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DiaGenic Adopts Life Tech QuantStudio Dx for Alzheimer's Test Development

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Norwegian molecular diagnostic developer DiaGenic said this week that it has adopted Life Technologies' recently launched QuantStudio Dx platform to further enable development of its pipeline of multi-biomarker blood-based molecular assays for Alzheimer's disease.

Specifically, QuantStudio Dx provides DiaGenic with a "state-of-the-art" platform that has US Food and Drug Administration approval and is ideal for performing gene expression assays from blood samples, company officials said.

Oslo-based DiaGenic will now begin the process of transitioning its molecular tests from previous Life Tech PCR systems to the QuantStudio Dx with the goal of launching the first test — an assay designed to detect Alzheimer’s disease in patients with mild cognitive impairment — in Europe this year and the US "as soon as possible," DiaGenic CMO Magnus Sjögren told PCR Insider.

"The rationale is very simple — we are a product development company and want to make sure our products are ready for the next step in development, [and] that the instruments used to evaluate gene expression in blood are state-of-the-art and FDA-approved to enable readiness of the products for market launch," Sjögren said.

DiaGenic currently has one product on the market: ADtect, a 96-gene blood-based test for the early detection of mild to moderate Alzheimer's disease. This product is currently CE marked and is sold through a "few clinical centers in Spain," Sjögren said, noting that DiaGenic's expertise is in test development, not sales and marketing.

The company also has three blood-based assays in development. The first is MCItect, designed to identify individuals with mild cognitive impairment who are at risk of progressing to Alzheimer’s disease.

The company's second pipeline product is a next-generation version of ADtect, and the third is AMYtect, a brain amyloid detection assay being developed under a collaboration agreement with GE Healthcare.

DiaGenic originally developed PCR-based blood tests for Alzheimer's disease and breast cancer using a 96-gene format run on Life Technologies' ABI qPCR microfluidic cards and 7900 HT system (PCR Insider, 6/3/2010).

But, in October 2010, amid an approximately NOK 70 million ($12.1 million at the time) financing round, the company said that it was narrowing its focus solely on the development of tests for Alzheimer's disease (PCR Insider, 10/7/2010).

And when it announced its partnership with GE last year, DiaGenic noted that it was using Life Tech's microfluidic TaqMan real-time PCR cards in conjunction with Life Tech's new ViiA 7 multiplex PCS system (PCR Insider, 3/29/2012).

"We have a long-standing and good working relationship with Life Tech," Sjögren said, adding that DiaGenic has used the company's instrumentation systems for several years. "We continuously look at … and have evaluated several different platforms. The qPCR platform from Life Tech is the one that we decided several years ago to go with, and it fits our needs."

Life Tech launched QuantStudio Dx in November (PCR Insider, 11/29/2012). The instrument is CE-IVD marked for use in Europe and received a 510(k) clearance from the FDA in March to market an assay for Clostridium difficile that it developed in collaboration with Quidel (PCR Insider, 3/18/2013).

QuantStudio Dx is an in vitro diagnostic-optimized version of Life Tech's QuantStudio 12K Flex instrument, which the company launched for research use only in October 2011. The Dx version accommodates 96- or 384-well plates, as well as qPCR microfluidic cards, which can perform 48 tests on eight samples simultaneously. The system also includes touch screen operation, reagent and sample tracking, LIMS interface, optimized sample loading, and dedicated software.

When the platform received 510(k) clearance in March for the C. diff test, company officials noted that it would pave the way for future cleared tests on the system. DiaGenic is one of the first diagnostic developers since the approval to disclose its intention to use it for future test development.

However, Sjögren declined to disclose additional details of whether or when it would move its assays to the QuantStudio.

"It depends on which product we talk about but it’s a continuing evolving process, and with inclusion of QuantStudio to our instrument park we will step-by-step … move over to using QuantStudio more and more for as many of our products as possible," he said.

DiaGenic's first priority is MCItect, which, according to Sjögren, is in "late-stage development."

"We hope to have MCItect CE marked and thereby available to the European market this year," he said. "And we also aim to start working on the validation needed for MCItect for introduction into the US market. That doesn't mean the product will be ready for the US market this year. Our ambition is to have MCITect ready for the US market as soon as possible."

Sjögren declined to disclose how many biomarkers would comprise the MCItect assay, but noted that it's built upon the same principle as the company's previous tests. "There are a number of gene probes included in this multiplexed test," he said. "I can't today disclose how many gene probes but it's similar to what we have done before."

The next-generation version of ADtect is also in the "final stage of development," Sjögren said, although he declined to provide additional timeline details. And finally, the company hopes to have a validated prototype of its AMYtect assay ready by the end of this year.

"For the development of this test we will use amyloid PET (18F-flutemetamol) as a gold standard to detect amyloid in the brain," he said. "Therefore, this blood test will detect if the patient has amyloid in their brain. It could potentially be used as a selection tool before PET in the clinic."

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