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Thermo Fisher Putting Pieces in Place to Tackle PCR-Based Testing Markets

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By Ben Butkus

Thermo Fisher's $260 million planned acquisition of molecular biology research tool shop Fermentas, announced last week, will undoubtedly strengthen Thermo Fisher's rapidly expanding portfolio of PCR research products as it looks to compete on that front with rivals such as Life Technologies, Qiagen, and Sigma-Aldrich.

However, when considering the breadth of Fermentas' molecular biology portfolio, which includes several unique polymerases and probes, restriction enzymes, and sample prep products; as well as Thermo's acquisition earlier this year of Finnish PCR firm Finnzymes and its proprietary polymerases and miniature thermal cycler, it appears as if Thermo is putting together the pieces to make a run at disease diagnostics, food testing, and other PCR-based testing markets.

"Without question, our strategy is to build a portfolio of products and tools … that enable us to make those products and tests available to customers in the future," Mitch Kennedy, vice president and general manager of biosciences at Thermo Fisher, told PCR Insider in an interview following the announcement of the Fermentas acquisition.

"We're certainly interested in PCR-based testing and the markets that those tests can serve," he added.

Fermentas, with headquarters in Burlington, Ontario, and principal operations in Vilnius, Lithuania, provides a broad range of molecular and cellular biology research tools. And, despite what Kennedy called "moderate overlap" between Fermentas' and Thermo's overall product portfolios, Fermentas was a particularly attractive acquisition target because of its PCR, RT-PCR, and qRT-PCR products; as well as its enzymology expertise.

"What attracted us to Fermentas was that they have an extensive range of restriction enzymes, but they also have a very comprehensive range of molecular weight markers, which are very commonly run on gels with PCR products," Kennedy said.

"They have a comprehensive portfolio of molecular and cellular biology research tools, but within that portfolio they have specific developments in reverse transcription … master mixes, and enzymes that very much complemented what we already had with our Solaris product launched in late 2009 and with the enzyme capabilities that we acquired from Finnzymes," Kennedy added.

Launched in October, Thermo's Solaris qPCR gene expression assays use minor groove binder and "superbase" technologies for repeatable, sensitive, and gene-specific quantification. Meantime, Thermo has said that Finnzymes' Phusion and Phire DNA polymerases outperform Taq-based polymerases in terms of speed and fidelity and are ideal for both routine and high-throughput PCR applications, and are thus complementary to the Solaris kits.

In picking up Fermentas, Thermo will also acquire a portfolio of reverse transcriptases that Kennedy said would be used to improve Thermo's existing RT-PCR assays. These reverse transcriptases include Moloney murine leukemia virus, and RNA- and DNA-dependent DNA polymerase; as well as next-generation versions of the M-MuLV RT, such as RevertAid RT, which has an increased cDNA synthesis rate compared to its predecessor; and Maxima RT, which features RNase H activity and improved thermostability, robustness, and increased synthesis rate.

Another particularly attractive product to Thermo was Fermentas' "fast-digest" restriction enzyme that allows scientists to perform a restriction digest in five minutes.

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"PCR is such a laboratory workhorse," Kennedy said. "The fast digest enzymes enable scientists to get their work done more quickly and efficiently. PCR is getting faster, and they’ve come up with some very clever ways of enabling the restriction digest portion of recombinant DNA technique to be performed in a much faster way."

In general, Kennedy cited Fermentas' "deep and talented R&D staff" in the areas of enzymology and basic molecular biology as a major driver of Thermo's acquisition.

"All [Fermentas'] PCR products … are self-manufactured and self-invented or developed," Kennedy said. "And then of course they have the appropriate licenses and IP necessary to sell them with the classic ABI/Roche patent portfolio that exists in the area of PCR.

Lastly, Kennedy underscored Fermentas' sample-preparation expertise, particularly in the area of DNA and RNA purification, which is "another area we're very interested in," Kennedy said. "We've talked with their customers, and although they're probably more well-known in Europe than in the US, the consistent response we got from people was that [they] are very pleased with the quality [of these products] and the high level of service they provide."

Dx Puzzle Pieces

With Fermentas' broad portfolio of PCR, sample prep, and general molecular biology tools in hand; the recent acquisition of Finnzymes and its proprietary polymerases and miniature Piko brand thermal cyclers; and Thermo's own qPCR product launch last fall, it appears as if the company may be looking beyond PCR research tools and toward the PCR-based molecular diagnostics space.

The small footprint and relatively low price of the Piko, in particular, would seem to make it an attractive instrument for smaller clinical diagnostic labs, hospitals, or other small, non-central testing laboratories.

Indeed, Kennedy confirmed that Thermo is putting the pieces together to tackle a wide variety of PCR-based testing markets, including diagnostics. Thermo already has some in vitro diagnostic products in its portfolio – mainly immunoassays for sepsis and cardiovascular and pulmonary disease biomarkers – courtesy primarily of its $471 million acquisition of Brahms last year.

Molecular diagnostics, however, is likely not Thermo's first priority when considering the new PCR products. For example, food safety testing is an attractive target, Kennedy said, adding that the Finnzymes acquisition also garnered Thermo a PCR-based test, PathoProof, for detecting all main mastitis bacteria from bovine milk in approximately four hours.

"It's not just diagnostics, but all PCR-based testing that we're interested in," Kennedy said. "We're enabling our own R&D staff with all the tools necessary to make those products … available in those markets."

On the other end of the spectrum, Thermo, despite its reputation for instrumentation and automation products, has yet to offer a larger or higher throughput thermal cycler to offer customers for use with its rapidly growing PCR reagent portfolio.

"There is another market segment there, which is higher-throughput customers who are doing a lot more parallel processing," Kennedy said. "And while I can't speak specifically to whether we've got anything in mind, Thermo is always looking to add products to its portfolio.

"We see this as a growth market and a growth area of the business; and we're keeping our eyes open to make sure if there is something out there that would help us better serve our customers that we would take a serious look at it," he added.

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