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Thermo Fisher Launching RUO Women's Health Panel as Clinical PCR Strategy Coalesces

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NEW YORK (GenomeWeb) – Thermo Fisher Scientific is in the midst of rolling out a qPCR-based research-use-only multi-target women's health panel based on its TaqMan chemistry and OpenArray architecture, company officials said recently.

The panel will feature assays for 34 total organisms along with controls, and will be primarily for use on the company's QuantStudio 12K Flex instrument. It is currently in the "soft launch" phase but will be fully commercially available by November, company officials said.

And although the panel is RUO, Thermo Fisher sees it as an important step forward in its overarching strategy to further penetrate the molecular diagnostics market with its qPCR products, which along with its capillary electrophoresis portfolio comprise the bulk of the company's genetic analysis division, itself a significant component of the company's Life Sciences Solutions segment.

Thermo Fisher's Life Sciences Solutions segment — which also includes the Ion Torrent next-generation sequencing, bioproduction, and biosciences divisions — is essentially the aggregate of multiple companies that Thermo Fisher has acquired over the last several years, and "is really anchored on the Applied Biosystems instrumentation, qPCR, CE, and NGS, and then the corresponding TaqMan assays, master mixes, [and] sample prep," Joshua Trotta, senior director of business development for clinical enablement in Thermo Fisher's Genetic Analysis division, told GenomeWeb.

The company and its predecessors have for a few years now had all the tools in place to become a major player in molecular diagnostics, but progress has come in fits and starts as Thermo Fisher worked to integrate and restructure its various acquisitions. Some of the pieces were already put in place by Life Technologies before it was acquired by Thermo Fisher in 2014 for $13.6 billion.

For instance, in 2012, the University of Florida Academic Health Center adopted Life Tech's QuantStudio 12K Flex system and OpenArray consumables to implement a new pharmacogenetic strategy to screen all incoming catheterization patients for their likelihood of responding to clopidogrel (Plavix) and other treatments. A year later, UF won a four-year, $3.7 million grant from the National Human Genome Research Institute to expand the program and implement similar initiatives at community healthcare centers across Florida.

In addition, Life Tech and clinical diagnostics firm Quidel had an agreement in place to develop and commercialize real-time PCR assays for the QuantStudio Dx, a version of the QuantStudio optimized for clinical diagnostics use. The companies also had a co-marketing agreement for Quidel's PCR-based assays on Life Tech's Applied Biosystems 7500 Fast Dx Real-Time PCR system in Europe.

In 2013, Life Tech and Quidel received 510(k) clearances from the US Food and Drug Administration to market Quidel's Molecular Direct C. difficile assay with the QuantStudio Dx and ABI 7500 Fast Dx instruments. This clearance was soon followed by the approval of two additional Quidel molecular tests for respiratory infections on the QuantStudio Dx

However, sometime after Thermo Fisher's acquisition of Life Tech the partnership with Quidel fizzled out.

A Thermo Fisher spokesperson told GenomeWeb recently that the companies "mutually decided to terminate" the commercialization and co-marketing agreements.

"However, Thermo Fisher Scientific continues to supply Quidel with reagents and other components in support of their assay development program for molecular diagnostics," the spokesperson noted. In the meantime, Quidel has developed and marketed its own molecular diagnostics instrument platforms to run its tests.

Thermo Fisher had been relatively quiet, at least publicly, on the PCR- and CE-enabled molecular diagnostics front until this year. Last month, around the time of its second quarter earnings release, the company announced a partnership with China's Health BioMed to support that company's efforts to develop molecular diagnostic kits for infectious disease and pharmacogenomics screening on the Applied Biosystems 3500Dx CE platform for the Chinese market.

Stateside, in April Siemens Healthcare Diagnostics announced that it would integrate Thermo Fisher's QuantStudio 5 platform into its Versant kPCR automated molecular diagnostics workflow in a deal that is expected to boost both companies' ability to tap into the molecular diagnostics market.

On the sidelines of the American Association for Clinical Chemistry annual meeting earlier this month in Philadelphia, Kim Kelderman, vice president and general manager of the genetic analysis division, told GenomeWeb that an important part of the Siemens deal for Thermo Fisher was gaining access to additional clinical assay development expertise that Thermo Fisher may not have had in house.

In a recent follow-up interview, Kelderman noted that Thermo Fisher has adopted this partnering strategy to help bolster its presence in the molecular diagnostics market even as it works to bring different pieces of its own business together to develop internal solutions.

"In the areas that we do not feel strong, we of course try to sell as many of our capabilities that we have in the form of [instruments], reagents, and know-how or white papers to help customers design their tests," Kelderman said. "The [Health BioMed] relationship … is a good example of us bringing the Dx box, and the partner bringing the content, which is still for us, as RUO experts, a very safe approach because both companies typically bring both of their expertise to the game. Siemens is very similar … and we've got a pipeline of partners in different content areas … to create an overarching menu that utilizes our [instruments] where customers, if they buy a Thermo Fisher Scientific box have many choices to put on there."

"So [if you] conclude that right now, at least last year, we have focused on exercising some of our muscles through partners, you'd be correct," he added. "[Whether] the mix stays the same going forward, I'd probably say it's going to shift to continuing with partnering and increasing our participation as a provider of Dx content and Dx [instruments], as well. We can see that space is growing, and we want to be a major player there, so we're doing it step by step."

Its strategy on the Dx content side so far has been to offer customers a choice of a fixed RUO qPCR panel with targets identified through literature searches and work with key opinion leaders, or a customized panel where users can add or subtract targets of interest. Following in the wake of the pharmacogenetics panel adopted at the University of Florida, examples include a recently launched cystic fibrosis carrier screening panel and the forthcoming women's health panel.

Evan Diamond, associate director of business development in the genetic analysis division, told GenomeWeb that the assays on the women's health panel "are designed to target a variety of different microbial organisms, whether they are bacteria, yeasts, or viruses … at the species level. These can also be assembled into a customized array of assays that would allow a researcher to survey broad coverage of vaginal flora, for example — these are organisms that are associated with bacterial vaginosis, other forms of vaginitis, [or] yeast infections."

In addition, Diamond noted, the company also offers assays associated with sexually transmitted infections and urinary tract infections. "These can be assembled into broad vaginitis panels, and they can also be put into smaller STI panels that would be run perhaps in a smaller format, and can be deployed across any of our instruments," he said.

Thermo Fisher's broad array of qPCR instrumentation and consumables formats lends itself well to such a strategy. While the company generally offers fixed panels on its OpenArray consumable — each OpenArray plate has more than 3,000 'through holes' and can be customized and configured with TaqMan assays for many different sample and assay formats — it can also provide customers with pared-down formats such as traditional 96- or 384-well plates.

"What we've seen is that most customers will look at content in many of these spaces … where you might have kind of a core set of markers people are generally looking at," Trotta told GenomeWeb. "But often people will say 'Well, what about this one?' Maybe it's a regionally specific application in China or Europe … and they want to modify or tweak things. I think the unique thing our platform enables, specifically within the OpenArray format, is to be able to pick and choose out of the many different assays that have been designed — the flexibility of adding just the content that the customer is most interested in viewing."

Erik Avaniss-Aghajani is co-owner and director of molecular diagnostics at Primex Clinical Laboratories, which is based in California and provides clinical diagnostic testing services to thousands of clients throughout Central and Southern California, Nevada, Guam, and Micronesian Islands. His lab has worked with Life Technologies/Applied Biosystems for many years, and adopted the pharmacogenetics panel and is an early user of the women's health panel using the TaqMan OpenArray format and QuantStudio 12K Flex instrument.

"It brings up a lot of advantages when you're using this panel as opposed to a regular vaginal culture," Avaniss-Aghajani said, mostly in terms of accuracy and turnaround time. "Compared to a vaginal culture, of course, the cost is higher, but I think the advantages really trump the cost. It depends on what the physician wants to do with it, and what targets they're looking at."

Avaniss-Aghajani also said that the lab obtained "really great data" from a trial using the PGx panel and plans to publish on this soon. "And we are now using [the QuantStudio] for some other purposes, and are looking at developing some stuff that's not on the market yet … so it's pretty open and I like what it offers."

Thermo Fisher of course can't promote the use of these RUO panels for clinical diagnostic use, but, like many other platform and reagent providers, expects that some customers will go down that route, which could eventually lead to US Food and Drug Administration-cleared products.

"If a CLIA/CAP lab is looking to deploy something like this … that's a determination they have to make, so ultimately they have to assess whether this is something they would bring in house and do both analytical and clinical validation against," Trotta said.

"But there's that natural evolution … where we do have an eye toward whether there is specific content, whether it's on our Sanger sequencing instruments or qPCR platforms, that we internally would like to … provide regulatory approved content," he added. "That's kind of a natural transition of where we're at. Do these solutions resonate with the market? And as the answer is yes, there's kind of that natural transition of looking to further build out that internally developed content."

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