Then, last week Life Tech said that it was acquiring consumer genetic testing firm Navigenics primarily for that company's CLIA-certified laboratory and physician's network, thus enabling it to more quickly move into the personalized medicine space.
Following news of that acquisition, at the American Association of Clinical Chemistry meeting in Los Angeles, Ronnie Andrews, Life Tech's president of medical sciences, said that the company was planning additional acquisitions in the coming months. Further, Andrews noted that in the near term the company's laboratory-developed tests for cancer and other therapeutic areas would likely be based on qPCR — as opposed to next-generation sequencing — especially considering the fact that Life Tech already has a US Food and Drug Administration-approved qPCR platform: the 7500 Fast Dx system.
And earlier this week, Life Tech acquired Pinpoint Genomics and its early-stage non-small cell lung cancer test designed to help doctors identify early-stage patients at high risk for progression to late-stage disease — a test that was developed on the 7500 Fast Dx and will continue to be offered in the US on that platform. Life Tech also said that it planned to pursue in vitro diagnostic certification outside the US in order to eventually leverage its global installed base of the 7500 Fast Dx.
In the meantime, Life Tech advertised through social media networks that it was providing visitors to its AACC exhibit booth a preview of the QuantStudio Dx system "currently in development for investigational use."
Finally, yesterday, officials from Quidel — which already had a partnership in place with Life Tech to market Quidel's PCR-based molecular diagnostic assays for use on 7500 systems in Europe (PCR Insider, 9/22/2011) — disclosed during a conference call discussing the company's second-quarter earnings that it had entered into a new partnership with Life Tech for molecular diagnostic development.
"We recently entered into a partnership with Life Technologies for the development and commercialization of real-time PCR assays on their new instrument system," Quidel CEO Douglas Bryant said during the call.
Under the arrangement, Quidel will receive certain payments from Life Technologies in connection with development activities that will be reflected as part of contract revenues as early as the third quarter of this year, Quidel CFO Randy Steward said during the call, further noting that the agreement centered on "a brand new instrument platform, not yet launched" by Life Tech.
In addition, Tammi Ranalli, senior director of the molecular diagnostics business unit at Quidel, is slated to give a presentation at the European Society for Clinical Virology annual meeting in Madrid, Spain, in September, entitled "Quidel Molecular Viral Assays and the QuantStudio Dx CE-IVD qPCR Platform."
This week, neither Quidel nor Life Tech officials could confirm whether the QuantStudio Dx had received the CE IVD mark or a timeline for such registration; however, Life Tech's spokesperson confirmed that Quidel's Bryant and Steward were in fact referring to the QuantStudio Dx during the Quidel conference call.
It is unclear how exactly the QuantStudio Dx might differ from the current RUO platform. However, a spokesperson for Life Tech confirmed that the platform will not be enabled to run digital PCR assays.