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Japan's Sysmex to Integrate Tech from Inostics, Partec for Personalized Medicine, CDx

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Japanese in vitro diagnostics firm Sysmex said this week that it has acquired a pair of German companies — molecular diagnostics services firm Inostics and flow cytometry specialist Partec — in a bid to bolster its personalized medicine and companion diagnostics development business.

In particular, Sysmex said that it plans to integrate Inostics' BEAMing molecular testing technology — which combines emulsion-based digital PCR with magnetic beads, hybridization, and flow cytometry — with Partec's highly automated flow cytometry platforms.

In addition, Sysmex said, it will offer on a global basis molecular assay services using the BEAMing technology, services that Inostics currently offers out of its Hamburg headquarters and through its CLIA-certified laboratory in Baltimore, Md. Sysmex noted that its acquisitions will also enhance its companion diagnostic activities in collaboration with pharmaceutical partners.

Inostics was founded in 2008 by the company Indivumed and scientists from Johns Hopkins University, including Bert Vogelstein and Kenneth Kinzler, who invented BEAMing, which stands for "beads, emulsion, amplification, and magnetic."

Like other droplet-based digital PCR techniques, BEAMing assays can detect and enumerate mutant DNA in a background of wild-type DNA at ratios greater than one in 10,000, and as such it is a promising platform on which to develop and offer so-called "liquid biopsies" — assays that can detect cancer cell DNA in a patient's blood for early detection of the disease.

Initially considered too complex a technique to implement for routine mutation testing in cancer, Inostics worked to streamline the method, and subsequently began offering research-use-only mutation detection assays out of its Hamburg location. In addition, in August 2011 the company began beta-testing BEAMing-based assay kits with various early-access users, and opened the doors to its first US offices at the Science and Technology Park at JHU (PCR Insider, 8/18/2011).

In the meantime, some independent publications demonstrated the potential of BEAMing as a tool for early cancer detection and monitoring, including a pair of studies published last year in Nature that specifically used the technology to detect drug resistance mediated by KRAS mutations in colorectal cancer patients months before treatment failure is observed (PCR Insider, 6/28/2012).

However, Inostics never did market assay kits based on BEAMing, instead deciding to use its in-house expertise to offer mutation-detection tests as a service. In May of this year, the company's clinical laboratory in Baltimore received CLIA licensure, allowing Inostics to begin offering its first test out of that location — the OncoBEAM tumor mutation test for the molecular analysis of tumor DNA shed from primary and metastatic tumors and circulating in a patient's blood (PCR Insider 5/30/2013).

Yet another study published in late July in Molecular Therapy-Nucleic Acids detailed how researchers from Massachusetts General Hospital developed a BEAMing-based method to detect mutations associated with glioblastoma brain tumors in RNA extracted from extracellular vesicles released from these tumors into patients' cerebrospinal fluid (PCR Insider 8/1/2013).

But that publication also served to highlight the difficulty of performing BEAMing routinely in a clinical laboratory, as the group eventually migrated their BEAMing assay onto RainDance Technologies' RainDrop digital PCR system, with an MGH research team member telling PCR Insider at the time that the BEAMing method was "very time-consuming and very manual."

Currently, performing BEAMing requires a liquid-handling platform, a thermal cycler, and a flow cytometer, instruments that most labs have in place. The technique can also be performed manually — albeit much more slowly — without a liquid handler.

The flow cytometry component is where Partec comes into play. It is unclear exactly how Sysmex plans to integrate BEAMing with Partec's flow cytometry platforms. Representatives from the company could not be reached for comment, while officials from Inostics and previous parent company Indivumed did not return calls or emails prior to the publication of this article.

Privately owned Partec is a well-established player in the flow cytometry space. It was founded in 1967 and brought to market the first fluorescence-based commercial flow cytometer. Sysmex noted in a statement that Partec has a strong presence in emerging markets and developing countries in areas such as HIV monitoring, malaria diagnostics, and other infectious diseases; while in developed countries it provides testing instruments to research institutions and industrial customers.

Sysmex also said in a statement that, "in addition to establishing new analytical platforms by integrating" Partec's flow cytometers with Inostics' digital PCR technology, it will "enter the personalized medicine business leveraging its global sales and support network," and its "companion diagnostics activities in collaboration with pharmaceutical companies will be enhanced."

As part of this, Sysmex will be able to offer Inostics' BEAMing-based mutation detection assays globally.

"With Sysmex, we expect [to achieve] our goal to make Inostics technology the leading approach for DNA-based cancer diagnostics for the worldwide benefit of cancer patients," Frank Diehl, a co-founder of Inostics who will continue to work for the company as chief scientific officer and managing director, said in a statement. "The fact that Sysmex has its European headquarters in the Hamburg area facilitates a smooth transition and an undelayed continuation of Inostics' business."

Indivumed, which is selling 100 percent of its Inostics shares to Sysmex, will also remain in the cancer diagnostics space. In a statement, the company said that it plans to "expand its tissue-based clinical research service business using a comprehensive and high-quality tumor biobank and its know-how in the analysis of proteins and cancer pathways for drug development and patient diagnostics."

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