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As it Readies US Lab, Germany's Inostics Moving Beyond Service Model with Digital PCR Tech

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By Ben Butkus

German molecular diagnostic services company Inostics is currently beta-testing its first assay kits featuring its BEAMing digital PCR technology, company officials said recently.

The kits are intended for sale to external labs interested in using them in biomarker discovery or companion diagnostic development, and would represent a departure from the contract research services strategy Inostics has employed to date.

In addition, Inostics recently opened the doors to its first US subsidiary at the Science and Technology Park at Johns Hopkins University, and will within the next two months begin offering discovery and development services similar to those currently offered in the company's Hamburg, Germany, headquarters.

Inostics was founded in 2008 by German clinical services firm Indivumed and scientists from Johns Hopkins University, including Bert Vogelstein and Kenneth Kinzler, some of the earliest innovators of digital PCR.

The company's core technology, called BEAMing (named after its four primary components: beads, emulsion, amplification, and magnetics), was invented by Vogelstein and colleagues, and marries emulsion-based digital PCR with magnetic beads, hybridization, and flow cytometry. BEAMing assays can detect and enumerate mutant DNA in a background of wild-type DNA at ratios greater than one in 10,000, according to the company.

Vogelstein's lab originally developed the BEAMing technology as a way to look for mutations in clinical samples. Inostics, having further refined the technique, was founded to provide that same service to customers, particularly pharmaceutical and biotech researchers looking to identify mutations that might serve as biomarkers in companion diagnostics.

And, although BEAMing has been shown to work for this type of application in multiple publications, the technique has been criticized in the past for being difficult to implement in the laboratory. Recognizing this, Inostics has in the past few years worked to make the assay more user friendly.

"The way it's done in the laboratory now has changed from a single-tube assay, where you had to work in tubes and [go through] a few adjacent steps … to an automated liquid-handling platform," Frank Diehl, Inostics' co-founder and CSO, told PCR Insider recently. "There is no plate change necessary, and we've eliminated all the centrifugation steps. It’s in a 96-well, single-plate format. And it's an open technology. It can be run on any liquid-handling system. That's one of the advantages, that it can use existing infrastructure in the laboratory."

Other than a liquid-handling platform, other laboratory requirements for running BEAMing assays include a thermal cycler and a flow cytometer, components that "most labs have in place," Diehl said, adding that Inostics has validated the assays on several different brands of the aforementioned instruments.

Diehl also noted that researchers can still perform BEAMing assays manually, thus eliminating the need for a liquid-handling apparatus; however, this would reduce the assay's throughput drastically.

Having developed a more simplified workflow for BEAMing, Inostics is now seeking to get assays based on the technology out to researchers interested in using it in their own labs.

"We have started the beta-testing phase for selling this to external labs," Diehl said. "The core business has been here in Hamburg as a service, and the Baltimore lab will also be a service lab. We develop assays on demand; or, we offer existing tests on the instruments we have here. This has to do with the throughput and just the way we handle the business right now. The vast majority of our customers are doing outsourcing anyway."

Diehl added that Inostics' longer-term strategy "would be to have a kit that includes the beads, the polymerase master mix, and fluorescent probes for specific mutations."

Most of Inostics' current contract customers and potential external customers are interested in using BEAMing technology to discover biomarkers and develop companion diagnostics around them, Diehl said.

"We have worked with 11 big pharma companies, and in total we have 29 customers in academia and biotech," he said. "But right now these are in the exploratory biomarker phase where they are trying to validate their biomarker strategies, and the goal is to later have this as a companion diagnostic for targeted therapies."

As such, the company is first beta-testing BEAMing kits with European customers, particularly large pharmaceutical companies, because of the lower regulatory hurdle for in vitro diagnostic development there.

In addition, Inostics has been working to secure IP related to assay content, especially biomarkers and pathways associated with various cancers, which it believes will help set it apart from its competitors in the digital PCR space such as Fluidigm, Life Technologies, QuantaLife, and RainDance Technologies.

"Many companies are now striving to increase their throughput, saying that they can do 10,000 or 20,000 [PCR reactions] per second," Philipp Angenendt, chief technology officer of Inostics, told PCR Insider. "We are well past that. We can do 100 million [reactions] for each well in a 96-well format, so we are not only focusing on the technology now, but moving into content. We have shown for the last five years that the technology works, that we can see that the mutations are corresponding with the tissue. So now we are past the technological development into real applications. Most of our competitors are still struggling with technological advances."

The company's largest IP score also stemmed from the Vogelstein lab at JHU: In 2009, Inostics obtained a worldwide exclusive license from the university to detect PIK3CA mutations using digital PCR, emulsion PCR, and other sequencing-based technologies. Mutations in the PIK3CA gene have been implicated in tumor cell proliferation in several cancer types, including breast and colon cancer, and thus the gene has become a major target of interest for pharmaceutical and biotech companies.

Privately owned Inostics has to this point subsisted on angel funding and its service business, Diehl said. Thus, even as it expands into the US and broadens its commercial offerings, the company does not plan to actively seek out new investment dollars.

"So far we have broken even," Diehl said. "We're driven by our service business, and we develop as we go."

But the company may eventually need additional funding in order to branch out beyond BEAMing assays and into other applications and research services.

"We are first focusing on the new lab, and doing this step by step," Angenendt said. "We don't want to be a company that has a great technology but only offers one thing. We do other things … such as sequencing and other aspects of mutations. We are not going to be a one-stop shop that does everything, but we do plan to offer a big chunk around mutation detection."


Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.

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