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Bayer, Sysmex Inostics to Develop BEAMing CDx Tests for New Cancer Therapies

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When Japan's Sysmex disclosed two weeks ago that it had acquired molecular diagnostics services firm Inostics and flow cytometry specialist Partec, it noted that the purchases were designed to aid its foray into personalized medicine and companion diagnostics.

The company wasted no time in pursuing these markets, as this week Sysmex Inostics, the new MDx subsidiary of Sysmex, disclosed that it has signed a collaboration deal with Bayer Healthcare to develop blood-based companion diagnostics for targeted anti-cancer therapies being developed by Bayer.

Bayer had previously worked with Inostics on a research basis, but the companies inked a master collaboration agreement in September, a Bayer spokesperson told PCR Insider in an email this week. The agreement allows for the initiation of multiple projects over the course of five years and will continue until the last project expires or is terminated.

And while Sysmex's acquisition of Inostics was not the primary reason for the expanded partnership, "we appreciate the acquisition of Inostics by Sysmex as a major strategic step of both partners to sustain the efforts to expand the BEAMing technology on a global scale," the spokesperson said.

Under the agreement, Sysmex Inostics will develop blood-based diagnostic tests using its BEAMing (beads, emulsion, and amplification) technology, an ultra-sensitive digital PCR approach that can detect and enumerate mutant DNA in a background of wild-type DNA at ratios greater than one in 10,000.

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 to detect disease at a very early stage.

"Sysmex Inostics has proven blood-based companion diagnostic development [capabilities]," the Bayer spokesperson said. "The company's BEAMing tests enable a very sensitive analysis of circulating tumor DNA shed into the blood stream from tumors, which provides a non-invasive alternative to tumor biopsy to analyze the mutational status of a patient's tumor. Besides that, the BEAMing technology has potential for being used in patient monitoring and effective screening."

According to the spokesperson, Bayer and Sysmex Inostics will evaluate the potential of blood-based companion diagnostics across Bayer's entire oncology portfolio, with a particular focus on cancer types "where tumor biopsies are rather difficult," although she did not elaborate.

Currently, Bayer is applying a first blood-based companion diagnostic test in clinical trials to help select patients more likely to achieve a clinical benefit to an investigational anti-cancer agent it is developing, the spokesperson added, noting that the company could not share additional details about various projects at this time.

In general, the collaboration "will support Bayer's oncological development programs and underlines Bayer's commitment to a personalized medicine approach in oncology," the spokesperson said. "It provides an additional pillar of Bayer's strategy to access the optimal diagnostic technologies and partners to develop CDx for its various pipeline assets in oncology."

Last month, Bayer also entered into a strategic alliance with the Broad Institute to jointly develop and discover therapeutic agents that target cancer genome alterations.

For Sysmex Inostics, the collaboration is the first of what is expected to be several in the area of personalized medicine and companion diagnostic developments using the BEAMing technology.

Inostics was founded in Germany in 2008 by Indivumed and Johns Hopkins University scientists, who invented BEAMing. Early on Inostics offered research-use-only mutation detection assays out of its Hamburg headquarters. In 2011 it also 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).

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).

Two weeks ago, Sysmex announced that it had acquired Inostics for an undisclosed amount. At the same time, it disclosed that it had acquired Partec, another German company specializing in flow cytometry instrumentation (PCR Insider 9/26/2013).

Sysmex said that it plans to integrate the BEAMing technology with Partec's flow cytometry expertise to further enhance its molecular and companion diagnostic development platform.

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